A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Bococizumab

Criteria

Inclusion Criteria:

• Body Mass Index (BMI) of 18.5 to 40 kg/m2

• On a stable maximum daily dose of a statin, defined as atorvastatin 80 mg or rosuvastatin 40 mg for a minimum of 45 days prior to Day 1.

• Lipids meet the following criteria twice during screening period:

• Fasting LDL C = or > 80 mg/dL;

• Fasting TG < 400 mg/dL.

Exclusion Criteria:

• History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past year.

• Poorly controlled type 1 or type 2 diabetes mellitus.

• Poorly controlled hypertension.

• Fasting triglycerides > 400 mg/dL

• 12 lead ECG demonstrating QTcFF >455 msec at screening.