Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With 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, 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.

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

Details

• Lead Sponsor: Pfizer
• Treatments: Bococizumab

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.

Exclusion Criteria:

• Pregnant or breastfeeding females.

• Cardiovascular or cerebrovascular event of procedures during the past 30 days.

• Congestive heart failure NYHA class IV.

• Poorly controlled hypertension.