Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins
- Conditions
- Hyperlipidemia
- Interventions
- Other: Placebo for Bococizumab (PF-04950615;RN316)Other: Placebo for atorvastatin
- Registration Number
- NCT02135029
- Lead Sponsor
- Pfizer
- Brief Summary
This study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are statin intolerant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
- Hyperlipidemia
- Statin Intolerant
- Fasting LDL-C > = 70 mg/dL Fasting TG < = 400 mg/dL
- Pregnant or breastfeeding females
- Cardiovascular or cerebrovascular event or procedure within 90 days
- Severe or life-threatening adverse events with past use of statins
- Poorly controlled hypertension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bococizumab (PF-04950615;RN316) Bococizumab (PF-04950615;RN316) Bococizumab (PF-04950615;RN316) Atorvastatin Atorvastatin - Placebo Placebo for Bococizumab (PF-04950615;RN316) - Placebo Placebo for atorvastatin -
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline, Week 12
- Secondary Outcome Measures
Name Time Method Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24 Baseline, Week 12, 24 Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24 Baseline, Week 12, 24 Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24 Baseline, Week 12, 24 Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24 Baseline, Week 12, 24 Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24 Baseline, Week 12, 24 Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24 Baseline, Week 12, 24 Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24 Baseline, Week 12, 24 Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 Baseline, Week 24 Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24 Baseline, Week 12, 24 Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24 Baseline, Week 12, 24 Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24 Baseline, Week 12, 24 Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24 Baseline, Week 12, 24 Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline, Week 12 Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 Baseline, Week 12 Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 Baseline, Week 12 Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 Baseline, Week 12 Absolute Change From Baseline in Fasting Triglycerides (TG) at Week 12 Baseline, Week 12 Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12 Baseline, Week 12 Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12 Baseline, Week 12 Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 Week 12, 24 Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24 Week 12, 24 Plasma PF-04950615 Concentrations at Weeks 12 and 24 Week 12 and 24 Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.4 micrograms per milliliter \[mcg/mL\]) to zero. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.
Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations Baseline (Day 1) up to Week 30 Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb) Baseline up to Week 30 Participants with at least one positive ADA titer greater than or equal to (\>=) 6.23 or positive nAb titer \>=4.32 were reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.
Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively Week 4, 12, 24 and 30 (Follow-up) Titer levels of participants who tested positive for ADA and nAb are reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.
Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations Baseline (Day 1) up to Week 30
Trial Locations
- Locations (40)
PMG Research of Knoxville, LLC
🇺🇸Knoxville, Tennessee, United States
Watson Clinic Center for Research, Inc. (for Drug Shipment only)
🇺🇸Lakeland, Florida, United States
Cardiovascular Research Center Of South Florida
🇺🇸Miami, Florida, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States
PMG Research of Bristol
🇺🇸Bristol, Tennessee, United States
Office of Michelle Zaniewski MD., PA.
🇺🇸Houston, Texas, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
St. Johns Center for Clinical Research
🇺🇸Ponte Vedra, Florida, United States
Health Care Centers of Illinois Mokena Medical Commons
🇺🇸Mokena, Illinois, United States
NorthShore University HealthSystem - Evanston Hospital
🇺🇸Evanston, Illinois, United States
Advocate Medical Group Cardiology
🇺🇸Normal, Illinois, United States
Prairie Education & Research Cooperative (Administrative)
🇺🇸Springfield, Illinois, United States
Advocate Medical Group Midwest Heart Specialists
🇺🇸Park Ridge, Illinois, United States
Prairie Heart Institute
🇺🇸Springfield, Illinois, United States
The University of Iowa - College of Public Health - Preventive Intervention Center
🇺🇸Iowa City, Iowa, United States
The Iowa Clinic, PC
🇺🇸West Des Moines, Iowa, United States
St. John's Hospital
🇺🇸Springfield, Illinois, United States
Crescent City Clinical Research Center
🇺🇸Metairie, Louisiana, United States
PMG Research of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States
Dayton Heart Center
🇺🇸Dayton, Ohio, United States
Clinical and Translational Research Center, Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Berks Cardiologists, Ltd.
🇺🇸Wyomissing, Pennsylvania, United States
Utah Cardiology, P.C.
🇺🇸Layton, Utah, United States
Aspen Clinical Research LLC
🇺🇸Orem, Utah, United States
The Medical Arts Health Research Group
🇨🇦Kelowna, British Columbia, Canada
Devonshire Clinical Research Inc.
🇨🇦Woodstock, Ontario, Canada
San Antonio Military Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Corunna Medical Research Centre
🇨🇦Corunna, Ontario, Canada
Diex Research Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
The Office of Dr. James Cha
🇨🇦Oshawa, Ontario, Canada
Kawartha Cardiology Clinical Trials
🇨🇦Peterborough, Ontario, Canada
Omnispec clinical research inc.
🇨🇦Mirabel, Quebec, Canada
Ecogene-21
🇨🇦Chicoutimi, Quebec, Canada
Clinique des maladies lipidiques de Quebec
🇨🇦Quebec, Canada
Creekside Endocrine Associates, PC
🇺🇸Denver, Colorado, United States
Allina Health System, dba Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States