Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I1V-JE-EIAE | Other Identifier | Eli Lilly and Company |
Not provided
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The purpose of this study is to determine if 12 weeks of treatment with LY2484595 administered as a monotherapy will significantly increase high-density lipoprotein cholesterol (HDL-C) and decrease low-density lipoprotein cholesterol (LDL-C) in Japanese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 milligrams (mg) LY2484595 | Experimental | Administered orally once daily for 12 weeks |
|
| 100 mg LY2484595 | Experimental | Administered orally once daily for 12 weeks |
|
| 500 mg LY2484595 | Experimental | Administered orally once daily for 12 weeks |
|
| Placebo | Placebo Comparator | Administered orally once daily for 12 weeks |
|
| 10 mg Atorvastatin | Active Comparator | Administered orally once daily for 12 weeks |
|
| 100 mg LY2484595 + 10 mg Atorvastatin | Experimental | Administered orally once daily for 12 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2484595 | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo | Percent change from baseline = 100*(post-baseline assessment - baseline assessment)/baseline assessment. Higher values in the percent change from baseline represented an improvement for HDL-C and lower values in the percent change from baseline represented an improvement for LDL-C. Least Squares (LS) mean was adjusted for baseline value of the variable analyzed. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | Percent change from baseline = 100*(post-baseline assessment - baseline assessment)/baseline assessment. An increase in the percent change from baseline represented an improvement for HDL-C and a decrease in the percent change from baseline represents an improvement for LDL-C. LS mean was adjusted for baseline value of the variable analyzed. |
Not provided
Inclusion Criteria:
Have Low HDL-C or High LDL-C criteria as follows:
Low HDL lipid criteria:
HDL-C <45 milligrams per deciliter (mg/dL) (men) and <50 mg/dL (women), and
LDL-C according to Japan Atherosclerosis Society (JAS) guidelines as follows:
Fasting Triglycerides (TG) <400 mg/dL
or
High LDL-C lipid criteria:
HDL-C <100 mg/dL, and
LDL-C according to JAS guidelines as follows:
Fasting TG <400 mg/dL
Note: Subjects with diabetes regarded as 3+ risk factors
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hyōgo | 660-0814 |
Prior to randomization, participants stopped lipid-related concomitant medications and started a diet therapy in accordance with the Japan Atherosclerosis Society guidelines for diagnosis and prevention of atherosclerotic cardiovascular disease.
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| ID | Title | Description |
|---|---|---|
| FG000 | 30 mg LY2484595 | The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 30-milligram (mg) tablet |
| FG001 | 100 mg LY2484595 | The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet |
| FG002 | 500 mg LY2484595 | The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets |
| FG003 | Placebo | The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule |
| FG004 | 10 mg Atorvastatin | The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets |
| FG005 | 100 mg LY2484595 + 10 mg Atorvastatin | The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule LY2484595: A single 100-mg tablet Placebo (LY2484595): 4 tablets |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 30 mg LY2484595 | The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 30-mg tablet |
| BG001 | 100 mg LY2484595 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin | Percent change from baseline = 100*(post-baseline assessment - baseline assessment)/baseline assessment. An increase in the percent change from baseline represented an improvement for HDL-C and a decrease in the percent change from baseline represents an improvement for LDL-C. LS mean was adjusted for baseline value of the variable analyzed. | All randomized participants who took at least 1 dose of double-blind study medication, had a baseline and at least 1 post-baseline HDL-C measurement (mITT population), and had at least 1 post-baseline value of the response variable for the specified time frame. | Posted | Least Squares Mean | Standard Error | percent change | Baseline, Weeks 2, 4, and 8 |
|
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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 | 30 mg LY2484595 | The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 30-mg tablet |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (14.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
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| ID | Term |
|---|---|
| C568301 | evacetrapib |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
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|
| Placebo | Drug | Administered orally |
|
| Atorvastatin | Drug | Administered orally |
|
| Baseline, Weeks 2, 4, and 8 |
| Pharmacokinetics - Area Under the Curve (AUC) of LY2484595 and Atorvastatin | Weeks 2, 4, 8, 12 (predose and postdose), and Week 16 |
| The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | All rash cases were adjudicated by a central dermatologist blinded to treatment assignment according to a study-specific Clinical Events Committee (CEC) charter. Rash events were assessed according to clinical relevance (severity). Categories included high risk, low risk, not a relevant dermatosis, or insufficient documentation for determination. High risk rashes included anaphylaxis, toxic epidermal necrolysis, Stevens Johnson Syndrome, Drug Reaction with Eosinophilia and System Symptoms (DRESS), urticaria/angioedema, vasculitis, erythroderma, and lupus-like reaction. All other rashes were considered low risk or not a relevant dermatosis per the Investigator's clinical opinion. A participant could be reported in multiple categories. | Baseline through Week 12 |
| Change From Baseline to 12 Weeks in Blood Pressure | Blood pressure reported as systolic blood pressure (SBP) and diastolic blood pressure (DBP). LS mean was adjusted for baseline value of the variable analyzed. | Baseline and Week 12 |
| Change From Baseline to 12 Weeks in Aldosterone | LS mean was adjusted for baseline value of the variable analyzed. | Baseline and Week 12 |
| Change From Baseline to 12 Weeks in Plasma Renin Activity | LS mean was adjusted for baseline value of the variable analyzed. | Baseline and Week 12 |
| Change From Baseline to 12 Weeks in Serum Sodium | LS mean was adjusted for baseline value of the variable analyzed. | Baseline and Week 12 |
| Change From Baseline to 12 Weeks in Serum Bicarbonate | LS mean was adjusted for baseline value of the variable analyzed. | Baseline and Week 12 |
| Number of Myopathy and Liver Injury Events | Myopathy events were considered muscle-related treatment emergent adverse events (TEAEs) and liver injury events were considered hepatic disorder-related TEAEs reported per Medical Dictionary for Regulatory Activities (MedDRA). An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs were newly occurring AEs or AEs worsening after first dose. | Baseline through Week 12 |
| Change From Baseline to 12 Week Endpoint in Highly-Sensitive C-Reactive Protein (hsCRP) | LS mean was adjusted for baseline value of the variable analyzed. | Baseline and Week 12 |
| Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | Plasma CETP activity assay employed a fluorometric method to determine the CETP transfer activity. Percent change from baseline = 100*(post-baseline assessment - baseline assessment)/baseline assessment. An increase in the percent change from baseline represented an improvement. LS mean was adjusted for baseline value of the variable analyzed. | Baseline, Weeks 4, 8, and 12 |
| Change From Baseline in Plasma CETP Mass | Plasma CETP mass assay was a solid-phase enzyme-linked immunosorbent assay (ELISA) designated to measure human CETP mass which employed the quantitative enzyme immunoassay principle. An increase in plasma CETP mass represented an improvement. LS mean was adjusted for baseline value of the variable analyzed. | Baseline, Weeks 4, 8, and 12 |
| Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kanagawa | 231-0023 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kyoto | 615-8125 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Osaka | 560-0005 | Japan |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tokyo | 111-0052 | Japan |
| Entry Criterion Not Met |
|
| Withdrawal by Subject |
|
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 100-mg tablet
| BG002 | 500 mg LY2484595 | The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets |
| BG003 | Placebo | The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule |
| BG004 | 10 mg Atorvastatin | The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets |
| BG005 | 100 mg LY2484595 + 10 mg Atorvastatin | The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule LY2484595: A single 100-mg tablet Placebo (LY2484595): 4 tablets |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
| Height | Mean | Standard Deviation | centimeters (cm) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilograms per square meter (kg/m²) |
|
| Low-Density Lipoprotein Cholesterol (LDL-C) | Mean | Standard Deviation | milligrams per deciliter (mg/dL) |
|
| High-Density Lipoprotein Cholesterol (HDL-C) | Mean | Standard Deviation | milligrams per deciliter (mg/dL) |
|
| Fasting Triglycerides (TG) | Mean | Standard Deviation | milligrams per deciliter (mg/dL) |
|
| Systolic Blood Pressure | Mean | Standard Deviation | millimeters of mercury (mm Hg) |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | millimeters of mercury (mm Hg) |
|
| Pulse Rate | Mean | Standard Deviation | beats per minute (bpm) |
|
The following were administered orally once daily for 12 weeks:
Placebo (LY2484595): 4 tablets
Placebo (Atorvastatin): 1 capsule
LY2484595: A single 30-milligram (mg) tablet
| OG001 | 100 mg LY2484595 | The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet |
| OG002 | 500 mg LY2484595 | The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets |
| OG003 | Placebo | The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule |
| OG004 | 10 mg Atorvastatin | The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets |
| OG005 | 100 mg LY2484595 + 10 mg Atorvastatin | The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule LY2484595: A single 100-mg tablet Placebo (LY2484595): 4 tablets |
|
|
|
| Secondary | Pharmacokinetics - Area Under the Curve (AUC) of LY2484595 and Atorvastatin | Participants who were administered LY2484595 or LY2484595 + Atorvastatin and had evaluable pharmacokinetic (PK) samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours per milliliter (ng*h/mL) | Weeks 2, 4, 8, 12 (predose and postdose), and Week 16 |
|
|
|
| Secondary | The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12 | All rash cases were adjudicated by a central dermatologist blinded to treatment assignment according to a study-specific Clinical Events Committee (CEC) charter. Rash events were assessed according to clinical relevance (severity). Categories included high risk, low risk, not a relevant dermatosis, or insufficient documentation for determination. High risk rashes included anaphylaxis, toxic epidermal necrolysis, Stevens Johnson Syndrome, Drug Reaction with Eosinophilia and System Symptoms (DRESS), urticaria/angioedema, vasculitis, erythroderma, and lupus-like reaction. All other rashes were considered low risk or not a relevant dermatosis per the Investigator's clinical opinion. A participant could be reported in multiple categories. | All randomized participants who took at least 1 dose of double-blind study medication intent-to-treat (ITT) population. | Posted | Number | events | Baseline through Week 12 |
|
|
|
| Secondary | Change From Baseline to 12 Weeks in Blood Pressure | Blood pressure reported as systolic blood pressure (SBP) and diastolic blood pressure (DBP). LS mean was adjusted for baseline value of the variable analyzed. | All randomized participants who took at least 1 dose of double-blind study medication (ITT population) and had a baseline and at least 1 post-baseline value of the response variable. | Posted | Least Squares Mean | Standard Error | millimeters of mercury (mm Hg) | Baseline and Week 12 |
|
|
|
|
| Secondary | Change From Baseline to 12 Weeks in Aldosterone | LS mean was adjusted for baseline value of the variable analyzed. | All randomized participants who took at least 1 dose of double-blind study medication (ITT population) and had a baseline and at least 1 post-baseline aldosterone measurement. | Posted | Least Squares Mean | Standard Error | nanograms per deciliter (ng/dL) | Baseline and Week 12 |
|
|
|
|
| Secondary | Change From Baseline to 12 Weeks in Plasma Renin Activity | LS mean was adjusted for baseline value of the variable analyzed. | All randomized participants who took at least 1 dose of double-blind study medication (ITT population) and had a baseline and at least 1 post-baseline plasma renin activity measurement. | Posted | Least Squares Mean | Standard Error | nanograms per milliliter per hour | Baseline and Week 12 |
|
|
|
|
| Secondary | Change From Baseline to 12 Weeks in Serum Sodium | LS mean was adjusted for baseline value of the variable analyzed. | All randomized participants who took at least 1 dose of double-blind study medication (ITT population) and had a baseline and at least 1 post-baseline serum sodium measurement. | Posted | Least Squares Mean | Standard Error | milliequivalents per liter (mEq/L) | Baseline and Week 12 |
|
|
|
|
| Secondary | Change From Baseline to 12 Weeks in Serum Bicarbonate | LS mean was adjusted for baseline value of the variable analyzed. | All randomized participants who took at least 1 dose of double-blind study medication (ITT population) and had a baseline and at least 1 post-baseline serum bicarbonate measurement. | Posted | Least Squares Mean | Standard Error | milliequivalents per liter (mEq/L) | Baseline and Week 12 |
|
|
|
|
| Secondary | Number of Myopathy and Liver Injury Events | Myopathy events were considered muscle-related treatment emergent adverse events (TEAEs) and liver injury events were considered hepatic disorder-related TEAEs reported per Medical Dictionary for Regulatory Activities (MedDRA). An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs were newly occurring AEs or AEs worsening after first dose. | All randomized participants who took at least 1 dose of double-blind study medication (ITT population). | Posted | Number | events | Baseline through Week 12 |
|
|
|
| Secondary | Change From Baseline to 12 Week Endpoint in Highly-Sensitive C-Reactive Protein (hsCRP) | LS mean was adjusted for baseline value of the variable analyzed. | All randomized participants who took at least 1 dose of double-blind study medication, had a baseline and at least 1 post-baseline HDL-C measurement (mITT population), and had at least 1 post-baseline hsCRP measurement. | Posted | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | Baseline and Week 12 |
|
|
|
|
| Secondary | Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity | Plasma CETP activity assay employed a fluorometric method to determine the CETP transfer activity. Percent change from baseline = 100*(post-baseline assessment - baseline assessment)/baseline assessment. An increase in the percent change from baseline represented an improvement. LS mean was adjusted for baseline value of the variable analyzed. | All randomized participants who took at least 1 dose of double-blind study medication, had a baseline and at least 1 post-baseline HDL-C measurement (mITT population), and had at least 1 post-baseline CETP activity measurement. | Posted | Least Squares Mean | Standard Error | percent change in CETP activity | Baseline, Weeks 4, 8, and 12 |
|
|
|
|
| Secondary | Change From Baseline in Plasma CETP Mass | Plasma CETP mass assay was a solid-phase enzyme-linked immunosorbent assay (ELISA) designated to measure human CETP mass which employed the quantitative enzyme immunoassay principle. An increase in plasma CETP mass represented an improvement. LS mean was adjusted for baseline value of the variable analyzed. | All randomized participants who took at least 1 dose of double-blind study medication, had a baseline and at least 1 post-baseline HDL-C measurement (mITT population), and had at least 1 post-baseline CETP mass measurement. | Posted | Least Squares Mean | Standard Error | micrograms per milliliter (µg/mL) | Baseline, Weeks 4, 8, and 12 |
|
|
|
|
| Primary | Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo | Percent change from baseline = 100*(post-baseline assessment - baseline assessment)/baseline assessment. Higher values in the percent change from baseline represented an improvement for HDL-C and lower values in the percent change from baseline represented an improvement for LDL-C. Least Squares (LS) mean was adjusted for baseline value of the variable analyzed. | All randomized participants who took at least 1 dose of double-blind study medication, had a baseline and at least 1 post-baseline HDL-C measurement [modified intent-to-treat (mITT) population], and also completed the Week 12 visit. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and Week 12 |
|
|
|
|
| 0 |
| 27 |
| 12 |
| 27 |
| EG001 | 100 mg LY2484595 | The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 4 tablets Placebo (Atorvastatin): 1 capsule LY2484595: A single 100-mg tablet | 0 | 28 | 12 | 28 |
| EG002 | 500 mg LY2484595 | The following were administered orally once daily for 12 weeks: Placebo (Atorvastatin): 1 capsule LY2484595: five 100-mg tablets | 1 | 27 | 10 | 27 |
| EG003 | Placebo | The following were administered orally once daily for 12 weeks: Placebo (LY2484595): 5 tablets Placebo (Atorvastatin): 1 capsule | 1 | 28 | 8 | 28 |
| EG004 | 10 mg Atorvastatin | The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule Placebo (LY2484595): 5 tablets | 0 | 27 | 10 | 27 |
| EG005 | 100 mg LY2484595 + 10 mg Atorvastatin | The following were administered orally once daily for 12 weeks: Atorvastatin: A single 10-mg capsule LY2484595: A single 100-mg tablet Placebo (LY2484595): 4 tablets | 0 | 28 | 10 | 28 |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Traumatic lung injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Periproctitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Pertussis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
Not provided
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| High risk |
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| Not a relevant dermatosis |
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| Insufficient documentation for determination |
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| DBP |
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| Mixed Models Analysis |
Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. |
| 0.257 |
The P-value is for change from baseline in SBP at Week 12. |
| LS Mean Difference |
| 2.83 |
| Standard Error of the Mean |
| 2.48 |
| 2-Sided |
| 90 |
| -1.28 |
| 6.94 |
| Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | 0.021 | The P-value is for change from baseline in SBP at Week 12. | LS Mean Difference | 5.90 | Standard Error of the Mean | 2.54 | 2-Sided | 90 | 1.70 | 10.10 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | 0.829 | The P-value is for change from baseline in SBP at Week 12. | LS Mean Difference | -0.54 | Standard Error of the Mean | 2.52 | 2-Sided | 90 | -4.71 | 3.62 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | 0.603 | The P-value is for change from baseline in DBP at Week 12. | LS Mean Difference | 0.78 | Standard Error of the Mean | 1.50 | 2-Sided | 90 | -1.69 | 3.24 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | 0.656 | The P-value is for change from baseline in DBP at Week 12. | LS Mean Difference | -0.66 | Standard Error of the Mean | 1.48 | 2-Sided | 90 | -3.11 | 1.78 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | 0.228 | The P-value is for change from baseline in DBP at Week 12. | LS Mean Difference | 1.83 | Standard Error of the Mean | 1.52 | 2-Sided | 90 | -0.67 | 4.34 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | 0.516 | The P-value is for change from baseline in DBP at Week 12. | LS Mean Difference | -0.98 | Standard Error of the Mean | 1.51 | 2-Sided | 90 | -3.47 | 1.51 | Superiority or Other |
| Mixed Models Analysis |
Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. |
| 0.970 |
| LS Mean Difference |
| 0.04 |
| Standard Error of the Mean |
| 1.12 |
| 2-Sided |
| 90 |
| -1.82 |
| 1.90 |
| Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | 0.824 | LS Mean Difference | 0.26 | Standard Error of the Mean | 1.16 | 2-Sided | 90 | -1.66 | 2.17 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | 0.769 | LS Mean Difference | -0.33 | Standard Error of the Mean | 1.12 | 2-Sided | 90 | -2.18 | 1.52 | Superiority or Other |
| Mixed Models Analysis |
Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. |
| 0.503 |
| LS Mean Difference |
| 0.22 |
| Standard Error of the Mean |
| 0.33 |
| 2-Sided |
| 90 |
| -0.32 |
| 0.76 |
| Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | 0.988 | LS Mean Difference | 0.00 | Standard Error of the Mean | 0.33 | 2-Sided | 90 | -0.53 | 0.54 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | 0.207 | LS Mean Difference | -0.41 | Standard Error of the Mean | 0.32 | 2-Sided | 90 | -0.95 | 0.13 | Superiority or Other |
| Mixed Models Analysis |
Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. |
| 0.990 |
| LS Mean Difference |
| -0.01 |
| Standard Error of the Mean |
| 0.43 |
| 2-Sided |
| 90 |
| -0.71 |
| 0.70 |
| Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | 0.565 | LS Mean Difference | 0.25 | Standard Error of the Mean | 0.44 | 2-Sided | 90 | -0.47 | 0.97 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | 0.678 | LS Mean Difference | 0.18 | Standard Error of the Mean | 0.43 | 2-Sided | 90 | -0.53 | 0.89 | Superiority or Other |
| Mixed Models Analysis |
Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. |
| 0.869 |
| LS Mean Difference |
| 0.10 |
| Standard Error of the Mean |
| 0.61 |
| 2-Sided |
| 90 |
| -0.90 |
| 1.10 |
| Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | 0.869 | LS Mean Difference | 0.10 | Standard Error of the Mean | 0.62 | 2-Sided | 90 | -0.92 | 1.13 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | 0.317 | LS Mean Difference | 0.61 | Standard Error of the Mean | 0.61 | 2-Sided | 90 | -0.40 | 1.63 | Superiority or Other |
| Myalgia |
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| Hepatic function abnormal |
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| Gamma-glutamyltransferase increased |
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| Alanine aminotransferase increased |
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Treatment was included in the model as fixed effects, baseline hsCRP as covariate. |
| 0.939 |
| LS Mean Difference |
| 0.01 |
| Standard Error of the Mean |
| 0.13 |
| 2-Sided |
| 90 |
| -0.21 |
| 0.23 |
| Superiority or Other |
| ANCOVA | Treatment was included in the model as fixed effects, baseline hsCRP as covariate. | 0.296 | LS Mean Difference | 0.14 | Standard Error of the Mean | 0.13 | 2-Sided | 90 | -0.08 | 0.36 | Superiority or Other |
| ANCOVA | Treatment was included in the model as fixed effects, baseline hsCRP as covariate. | 0.181 | LS Mean Difference | 0.18 | Standard Error of the Mean | 0.13 | 2-Sided | 90 | -0.04 | 0.40 | Superiority or Other |
|
| 8 Weeks |
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| 12 Weeks |
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| Mixed Models Analysis |
Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. |
| <0.001 |
The P-value is for percent change from baseline in plasma CETP activity at Week 4. |
| LS Mean Difference |
| -76.93 |
| Standard Error of the Mean |
| 6.02 |
| 2-Sided |
| 90 |
| -86.89 |
| -66.97 |
| Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for percent change from baseline in plasma CETP activity at Week 4. | LS Mean Difference | -90.81 | Standard Error of the Mean | 6.08 | 2-Sided | 90 | -100.87 | -80.75 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for percent change from baseline in plasma CETP activity at Week 4. | LS Mean Difference | -67.25 | Standard Error of the Mean | 5.96 | 2-Sided | 90 | -77.12 | -57.39 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for percent change from baseline in plasma CETP activity at Week 8. | LS Mean Difference | -42.60 | Standard Error of the Mean | 6.21 | 2-Sided | 90 | -52.88 | -32.33 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for percent change from baseline in plasma CETP activity at Week 8. | LS Mean Difference | -78.93 | Standard Error of the Mean | 6.17 | 2-Sided | 90 | -89.15 | -68.71 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for percent change from baseline in plasma CETP activity at Week 8. | LS Mean Difference | -93.67 | Standard Error of the Mean | 6.29 | 2-Sided | 90 | -104.08 | -83.26 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for percent change from baseline in plasma CETP activity at Week 8. | LS Mean Difference | -75.01 | Standard Error of the Mean | 6.31 | 2-Sided | 90 | -85.46 | -64.57 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for percent change from baseline in plasma CETP activity at Week 12. | LS Mean Difference | -50.28 | Standard Error of the Mean | 4.98 | 2-Sided | 90 | -58.53 | -42.04 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for percent change from baseline in plasma CETP activity at Week 12. | LS Mean Difference | -83.07 | Standard Error of the Mean | 4.98 | 2-Sided | 90 | -91.32 | -74.83 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for percent change from baseline in plasma CETP activity at Week 12. | LS Mean Difference | -94.51 | Standard Error of the Mean | 5.08 | 2-Sided | 90 | -102.92 | -86.10 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for percent change from baseline in plasma CETP activity at Week 12. | LS Mean Difference | -67.68 | Standard Error of the Mean | 5.15 | 2-Sided | 90 | -76.20 | -59.16 | Superiority or Other |
|
| 8 weeks |
|
|
| 12 weeks |
|
|
| Mixed Models Analysis |
Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. |
| <0.001 |
The P-value is for change from baseline in plasma CETP mass at Week 4. |
| LS Mean Difference |
| 3.06 |
| Standard Error of the Mean |
| 0.25 |
| 2-Sided |
| 90 |
| 2.65 |
| 3.48 |
| Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for change from baseline in plasma CETP mass at Week 4. | LS Mean Difference | 3.46 | Standard Error of the Mean | 0.25 | 2-Sided | 90 | 3.04 | 3.88 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for change from baseline in plasma CETP mass at Week 4. | LS Mean Difference | 2.22 | Standard Error of the Mean | 0.25 | 2-Sided | 90 | 1.81 | 2.63 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for change from baseline in plasma CETP mass at Week 8. | LS Mean Difference | 1.88 | Standard Error of the Mean | 0.29 | 2-Sided | 90 | 1.40 | 2.36 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for change from baseline in plasma CETP mass at Week 8. | LS Mean Difference | 2.99 | Standard Error of the Mean | 0.29 | 2-Sided | 90 | 2.51 | 3.47 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for change from baseline in plasma CETP mass at Week 8. | LS Mean Difference | 3.92 | Standard Error of the Mean | 0.30 | 2-Sided | 90 | 3.42 | 4.41 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for change from baseline in plasma CETP mass at Week 8. | LS Mean Difference | 2.04 | Standard Error of the Mean | 0.29 | 2-Sided | 90 | 1.56 | 2.52 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for change from baseline in plasma CETP mass at Week 12. | LS Mean Difference | 1.82 | Standard Error of the Mean | 0.29 | 2-Sided | 90 | 1.34 | 2.31 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for change from baseline in plasma CETP mass at Week 12. | LS Mean Difference | 2.83 | Standard Error of the Mean | 0.29 | 2-Sided | 90 | 2.34 | 3.31 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for change from baseline in plasma CETP mass at Week 12. | LS Mean Difference | 3.24 | Standard Error of the Mean | 0.30 | 2-Sided | 90 | 2.74 | 3.73 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for change from baseline in plasma CETP mass at Week 12. | LS Mean Difference | 2.14 | Standard Error of the Mean | 0.29 | 2-Sided | 90 | 1.65 | 2.63 | Superiority or Other |
| LDL-C |
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| Comparisons between LY2484595 and Placebo were the primary focus for this endpoint. | Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for percent change from baseline in HDL-C at Week 12. | LS Mean Difference | 115.36 | Standard Error of the Mean | 12.55 | 2-Sided | 90 | 94.58 | 136.14 | Superiority or Other |
| Comparisons between LY2484595 and Placebo were the primary focus for this endpoint. | Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for percent change from baseline in HDL-C at Week 12. | LS Mean Difference | 135.57 | Standard Error of the Mean | 12.72 | 2-Sided | 90 | 114.50 | 156.63 | Superiority or Other |
| Comparisons between LY2484595 and Placebo were the primary focus for this endpoint. | Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | 0.002 | The P-value is for percent change from baseline in LDL-C at Week 12. | LS Mean Difference | -15.47 | Standard Error of the Mean | 4.85 | 2-Sided | 90 | -23.50 | -7.43 | Superiority or Other |
| Comparisons between LY2484595 and Placebo were the primary focus for this endpoint. | Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for percent change from baseline in LDL-C at Week 12. | LS Mean Difference | -23.37 | Standard Error of the Mean | 4.83 | 2-Sided | 90 | -31.37 | -15.38 | Superiority or Other |
| Comparisons between LY2484595 and Placebo were the primary focus for this endpoint. | Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for percent change from baseline in LDL-C at Week 12. | LS Mean Difference | -22.19 | Standard Error of the Mean | 4.91 | 2-Sided | 90 | -30.32 | -14.06 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | <0.001 | The P-value is for percent change from baseline in HDL-C at Week 12. | LS Mean Difference | 103.25 | Standard Error of the Mean | 12.64 | 2-Sided | 90 | 82.32 | 124.18 | Superiority or Other |
| Mixed Models Analysis | Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate. | 0.003 | The P-value is for percent change from baseline in LDL-C at Week 12. | LS Mean Difference | -14.63 | Standard Error of the Mean | 4.88 | 2-Sided | 90 | -22.72 | -6.55 | Superiority or Other |