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

Last updated on March 14, 2019

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Study Location
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolemia, Dyslipidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT01350141
Pfizer
Completed
A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins

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