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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01256476
First Posted: December 8, 2010
Last Update Posted: May 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kowa Research Institute, Inc.
  Purpose
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.

Condition Intervention Phase
Primary Dyslipidemia Mixed Dyslipidemia Drug: pitavastatin Drug: pravastatin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Kowa Research Institute, Inc.:

Primary Outcome Measures:
  • Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12 [ Time Frame: Baseline and 12 weeks ]

Enrollment: 328
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pitavastatin 4 mg once daily (QD) Drug: pitavastatin
pitavastatin 4 mg once daily (QD)
Other Name: Livalo
Active Comparator: pravastatin 40 mg once daily (QD) Drug: pravastatin
Pravastatin 40 mg once daily (QD)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256476


  Show 44 Study Locations
Sponsors and Collaborators
Kowa Research Institute, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01256476     History of Changes
Other Study ID Numbers: NK-104-4.04US
First Submitted: December 7, 2010
First Posted: December 8, 2010
Results First Submitted: April 3, 2012
Results First Posted: April 30, 2012
Last Update Posted: May 8, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders
Metabolic Diseases
Pravastatin
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors