Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins
SPIRE-SI
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
3 other identifiers
interventional
184
2 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2014
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2014
CompletedFirst Posted
Study publicly available on registry
May 9, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
December 14, 2017
CompletedDecember 14, 2017
November 1, 2017
1.4 years
May 7, 2014
October 2, 2017
November 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Baseline, Week 12
Secondary Outcomes (26)
Percent Change From Baseline in Fasting Total Cholesterol (TC) 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 Lipoprotein (a) (Lp[a]) 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
- +21 more secondary outcomes
Study Arms (3)
Bococizumab (PF-04950615;RN316)
EXPERIMENTALBococizumab (PF-04950615;RN316)
Atorvastatin
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
150 mg every 2 weeks by subcutaneous injection for 24 weeks
150 mg every 2 weeks by subcutaneous injection for 24 weeks
Eligibility Criteria
You may qualify if:
- Hyperlipidemia
- Statin Intolerant
- Fasting LDL-C \> = 70 mg/dL Fasting TG \< = 400 mg/dL
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (40)
Creekside Endocrine Associates, PC
Denver, Colorado, 80209, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Watson Clinic Center for Research, Inc. (for Drug Shipment only)
Lakeland, Florida, 33805, United States
Cardiovascular Research Center Of South Florida
Miami, Florida, 33173, United States
St. Johns Center for Clinical Research
Ponte Vedra, Florida, 32081, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
NorthShore University HealthSystem - Evanston Hospital
Evanston, Illinois, 60201, United States
Health Care Centers of Illinois Mokena Medical Commons
Mokena, Illinois, 60448, United States
Advocate Medical Group Cardiology
Normal, Illinois, 61761, United States
Advocate Medical Group Midwest Heart Specialists
Park Ridge, Illinois, 60068, United States
Prairie Education & Research Cooperative (Administrative)
Springfield, Illinois, 62701, United States
Prairie Heart Institute
Springfield, Illinois, 62701, United States
St. John's Hospital
Springfield, Illinois, 62769, United States
The University of Iowa - College of Public Health - Preventive Intervention Center
Iowa City, Iowa, 52242, United States
The Iowa Clinic, PC
West Des Moines, Iowa, 50266, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Crescent City Clinical Research Center
Metairie, Louisiana, 70006, United States
Allina Health System, dba Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Dayton Heart Center
Dayton, Ohio, 45414, United States
Clinical and Translational Research Center, Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Berks Cardiologists, Ltd.
Wyomissing, Pennsylvania, 19610, United States
PMG Research of Bristol
Bristol, Tennessee, 37620, United States
PMG Research of Knoxville, LLC
Knoxville, Tennessee, 37912, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234-6200, United States
Office of Michelle Zaniewski MD., PA.
Houston, Texas, 77090, United States
Utah Cardiology, P.C.
Layton, Utah, 84041, United States
Aspen Clinical Research LLC
Orem, Utah, 84058, United States
The Medical Arts Health Research Group
Kelowna, British Columbia, V1Y 1V6, Canada
Corunna Medical Research Centre
Corunna, Ontario, N0N 1G0, Canada
The Office of Dr. James Cha
Oshawa, Ontario, L1J 2K1, Canada
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J 0B2, Canada
Devonshire Clinical Research Inc.
Woodstock, Ontario, N4S 5P5, Canada
Ecogene-21
Chicoutimi, Quebec, G7H 7K9, Canada
Omnispec clinical research inc.
Mirabel, Quebec, J7J 2K8, Canada
Clinique des maladies lipidiques de Quebec
Québec, Quebec, G1V 4W2, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1H 1Z1, Canada
Related Publications (2)
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.
PMID: 37994400DERIVEDRidker 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.
PMID: 28304227DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2014
First Posted
May 9, 2014
Study Start
June 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
December 14, 2017
Results First Posted
December 14, 2017
Record last verified: 2017-11