Clinical trial NCT02135029: Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins
Official title: A Phase 3, Double-blind, Double-dummy, Randomized, Placebo And Active Controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Dyslipidemia Who Are Intolerant To Statins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Keywords: Hyperlipidemia
statin intolerance
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-05-09
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24
timeFrame: Baseline, Week 24
measure: Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting Triglycerides (TG) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12
timeFrame: Baseline, Week 12
measure: Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24
timeFrame: Baseline, Week 12, 24
measure: Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24
timeFrame: Baseline, Week 12, 24
measure: 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
timeFrame: Week 12, 24
measure: 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
timeFrame: Week 12, 24
measure: Plasma PF-04950615 Concentrations at Weeks 12 and 24
timeFrame: Week 12 and 24
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
timeFrame: Baseline (Day 1) up to Week 30
measure: Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
timeFrame: Baseline up to Week 30
measure: Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively
timeFrame: Week 4, 12, 24 and 30 (Follow-up)
measure: Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations
timeFrame: Baseline (Day 1) up to Week 30
Other outcomes:
Locations:
city: Denver
country: United States
facility: Creekside Endocrine Associates, PC
state: Colorado
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Lakeland
country: United States
facility: Watson Clinic Center for Research, Inc. (for Drug Shipment only)
state: Florida
city: Miami
country: United States
facility: Cardiovascular Research Center Of South Florida
state: Florida
city: Ponte Vedra
country: United States
facility: St. Johns Center for Clinical Research
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Evanston
country: United States
facility: NorthShore University HealthSystem - Evanston Hospital
state: Illinois
city: Mokena
country: United States
facility: Health Care Centers of Illinois Mokena Medical Commons
state: Illinois
city: Normal
country: United States
facility: Advocate Medical Group Cardiology
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Medical Group Midwest Heart Specialists
state: Illinois
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative (Administrative)
state: Illinois
city: Springfield
country: United States
facility: Prairie Heart Institute
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Iowa City
country: United States
facility: The University of Iowa - College of Public Health - Preventive Intervention Center
state: Iowa
city: West Des Moines
country: United States
facility: The Iowa Clinic, PC
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Metairie
country: United States
facility: Crescent City Clinical Research Center
state: Louisiana
city: Minneapolis
country: United States
facility: Allina Health System, dba Abbott Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Dayton
country: United States
facility: Dayton Heart Center
state: Ohio
city: Philadelphia
country: United States
facility: Clinical and Translational Research Center, Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Cardiologists, Ltd.
state: Pennsylvania
city: Bristol
country: United States
facility: PMG Research of Bristol
state: Tennessee
city: Knoxville
country: United States
facility: PMG Research of Knoxville, LLC
state: Tennessee
city: Fort Sam Houston
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Houston
country: United States
facility: Office of Michelle Zaniewski MD., PA.
state: Texas
city: Layton
country: United States
facility: Utah Cardiology, P.C.
state: Utah
city: Orem
country: United States
facility: Aspen Clinical Research LLC
state: Utah
city: Kelowna
country: Canada
facility: The Medical Arts Health Research Group
state: British Columbia
city: Corunna
country: Canada
facility: Corunna Medical Research Centre
state: Ontario
city: Oshawa
country: Canada
facility: The Office of Dr. James Cha
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Cardiology Clinical Trials
state: Ontario
city: Woodstock
country: Canada
facility: Devonshire Clinical Research Inc.
state: Ontario
city: Chicoutimi
country: Canada
facility: Ecogene-21
state: Quebec
city: Mirabel
country: Canada
facility: Omnispec clinical research inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Quebec
country: Canada
facility: Clinique des maladies lipidiques de Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.