Status:
COMPLETED
Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia
Lead Sponsor:
Kowa Research Institute, Inc.
Conditions:
Primary Dyslipidemia
Mixed Dyslipidemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed dyslipidemia.
Eligibility Criteria
Inclusion
- Male and female subjects with primary hypercholesterolemia or mixed dyslipidemia who are ≥18 and ≤80 years of age at the time of consent
- Plasma Low-density lipoprotein cholesterol (LDL-C) ≥130 milligrams per deciliter (mg/dL) and ≤220 mg/dL and triglyceride (TG) levels of ≤400 mg/dL
Exclusion
- Homozygous familial hypercholesterolemia
- Any conditions which may cause secondary dyslipidemia
- Uncontrolled diabetes mellitus
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT01256476
Start Date
October 1 2010
End Date
June 1 2011
Last Update
May 8 2012
Active Locations (44)
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1
Huntsville, Alabama, United States
2
Muscle Shoals, Alabama, United States
3
Chandler, Arizona, United States
4
Goodyear, Arizona, United States