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This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Placebo Comparator |
| |
| Treatment B | Experimental |
| |
| Treatment C | Experimental |
| |
| Treatment D | Experimental |
| |
| Treatment E | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | Intravenous placebo monthly during treatment phase. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 | Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. | Baseline, Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Day 29, 57, 85 | |
| Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. | Baseline, Day 29, 57, 71, 85, 99, 127, 141 |
| Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 |
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 |
|---|---|---|---|---|---|---|
| Orange County Research Center | Tustin | California | 92780 | United States | ||
| Diablo Clinical Research, Inc. |
| 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. | |
| 29037448 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| FG001 | PF-04950615 0.25 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Statin |
| Drug |
Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET. |
|
| PF-04950615 (RN316) | Biological | Intravenous 10mg/mL based on weight monthly during treatment phase. |
|
| Statin | Drug | Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET. |
|
| PF-04950615 (RN316) | Biological | Intravenous 10mg/mL based on weight monthly during treatment phase. |
|
| Statin | Drug | Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET. |
|
| PF-04950615 (RN316) | Biological | Intravenous 10mg/mL based on weight monthly during treatment phase. |
|
| Satin | Drug | Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET. |
|
| PF-04950615 (RN316) | Biological | Intravenous 10mg/mL based on weight monthly during treatment phase. |
|
| Statin | Drug | Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET. |
|
| Day 29, 57, 85 |
| Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. | Baseline, Day 29, 57, 85 |
| Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. | Baseline, Day 29, 57, 85 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, SAEs and treatment-related TEAEs were reported. | Day 1 up to Day 141 |
| Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Investigator assessed TEAEs as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) or severe (interfered significantly with participant's usual function). TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. | Day 1 up to Day 141 |
| Number of Participants With Clinically Relevant Laboratory Abnormalities | Hematology (hemoglobin[hgb],hematocrit,red blood cell[RBC]<0.8*lower limit of normal[LLN],mean cell[MC] volume,MC hgb,MC hg concentration <0.9*LLN, greater than[>] 1.1*upper limit of normal[ULN], platelet <0.5*LLN,>1.75*ULN, white blood cell[WBC]<0.6*LLN,>1.5*ULN,neutrophil,lymphocyte <0.8*LLN,>1.2*ULN,eosinophil,basophil,monocyte >1.2*ULN);chemistry(total, direct, indirect bilirubin[BR]>1.5*ULN,aspartate aminotransferase[AT],alanine AT,alkaline phosphatase,gamma-glutyl transferase>3.0*ULN,protein,lactate dehydrogenase <0.8*LLN,>1.2*ULN,creatinine,blood urea nitrogen>1.3*ULN,uric acid >1.2*ULN,potassium,chloride,calcium,bicarbonate<0.9*LLN,>1.1*ULN, sodium<0.95*LLN,>1.05*ULN,glucose[GL]<0.6*LLN,>1.5*ULN,amylase,lipase >1.5*ULN,creatinine kinase>2.0*ULN);urinalysis(pH <4.5,>8,specific gravity<1.003 , >1.030, GL,ketone,protein,hgb,BR,nitrite,leukocyte greater than or equal to [>=]1, RBC, WBC >=20);coagulation(prothrombin[PT],PT international ratio,partial thromboplastin time>1.1*ULN). | Day 1 up to Day 141 |
| Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of >=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of >=25 percent (%) for baseline value of >200 millisecond (msec) and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for PR and QRS interval; maximum increase from baseline of >30 to <=60 msec and maximum increase from baseline of >60 msec for QT interval corrected using the Fridericia's formula (QTCF). | Day 1 up to Day 141 |
| Number of Participants With Anti-drug Antibody (ADA) | Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value >=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure. | Day 1 up to Day 141 |
Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. |
| Baseline, Day 29, 57, 71, 85, 99, 127, 141 |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | United States |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | United States |
| In Vivo Clinical Research, Inc. | Doral | Florida | 33166 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Kendall South Medical Center | Miami | Florida | 33185 | United States |
| North Georgia Clinical Research | Woodstock | Georgia | 30189 | United States |
| North Georgia Internal Medicine | Woodstock | Georgia | 30189 | United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| Commonwealth Biomedical Research, LLC | Madisonville | Kentucky | 42431 | United States |
| Maine Research Associates | Auburn | Maine | 04210 | United States |
| Infinity Medical Research | North Dartmouth | Massachusetts | 02747 | United States |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Saint Luke's Lipid and Diabetes Research Center | Kansas City | Missouri | 64111 | United States |
| The Center for Pharmaceutical Research, P.C. | Kansas City | Missouri | 64114 | United States |
| Medex Healthcare Research, Inc. | St Louis | Missouri | 63117 | United States |
| New Mexico Clinical Research & Osteoporosis Center, Incorporated | Albuquerque | New Mexico | 87106 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| PMG Research of Salisbury | Salisbury | North Carolina | 28144 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Oklahoma Cardiovascular Research Group (OCRG) | Oklahoma City | Oklahoma | 73120 | United States |
| Oklahoma Heart Hospital Physicians | Oklahoma City | Oklahoma | 73120 | United States |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| Translational Research Center | Philadelphia | Pennsylvania | 19104 | United States |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States |
| New Orleans Center for Clinical Research | Knoxville | Tennessee | 37920 | United States |
| Volunteer Research Group | Knoxville | Tennessee | 37920 | United States |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | United States |
| Paragon Research Center, LLC | San Antonio | Texas | 78205 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| San Antonio Preventive & Diagnostic Medicine, PA | San Antonio | Texas | 78229 | United States |
| National Clinical Research - Norfolk, Inc. | Norfolk | Virginia | 23502 | United States |
| National Clinical Research - Richmond, Inc. | Richmond | Virginia | 23294 | United States |
| The Medical Arts Health Research Group | Kelowna | British Columbia | V1Y 3G8 | Canada |
| Q & T Research Chicoutimi | Chicoutimi | Quebec | G7H 7Y8 | Canada |
| Centre de Recherche Clinique de Laval | Laval | Quebec | H7T 2P5 | Canada |
| Diex Research Montreal Inc. | Montreal | Quebec | H4N 3C5 | Canada |
| Clinique des Maladies Lipidiques de Quebec Inc. | Québec | Quebec | G1V 4M6 | Canada |
| Diex Research Sherbrooke Inc. | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Wan H, Gumbiner B, Joh T, Riel T, Udata C, Forgues P, Garzone PD. Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition with Bococizumab on Lipoprotein Particles in Hypercholesterolemic Subjects. Clin Ther. 2017 Nov;39(11):2243-2259.e5. doi: 10.1016/j.clinthera.2017.09.009. Epub 2017 Oct 14. |
| 28181260 | Derived | Udata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development. J Clin Pharmacol. 2017 Jul;57(7):855-864. doi: 10.1002/jcph.867. Epub 2017 Feb 9. |
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| FG002 | PF-04950615 1.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| FG003 | PF-04950615 3.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| FG004 | PF-04950615 6.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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|
Safety analysis population included all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| BG001 | PF-04950615 0.25 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| BG002 | PF-04950615 1.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| BG003 | PF-04950615 3.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| BG004 | PF-04950615 6.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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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 Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 | Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. | Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. Here 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 85 |
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| Secondary | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL) | Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. 'N' = participants who were evaluable for this outcome measure and 'number analyzed' = participants who were evaluable at specified time points for each arm. | Posted | Number | percentage of participants | Day 29, 57, 85 |
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| Secondary | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. 'N' = participants who were evaluable for this outcome measure and 'number analyzed' = participants who were evaluable at specified time points for each arm. | Posted | Number | percentage of participants | Day 29, 57, 85 |
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| Secondary | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. | Efficacy analysis set. 'number analyzed' = participants who were evaluable at specified time points for each arm. Results for change at Day 85 in lipid parameters ApoB and ApoA1 were not reported because data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol. | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dL) | Baseline, Day 29, 57, 85 |
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| Secondary | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. | Efficacy analysis set. 'number analyzed' = participants who were evaluable at specified time points for each arm. Results for percent change at Day 85 for ApoB and ApoA1 were not reported because data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 29, 57, 85 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, SAEs and treatment-related TEAEs were reported. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | participants | Day 1 up to Day 141 |
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| Secondary | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Investigator assessed TEAEs as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) or severe (interfered significantly with participant's usual function). TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | adverse events | Day 1 up to Day 141 |
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| Secondary | Number of Participants With Clinically Relevant Laboratory Abnormalities | Hematology (hemoglobin[hgb],hematocrit,red blood cell[RBC]<0.8*lower limit of normal[LLN],mean cell[MC] volume,MC hgb,MC hg concentration <0.9*LLN, greater than[>] 1.1*upper limit of normal[ULN], platelet <0.5*LLN,>1.75*ULN, white blood cell[WBC]<0.6*LLN,>1.5*ULN,neutrophil,lymphocyte <0.8*LLN,>1.2*ULN,eosinophil,basophil,monocyte >1.2*ULN);chemistry(total, direct, indirect bilirubin[BR]>1.5*ULN,aspartate aminotransferase[AT],alanine AT,alkaline phosphatase,gamma-glutyl transferase>3.0*ULN,protein,lactate dehydrogenase <0.8*LLN,>1.2*ULN,creatinine,blood urea nitrogen>1.3*ULN,uric acid >1.2*ULN,potassium,chloride,calcium,bicarbonate<0.9*LLN,>1.1*ULN, sodium<0.95*LLN,>1.05*ULN,glucose[GL]<0.6*LLN,>1.5*ULN,amylase,lipase >1.5*ULN,creatinine kinase>2.0*ULN);urinalysis(pH <4.5,>8,specific gravity<1.003 , >1.030, GL,ketone,protein,hgb,BR,nitrite,leukocyte greater than or equal to [>=]1, RBC, WBC >=20);coagulation(prothrombin[PT],PT international ratio,partial thromboplastin time>1.1*ULN). | Safety analysis set included all participants who received at least 1 dose of study drug. Here 'N' signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Day 1 up to Day 141 |
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| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of >=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of >=25 percent (%) for baseline value of >200 millisecond (msec) and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for PR and QRS interval; maximum increase from baseline of >30 to <=60 msec and maximum increase from baseline of >60 msec for QT interval corrected using the Fridericia's formula (QTCF). | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | participants | Day 1 up to Day 141 |
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| Secondary | Number of Participants With Anti-drug Antibody (ADA) | Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value >=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure. | Analysis set included all participants who received at least 1 dose of PF-04950615 (RN316). | Posted | Number | participants | Day 1 up to Day 141 |
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| Other Pre-specified | Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. | Efficacy analysis set. 'number analyzed' = participants who were evaluable for specified time points for each arm. Results for change at Day 85 in Lp(a) was not reported because data was not collected for Lp(a) at Day 85 due to an inadvertent omission in the protocol. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 29, 57, 71, 85, 99, 127, 141 |
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| Other Pre-specified | Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 | Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. | Efficacy analysis set. 'number analyzed' = participants who were evaluable for specified time points for each arm. Results for percent change at Day 85 in Lp(a) was not reported because data was not collected for Lp(a) at Day 85 due to an inadvertent omission in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 29, 57, 71, 85, 99, 127, 141 |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant or one participant may have experienced both a serious and nonserious event during the study. Safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. | 0 | 19 | 14 | 19 | ||
| EG001 | PF-04950615 0.25 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. | 1 | 17 | 13 | 17 | ||
| EG002 | PF-04950615 1.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. | 1 | 18 | 13 | 18 | ||
| EG003 | PF-04950615 3.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. | 0 | 19 | 11 | 19 | ||
| EG004 | PF-04950615 6.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. | 0 | 17 | 11 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sinus arrest | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Ear disorder | Ear and labyrinth disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Polyp colorectal | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Infusion site phlebitis | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hyporeflexia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Migraine | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Paraesthesia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sinus headache | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Syncope | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rhinitis seasonal | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
|
Due to an inadvertent omission in the protocol at Day 85, presented limitations in the assessment of treatment effect on ApoA1, ApoB and Lp(a) for Day 85.
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 |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| C000598888 | bococizumab |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
Not provided
Not provided
| Male |
|
Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline. |
| ANCOVA |
| 0.8080 |
| LS Mean Difference |
| -2.30 |
| Standard Error of the Mean |
| 9.422 |
| 2-Sided |
| 95 |
| -21.08 |
| 16.49 |
| Superiority or Other |
| Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline. | ANCOVA | 0.0001 | LS Mean Difference | -37.72 | Standard Error of the Mean | 9.404 | 2-Sided | 95 | -56.47 | -18.97 | Superiority or Other |
| Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline. | ANCOVA | <0.0001 | LS Mean Difference | -49.11 | Standard Error of the Mean | 9.514 | 2-Sided | 95 | -68.08 | -30.14 | Superiority or Other |
| OG003 | PF-04950615 3.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG004 | PF-04950615 6.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
|
|
|
| OG003 | PF-04950615 3.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG004 | PF-04950615 6.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
|
|
|
| PF-04950615 1.0 mg/kg |
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG003 | PF-04950615 3.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG004 | PF-04950615 6.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
|
|
| PF-04950615 1.0 mg/kg |
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG003 | PF-04950615 3.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG004 | PF-04950615 6.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
|
|
| OG002 | PF-04950615 1.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG003 | PF-04950615 3.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG004 | PF-04950615 6.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
|
|
Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG003 | PF-04950615 3.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG004 | PF-04950615 6.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
|
|
| OG001 |
| PF-04950615 0.25 mg/kg |
Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG002 | PF-04950615 1.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG003 | PF-04950615 3.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG004 | PF-04950615 6.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
|
|
| OG002 | PF-04950615 1.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG003 | PF-04950615 3.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG004 | PF-04950615 6.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
|
|
Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
| OG003 | PF-04950615 6.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
|
|
| OG003 | PF-04950615 3.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG004 | PF-04950615 6.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
|
|
| OG003 | PF-04950615 3.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
| OG004 | PF-04950615 6.0 mg/kg | Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141. |
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