Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

Phase 3

Completed

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

• Registration Number: NCT01968954
• Lead Sponsor: Pfizer

Brief Summary

This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-21
• Study First Submitted QC: 2013-10-21
• Study First Posted: 2013-10-24
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-03
• Results First Submitted: 2017-04-06
• Results First Submitted QC: 2017-04-06
• Last Update Submitted: 2017-04-06
• Results First Posted: 2017-05-17
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 711

Inclusion Criteria

• Treated with a statin.
• Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL.
• High or very high risk of incurring a cardiovascular event.

Exclusion Criteria

• Pregnant or breastfeeding females.
• Cardiovascular or cerebrovascular event of procedures during the past 30 days.
• Congestive heart failure NYHA class IV.
• Poorly controlled hypertension.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Bococizumab (PF-04950615;RN316)	Bococizumab (PF-04950615;RN316)	-

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12	Baseline, Week 12

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia	Baseline, Week 12	Participants with primary hyperlipidemia are defined as participants with triglycerides (TG) level less than (\<) 200 milligram per decilitre (mg/dL) (2.26 millimoles per litre \[mmol/L\]) at pre-randomization.
Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia	Baseline, Week 12	Participants with mixed dyslipidemia are defined as TG level greater than or equal to (\>=) 200 mg/dL (2.26 mmol/L) at pre-randomization.
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52	Baseline, Week 24, 52
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off	Baseline, Week 24, 52	Percent change from baseline in fasting LDL-C among participants with TG cut-off of \<200 mg/dL and \>=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.
Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off	Baseline, Week 12	Absolute change from baseline among participants with TG cut-off of \<200 mg/dL and \>=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.
Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52	Baseline, Week 12, 24, 52
Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Litre) at Week 12, 24 and 52	Week 12, 24 and 52
Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Litre) at Week 12, 24 and 52	Week 12, 24 and 52
Plasma PF-04950615 Concentrations at Week 12, 24 and 52	Week 12, 24, 52
Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions	Baseline up to the end of study (up to 58 weeks)	Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, pain, pruritus and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)	Baseline up to the end of study (up to 58 weeks)	Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer \>=6.23 were considered to be ADA positive and participants with their nAb titer \>=1.58 were considered to be nAb positive.

Trial Locations

Locations (103)

Achieve Clinical Research, LLC; 🇺🇸 Birmingham, Alabama, United States

Cardiovascular Associates of the Southeast, LLC; 🇺🇸 Birmingham, Alabama, United States

Southwest Heart Group; 🇺🇸 Tucson, Arizona, United States

ARA-Arizona Research Associates; 🇺🇸 Tucson, Arizona, United States

Diagnamics, Inc.; 🇺🇸 Encinitas, California, United States

Encompass Clinical Research North Coast; 🇺🇸 Encinitas, California, United States

MD Studies, Inc.; 🇺🇸 Fountain Valley, California, United States

Alliance Research Centers; 🇺🇸 Laguna Hills, California, United States

Prime Care Clinical Research; 🇺🇸 Laguna Hills, California, United States

Providence Clinical Research; 🇺🇸 North Hollywood, California, United States

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