Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
(SPIRE-HR Trial)
Recruiting at102 trial 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
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University