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

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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.


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
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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404 Memorial Dr.
Greer, South Carolina 29651
864-848-9293
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Atlanta, Georgia 30309
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Clearwater, Florida 33756
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Duncansville, Pennsylvania 16635
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12792 Valley View Street
Garden Grove, California 92845
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Garden Grove, California 92845
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Kansas City, Missouri 64111
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Kelowna, British Columbia
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Kingsport, Tennessee 37660
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Long Beach, California 90806
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Miami, Florida 33175
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Oklahoma City, Oklahoma 73120
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Oklahoma City, Oklahoma 73120
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Oklahoma City, Oklahoma 73120
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Orem, Utah 84058
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Overland Park, Kansas 66209
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Overland Park, Kansas 64116
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Overland Park, Kansas 23112
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Raleigh, North Carolina 27612
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Saint Louis, Missouri 63128
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Tomball, Texas 77375
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Wildomar, California 92595
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