Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins

Phase 3

Completed

• Conditions: Hyperlipidemia
• Interventions: Drug: Bococizumab (PF-04950615;RN316); Drug: Atorvastatin; 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

Study Timeline

• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-09
• Study Start: 2014-06
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Disposition First Submitted: 2017-03-07
• Disposition First Submitted QC: 2017-03-07
• Disposition First Posted: 2017-03-08
• Results First Submitted: 2017-10-02
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-17
• Last Update Submitted: 2017-11-17
• Results First Posted: 2017-12-14
• Last Update Posted: 2017-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

• Hyperlipidemia
• Statin Intolerant
• Fasting LDL-C > = 70 mg/dL Fasting TG < = 400 mg/dL

Exclusion Criteria

• 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
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
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
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
Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24	Baseline, Week 12, 24
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)

Creekside Endocrine Associates, PC; 🇺🇸 Denver, Colorado, United States

Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, 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

St. Johns Center for Clinical Research; 🇺🇸 Ponte Vedra, Florida, United States

Progressive Medical Research; 🇺🇸 Port Orange, Florida, United States

East-West Medical Research Institute; 🇺🇸 Honolulu, Hawaii, United States

NorthShore University HealthSystem - Evanston Hospital; 🇺🇸 Evanston, Illinois, United States

Health Care Centers of Illinois Mokena Medical Commons; 🇺🇸 Mokena, Illinois, United States

Advocate Medical Group Cardiology; 🇺🇸 Normal, Illinois, United States

Scroll for more (30 remaining)