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

PHASE3CompletedINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
Hyperlipidemia
Interventions
DRUG

Bococizumab (PF-04950615;RN316)

150 mg every 2 weeks by subcutaneous injection for 24 weeks

DRUG

Atorvastatin

Atorvastatin PO QD

OTHER

Placebo for Bococizumab (PF-04950615;RN316)

150 mg every 2 weeks by subcutaneous injection for 24 weeks

OTHER

Placebo for atorvastatin

PO QD

Trial Locations (40)

19104

Clinical and Translational Research Center, Hospital of the University of Pennsylvania, Philadelphia

Perelman Center for Advanced Medicine, Philadelphia

19610

Berks Cardiologists, Ltd., Wyomissing

28401

PMG Research of Wilmington, LLC, Wilmington

32081

St. Johns Center for Clinical Research, Ponte Vedra

32127

Progressive Medical Research, Port Orange

33173

Cardiovascular Research Center Of South Florida, Miami

33805

Watson Clinic Center for Research, Inc. (for Drug Shipment only), Lakeland

37620

PMG Research of Bristol, Bristol

37912

PMG Research of Knoxville, LLC, Knoxville

45414

Dayton Heart Center, Dayton

50266

The Iowa Clinic, PC, West Des Moines

52242

The University of Iowa - College of Public Health - Preventive Intervention Center, Iowa City

55407

Allina Health System, dba Abbott Northwestern Hospital, Minneapolis

Minneapolis Heart Institute Foundation, Minneapolis

60068

Advocate Medical Group Midwest Heart Specialists, Park Ridge

60201

NorthShore University HealthSystem - Evanston Hospital, Evanston

60448

Health Care Centers of Illinois Mokena Medical Commons, Mokena

61761

Advocate Medical Group Cardiology, Normal

62701

Prairie Education & Research Cooperative (Administrative), Springfield

Prairie Heart Institute, Springfield

62769

St. John's Hospital, Springfield

66160

University of Kansas Medical Center, Kansas City

70006

Crescent City Clinical Research Center, Metairie

77090

Office of Michelle Zaniewski MD., PA., Houston

80209

Creekside Endocrine Associates, PC, Denver

84041

Utah Cardiology, P.C., Layton

84058

Aspen Clinical Research LLC, Orem

96814

East-West Medical Research Institute, Honolulu

06610

Bridgeport Hospital, Bridgeport

78234-6200

San Antonio Military Medical Center, Fort Sam Houston

V1Y 1V6

The Medical Arts Health Research Group, Kelowna

N0N 1G0

Corunna Medical Research Centre, Corunna

L1J 2K1

The Office of Dr. James Cha, Oshawa

K9J 0B2

Kawartha Cardiology Clinical Trials, Peterborough

N4S 5P5

Devonshire Clinical Research Inc., Woodstock

G7H 7K9

Ecogene-21, Chicoutimi

J7J 2K8

Omnispec clinical research inc., Mirabel

G1V 4W2

Clinique des maladies lipidiques de Quebec, Québec

J1H 1Z1

Diex Research Sherbrooke Inc., Sherbrooke

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02135029 - Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins | Biotech Hunter | Biotech Hunter