A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins
Status: | Completed |
---|---|
Conditions: | High Cholesterol |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/10/2017 |
Start Date: | June 2011 |
End Date: | June 2012 |
A Phase 2, Double-blind, Placebo-controlled, Randomized Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Multiple Intravenous Doses In Hypercholesterolemic Subjects On Maximum Dose Of Atorvastatin Or Rosuvastatin.
PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this
study to evaluate if it can lower LDL cholesterol.
study to evaluate if it can lower LDL cholesterol.
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.
We found this trial at
30
sites
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Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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