Status:
COMPLETED
Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin
Lead Sponsor:
Pfizer
Conditions:
Hypercholesterolemia
Dyslipidemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of a single dose of PF-04950615 (RN316) in volunteers on stable doses of atorvastatin. PF-04950615 (RN316) ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01163851
Start Date
July 1 2010
End Date
April 1 2011
Last Update
March 1 2018
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Premier Research Group, Limited
Peoria, Arizona, United States, 85381
2
Dedicated Phase 1, Inc.
Phoenix, Arizona, United States, 85013
3
Premier Research Group Limited
Phoenix, Arizona, United States, 85027
4
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66211