Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins
NCT ID: NCT02135029
Last Updated: 2017-12-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
184 participants
INTERVENTIONAL
2014-06-30
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bococizumab (PF-04950615;RN316)
Bococizumab (PF-04950615;RN316)
Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks by subcutaneous injection for 24 weeks
Atorvastatin
Atorvastatin
Atorvastatin PO QD
Placebo
Placebo for Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks by subcutaneous injection for 24 weeks
Placebo for atorvastatin
PO QD
Interventions
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Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks by subcutaneous injection for 24 weeks
Atorvastatin
Atorvastatin PO QD
Placebo for Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks by subcutaneous injection for 24 weeks
Placebo for atorvastatin
PO QD
Eligibility Criteria
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Inclusion Criteria
* Statin Intolerant
* Fasting LDL-C \> = 70 mg/dL Fasting TG \< = 400 mg/dL
Exclusion Criteria
* Cardiovascular or cerebrovascular event or procedure within 90 days
* Severe or life-threatening adverse events with past use of statins
* Poorly controlled hypertension
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Advocate Medical Group Midwest Heart Specialists
Park Ridge, Illinois, United States
Prairie Education & Research Cooperative (Administrative)
Springfield, Illinois, United States
Prairie Heart Institute
Springfield, Illinois, United States
St. John's Hospital
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
University of Kansas Medical Center
Kansas City, Kansas, United States
Crescent City Clinical Research Center
Metairie, Louisiana, United States
Allina Health System, dba Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 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
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Berks Cardiologists, Ltd.
Wyomissing, Pennsylvania, United States
PMG Research of Bristol
Bristol, Tennessee, United States
PMG Research of Knoxville, LLC
Knoxville, Tennessee, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States
Office of Michelle Zaniewski MD., PA.
Houston, Texas, 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
Corunna Medical Research Centre
Corunna, Ontario, Canada
The Office of Dr. James Cha
Oshawa, Ontario, Canada
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, Canada
Devonshire Clinical Research Inc.
Woodstock, Ontario, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
Omnispec clinical research inc.
Mirabel, Quebec, Canada
Clinique des maladies lipidiques de Quebec
Québec, Quebec, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Countries
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References
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Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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STATIN INTOLERANT
Identifier Type: -
Identifier Source: secondary_id
SPIRE-SI
Identifier Type: OTHER
Identifier Source: secondary_id
B1481030
Identifier Type: -
Identifier Source: org_study_id