Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events

• Status: Completed
• Trial end date: 2017-07-10
• Target enrollment: 0
• Participant gender: All

Summary

This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Bococizumab

Criteria

Inclusion Criteria:

• Treated with a statin

• Fasting LDL-C >=100 mg/dL and triglyceride <= 400 mg/dL

• High or very high risk of incurring a cardiovascular event

Exclusion Criteria:

• Pregnant or breastfeeding females

• Cardiovascular or cerebrovascular event or procedure within 90 days

• Congestive heart failure NYHA class IV

• Poorly controlled hypertension