Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events
(SPIRE-LDL Trial)
Recruiting in Palo Alto (17 mi)
+247 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Pfizer
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
PC
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
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.
Treatment Details
Interventions
- Bococizumab (PF-04950615; RN316) (Monoclonal Antibodies)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bococizumab (PF-04950615; RN316)Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Alia Clinical Research, Inc.Huntington Park, CA
Empire Clinical ResearchUpland, CA
East Coast Institute for Research, LLC at Jacksonville Cardiovascular CenterJacksonville, FL
San Marcus Research Clinic, Inc.Miami, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Trials
4712
Patients Recruited
50,980,000+
Known For
Vaccine Innovations
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