Overview

Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia

Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kowa Research Institute, Inc.
Treatments:
Pitavastatin
Pravastatin
Criteria
Inclusion Criteria:

- 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 Criteria:

- Homozygous familial hypercholesterolemia

- Any conditions which may cause secondary dyslipidemia

- Uncontrolled diabetes mellitus