A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia

• Status: Completed
• Trial end date: 2016-04-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy 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.

• Heterozygous familial hypercholesterolemia.

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.