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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypercholesterolemia, Dyslipidemia

In brief

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

Key facts

Study ID

NCT01350141

Run by

Pfizer

People needed

46

Starts

2011-06-01

Expected to finish

2012-06-01

Last updated by the study team

2017-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Achieve Clinical Research, LLC — Birmingham, Alabama, United States
• Advance Outcome Management, Inc. — Garden Grove, California, United States
• Collaborative Neuroscience Network, Inc — Garden Grove, California, United States
• Collaborative Neuroscience Network, Inc. — Long Beach, California, United States
• Elite Clinical Trials, Inc. — Wildomar, California, United States
• Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Kendall South Medical Center, Inc. — Miami, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• Atlanta Diabetes Associates — Atlanta, Georgia, United States
• Midwest Cardiology Associates — Overland Park, Kansas, United States
• Stark Pharmacy — Overland Park, Kansas, United States
• Vince and Associates Clinical Research — Overland Park, Kansas, United States
• Saint Luke's Hospital — Kansas City, Missouri, United States
• Saint Luke's Lipid and Diabetes Research Center — Kansas City, Missouri, United States
• Advance Clinical Research — St Louis, Missouri, United States
• Wake Internal Medicine Consultants, Inc. — Raleigh, North Carolina, United States
• Wake Research Associates, LLC — Raleigh, North Carolina, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• Oklahoma Cardiovascular Research Group — Oklahoma City, Oklahoma, United States
• Oklahoma Heart Hospital Physicians — Oklahoma City, Oklahoma, United States
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• DeGarmo Institute of Medical Research — Greer, South Carolina, United States
• Holston Medical Group — Kingsport, Tennessee, United States

Full record on ClinicalTrials.gov

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