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

Mixed Dyslipidemia Clinical Trial

— PREVAIL-US  

Official title:

A RANDOMIZED, DOUBLE-BLIND, ACTIVE CONTROLLED, PARALLEL GROUP STUDY OF PITAVASTATIN 4 MG VS. PRAVASTATIN 40 MG IN PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256476
• Other study ID #: NK-104-4.04US
• Status: Completed
• Phase: Phase 4
• First received: December 7, 2010
• Last updated: May 2, 2012
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: May 2012
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Hyperlipidemias
• Mixed Dyslipidemia
• Primary Dyslipidemia

Intervention

Drug:
• pitavastatin
pitavastatin 4 mg once daily (QD)
• pravastatin
Pravastatin 40 mg once daily (QD)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12		Baseline and 12 weeks	No