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

Phase 4

Completed

• Conditions: Primary Dyslipidemia; Mixed Dyslipidemia
• Interventions: Drug: pitavastatin; Drug: pravastatin

• Registration Number: NCT01256476
• Lead Sponsor: Kowa Research Institute, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2010-12-07
• Study First Posted: 2010-12-08
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2012-04-03
• Results First Submitted QC: 2012-04-03
• Results First Posted: 2012-04-30
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-02
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pitavastatin 4 mg once daily (QD)	pitavastatin	-
pravastatin 40 mg once daily (QD)	pravastatin	-

Primary Outcome Measures

Name	Time	Method
Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12	Baseline and 12 weeks