Overview

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.