Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Pfizer
• Treatments: Atorvastatin; Atorvastatin Calcium; Bococizumab

Criteria

Inclusion Criteria:

• Hyperlipidemia

• Statin Intolerant

• Fasting LDL-C > = 70 mg/dL Fasting TG < = 400 mg/dL

Exclusion Criteria:

• 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