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The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C) lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two weeks (Q14D) in hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin, or who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Population A | Experimental | A total of 9 groups in two population. Population A comprises hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin. A subject who is receiving a stable dose of atorvastatin will be randomized into one out of 5 dose groups. |
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| Population B | Experimental | A total of 9 groups in two population. Population B comprises hypercholesterolemic Japanese subjects who are naïve for a treatment by lipid lowering drug and whose fasting LDL-cholesterol is not controlled. A subject who is treatment naïve will be randomized into one out of 4 dose groups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bococizumab (PF-04950615;RN316) | Drug | Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 | LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | Baseline, Day 85 |
| Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 113 | LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | Baseline, Day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Low Density Lipoprotein-Cholesterol (LDL-C) | LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maebashi Hirosegawa Clinic | Maebashi | Gunma | 371-0022 | Japan | ||
| Yokohama Minoru Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37994400 | Derived | Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22. | |
| 31549625 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin + PF-04950615 50 mg | Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Bococizumab (PF-04950615;RN316) | Drug | Atorvastatin plus PF-04950615 100 mg Q14D SC for 16 week |
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| Bococizumab (PF-04950615;RN316) | Drug | Atorvastatin plus PF-04950615 150 mg Q14D SC for 16 week |
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| Placebo | Drug | Atorvastatin plus PF-04950615 Placebo Q14D SC for 16 week |
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| Ezetimibe | Drug | Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open) |
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| Bococizumab (PF-04950615;RN316) | Drug | 50 mg Q14D SC for 16 week |
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| Bococizumab (PF-04950615;RN316) | Drug | 100 mg Q14D SC for 16 week |
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| Bococizumab (PF-04950615;RN316) | Drug | 150 mg Q14D SC for 16 week |
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| Placebo | Drug | Placebo Q14D SC for 16 week |
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| Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
| Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 and Day 113 | LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | Baseline, Day 85, 113 |
| Total Cholesterol (TC) | Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
| Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113 | Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | Baseline, Day 85, 113 |
| Percent Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113 | Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | Baseline, Day 85, 113 |
| Apolipoprotein B (ApoB) | ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
| Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113 | ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | Baseline, Day 85, 113 |
| Percent Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113 | ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | Baseline, Day 85, 113 |
| Apolipoprotein A-I (ApoA-I) | ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
| Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113 | ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | Baseline, Day 85, 113 |
| Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113 | ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | Baseline, Day 85, 113 |
| Apolipoprotein A-II (ApoA-II) | ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
| Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113 | ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | Baseline, Day 85, 113 |
| Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113 | ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | Baseline, Day 85, 113 |
| Lipoprotein (a) (Lp[a]) | Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
| Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113 | Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | Baseline, Day 85, 113 |
| Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113 | Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | Baseline, Day 85, 113 |
| High Density Lipoprotein- Cholesterol (HDL-C) | HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
| Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113 | HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | Baseline, Day 85, 113 |
| Percent Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113 | HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | Baseline, Day 85, 113 |
| Very Low Density Lipoprotein-Cholesterol (VLDL-C) | VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
| Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113 | VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | Baseline, Day 85, 113 |
| Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113 | VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | Baseline, Day 85, 113 |
| Triglyceride (TG) | Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
| Change From Baseline in Triglyceride (TG) at Day 85 and Day 113 | Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | Baseline, Day 85, 113 |
| Percent Change From Baseline in Triglyceride (TG) at Day 85 and Day 113 | Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | Baseline, Day 85, 113 |
| Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) | Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
| Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113 | Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | Baseline, Day 85, 113 |
| Percent Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113 | Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | Baseline, Day 85, 113 |
| Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio | Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
| Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113 | Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | Baseline, Day 85, 113 |
| Percent Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113 | Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | Baseline, Day 85, 113 |
| Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio | Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
| Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113 | Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | Baseline, Day 85, 113 |
| Percent Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113 | Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | Baseline, Day 85, 113 |
| Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 10, 25, 40, 70 and 100 Milligram Per Deciliter | LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. | Baseline up to Day 113 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 169 that were absent before treatment or that worsened relative to pretreatment state. Adverse events included treatment emergent injection site adverse events and any clinically significant abnormal laboratory value. | Baseline up to Day 169 |
| Number of Participants With Anti-Drug Antibody (ADA) Response | Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=6.23 for PF-04950615 were considered ADA positive. | Baseline up to Day 169 |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615 | Area under the plasma concentration time-curve from time zero to end of dosing interval (tau). This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615. | Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose) |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-04950615 | Area under the plasma concentration-time profile from time zero extrapolated to infinite time. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615. | Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose) |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615 | Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615. | Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose) |
| Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615. | Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hr post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose) |
| Minimum Observed Plasma Trough Concentration (Cmin) of PF-04950615 | This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615. | Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose) |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615. | Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose) |
| Terminal Elimination Half-Life (t1/2) of PF-04950615 | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615. | Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose) |
| Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) | Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =6.99 nanogram per milliliter [ng/mL]) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Day 1, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141 |
| Yokohama |
| Kanagawa |
| 232-0064 |
| Japan |
| Heishinkai Medical Group Incorporated OCROM Clinic | Suita | Osaka | 565-0853 | Japan |
| Meiwa Hospital | Chiyoda-ku | Tokyo | 101-0041 | Japan |
| Tokyo-Eki Center-building Clinic | Chuo-ku | Tokyo | 103-0027 | Japan |
| Heishinkai Medical Group Incorporated ToCROM Clinic | Shinjuku-ku | Tokyo | 160-0022 | Japan |
| Clinical Research Hospital Tokyo | Shinjuku-ku | Tokyo | 162-0053 | Japan |
| Oda Clinic | Shinjuku-ku | Tokyo | 169-0072 | Japan |
| Sekino Hospital | Toshima-ku | Tokyo | 171-0014 | Japan |
| Yokote K, Suzuki A, Li Y, Matsuoka N, Teramoto T. Pharmacokinetics and exploratory efficacy biomarkers of bococizumab, an anti-PCSK9 monoclonal antibody, in hypercholesterolemic Japanese subjects . Int J Clin Pharmacol Ther. 2019 Dec;57(12):575-589. doi: 10.5414/CP203418. |
| 28539539 | Derived | Yokote K, Kanada S, Matsuoka O, Sekino H, Imai K, Tabira J, Matsuoka N, Chaudhuri S, Teramoto T. Efficacy and Safety of Bococizumab (RN316/PF-04950615), a Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, in Hypercholesterolemic Japanese Subjects Receiving a Stable Dose of Atorvastatin or Treatment-Naive - Results From a Randomized, Placebo-Controlled, Dose-Ranging Study. Circ J. 2017 Sep 25;81(10):1496-1505. doi: 10.1253/circj.CJ-16-1310. Epub 2017 May 23. |
| FG001 | Atorvastatin + PF-04950615 100 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| FG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| FG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| FG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| FG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
| FG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
| FG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
| FG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included all randomized and non-randomized participants who were administered at least 1 dose of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin + PF-04950615 50 mg | Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| BG001 | Atorvastatin + PF-04950615 100 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| BG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| BG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| BG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| BG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
| BG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
| BG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
| BG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 | LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | Full analysis set (FAS) included all the participants who were randomized and administered at least 1 dose of study treatment. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 85 |
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| Primary | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 113 | LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 113 |
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| Secondary | Low Density Lipoprotein-Cholesterol (LDL-C) | LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
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| Secondary | Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 and Day 113 | LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 85, 113 |
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| Secondary | Total Cholesterol (TC) | Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
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| Secondary | Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113 | Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 85, 113 |
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| Secondary | Percent Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113 | Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 85, 113 |
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| Secondary | Apolipoprotein B (ApoB) | ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
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| Secondary | Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113 | ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 85, 113 |
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| Secondary | Percent Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113 | ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 85, 113 |
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| Secondary | Apolipoprotein A-I (ApoA-I) | ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
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| Secondary | Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113 | ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 85, 113 |
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| Secondary | Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113 | ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 85, 113 |
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| Secondary | Apolipoprotein A-II (ApoA-II) | ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
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| Secondary | Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113 | ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 85, 113 |
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| Secondary | Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113 | ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 85, 113 |
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| Secondary | Lipoprotein (a) (Lp[a]) | Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
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| Secondary | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113 | Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 85, 113 |
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| Secondary | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113 | Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 85, 113 |
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| Secondary | High Density Lipoprotein- Cholesterol (HDL-C) | HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
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| Secondary | Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113 | HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 85, 113 |
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| Secondary | Percent Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113 | HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 85, 113 |
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| Secondary | Very Low Density Lipoprotein-Cholesterol (VLDL-C) | VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
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| Secondary | Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113 | VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 85, 113 |
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| Secondary | Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113 | VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 85, 113 |
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| Secondary | Triglyceride (TG) | Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
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| Secondary | Change From Baseline in Triglyceride (TG) at Day 85 and Day 113 | Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 85, 113 |
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| Secondary | Percent Change From Baseline in Triglyceride (TG) at Day 85 and Day 113 | Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 85, 113 |
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| Secondary | Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) | Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
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| Secondary | Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113 | Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 85, 113 |
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| Secondary | Percent Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113 | Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 85, 113 |
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| Secondary | Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio | Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | ratio | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
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| Secondary | Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113 | Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | ratio | Baseline, Day 85, 113 |
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| Secondary | Percent Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113 | Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 85, 113 |
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| Secondary | Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio | Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | ratio | Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169 |
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| Secondary | Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113 | Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | ratio | Baseline, Day 85, 113 |
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| Secondary | Percent Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113 | Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 85, 113 |
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| Secondary | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 10, 25, 40, 70 and 100 Milligram Per Deciliter | LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. | FAS included all the participants who were randomized and administered at least 1 dose of study treatment. The outcome measure was planned to be analyzed for all the reporting groups except Atorvastatin + Ezetimibe 10 mg. | Posted | Number | percentage of participants | Baseline up to Day 113 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 169 that were absent before treatment or that worsened relative to pretreatment state. Adverse events included treatment emergent injection site adverse events and any clinically significant abnormal laboratory value. | Safety analysis set included all randomized and non-randomized participants who were administered at least 1 dose of study treatment. | Posted | Number | participants | Baseline up to Day 169 |
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| Secondary | Number of Participants With Anti-Drug Antibody (ADA) Response | Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=6.23 for PF-04950615 were considered ADA positive. | Safety analysis set included all randomized and non-randomized participants who were administered at least 1 dose of study treatment. This outcome measure was planned to be analyzed for all the reporting groups except for Atorvastatin + Ezetimibe 10 mg. | Posted | Number | participants | Baseline up to Day 169 |
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| Secondary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615 | Area under the plasma concentration time-curve from time zero to end of dosing interval (tau). This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615. | The pharmacokinetic (PK) parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*day per milliliter(mcg*day/mL) | Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose) |
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| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-04950615 | Area under the plasma concentration-time profile from time zero extrapolated to infinite time. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615. | The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg*day/mL | Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose) |
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| Secondary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615 | Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615. | The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, N signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg*day/mL | Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615. | The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (mcg/mL) | Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hr post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose) |
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| Secondary | Minimum Observed Plasma Trough Concentration (Cmin) of PF-04950615 | This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615. | The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, N signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose) |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615. | The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | Posted | Median | Full Range | day | Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose) |
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| Secondary | Terminal Elimination Half-Life (t1/2) of PF-04950615 | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615. | The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, N signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | day | Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose) |
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| Secondary | Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) | Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =6.99 nanogram per milliliter [ng/mL]) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points. | PK concentration population included participants in FAS who have at least 1 concentration of either PF-04950615, PCSK9 or atorvastatin or its active metabolites. This outcome measure was planned to be analyzed for all the reporting groups except for Atorvastatin + Ezetimibe 10 mg. | Posted | Mean | Standard Deviation | ng/mL | Day 1, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atorvastatin + PF-04950615 50 mg | Participants with fasting lipoprotein cholesterol (LDL-C) level (greater than or equal to [>=]100 milligram per deciliter [mg/dL]) received atorvastatin along with PF-04950615 50 milligram (mg) subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. | 1 | 25 | 10 | 25 | ||
| EG001 | Atorvastatin + PF-04950615 100 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. | 0 | 24 | 12 | 24 | ||
| EG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. | 0 | 24 | 12 | 24 | ||
| EG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. | 1 | 26 | 10 | 26 | ||
| EG004 | Atorvastatin + Ezetimibe 10 mg QD PO | Participants received Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open). | 0 | 22 | 2 | 22 | ||
| EG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. | 0 | 25 | 11 | 25 | ||
| EG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. | 1 | 25 | 11 | 25 | ||
| EG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. | 0 | 24 | 11 | 24 | ||
| EG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. | 0 | 23 | 9 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Ejaculation disorder | Reproductive system and breast disorders | MedDRA 17.1 | Non-systematic Assessment | Gender specific adverse event. |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000598888 | bococizumab |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| 18-44 years |
|
| 45-64 years |
|
| Greater than or equal to (>=) 65 years |
|
| Male |
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| Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction. | Mixed Models Analysis | One-sided p-value (adjusted for multiplicity) was derived from the MMRM model. | <0.001 | Adjusted Mean Difference | -66.754 | Standard Error of the Mean | 3.912 | 2-Sided | 95 | -74.523 | -58.986 | Superiority or Other |
| Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction. | Mixed Models Analysis | One-sided p-values (adjusted for multiplicity) was derived from the MMRM model. | <0.001 | Adjusted Mean Difference | -71.534 | Standard Error of the Mean | 3.903 | 2-Sided | 95 | -79.284 | -63.784 | Superiority or Other |
| Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction. | Mixed Models Analysis | One-sided p-values (adjusted for multiplicity) was derived from the MMRM model. | <0.001 | Adjusted Mean Difference | -47.531 | Standard Error of the Mean | 4.016 | 2-Sided | 95 | -55.511 | -39.551 | Superiority or Other |
| Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction. | Mixed Models Analysis | One-sided p-values (adjusted for multiplicity) was derived from the MMRM model. | <0.001 | Adjusted Mean Difference | -62.624 | Standard Error of the Mean | 3.993 | 2-Sided | 95 | -70.557 | -54.691 | Superiority or Other |
| Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction. | Mixed Models Analysis | One-sided p-values (adjusted for multiplicity) was derived from the MMRM model. | <0.001 | Adjusted Mean Difference | -64.268 | Standard Error of the Mean | 3.955 | 2-Sided | 95 | -72.128 | -56.409 | Superiority or Other |
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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|
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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|
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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|
|
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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|
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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|
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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|
|
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
|
|
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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|
|
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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|
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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|
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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|
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
|
|
|
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
|
|
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
|
|
|
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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|
|
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
|
|
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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| Atorvastatin + PF-04950615 150 mg |
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG005 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
|
|
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 100 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy.
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | Atorvastatin + Ezetimibe 10 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with ezetimibe 10 mg tablet orally, once daily from Day 1 up to Day 112. Participants were on self-administered stable background atorvastatin therapy. |
| OG005 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG008 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
|
|
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG005 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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|
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG004 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG005 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
|
|
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG004 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG005 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
|
|
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG004 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG005 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
|
|
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG004 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG005 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
|
|
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG004 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG005 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
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| OG002 |
| Atorvastatin + PF-04950615 150 mg |
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG004 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG005 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
|
|
| Atorvastatin + PF-04950615 150 mg |
Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG004 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG005 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
|
|
| OG002 | Atorvastatin + PF-04950615 150 mg | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 150 mg subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG003 | Atorvastatin + PF-04950615 Placebo | Participants with fasting LDL-C level (>=100 [mg/dL]) received atorvastatin along with PF-04950615 placebo subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were on self-administered stable background atorvastatin therapy. |
| OG004 | PF-04950615 50 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 50 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG005 | PF-04950615 100 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 100 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG006 | PF-04950615 150 mg | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 150 mg, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naïve to a treatment by lipid lowering drug. |
| OG007 | PF-04950615 Placebo | Participants with fasting LDL-C level (>=130 [mg/dL]) received PF-04950615 placebo, subcutaneous injection, once daily on Day 1, 15, 29, 43, 57, 71, 85 and 99. Participants were naive to a treatment by lipid lowering drug. |
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