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Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin

Last updated on March 11, 2019

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Study Location
Premier Research Group, Limited
Peoria, Arizona, 85381 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
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- On stable doses of atorvastatin (40 mg daily) for 45 days prior to Day 1.

- BMI 18.5 to 40 kg/m2 inclusive, and body weight equal or lower than 150 kg.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- History of a cardiovascular event (e.g., MI ) during the past year.

- Poorly controlled Type 1 or Type 2 Diabetes mellitus (definition: uncontrolled
diabetes is defined as HBIAc >9%).

- Poorly controlled hypertension (uncontrolled hypertension is defined as a systolic
blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm
Hg, even with treatment). Subjects who have hypertension and are controlled on stable
dosages of anti-hypertensive medications can be included.

NCT01163851
Pfizer
Completed
Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin

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