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A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects

This study has been completed.
Sponsor:
Collaborators:
Kowa Pharmaceuticals America, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01301066
First received: February 18, 2011
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.


Condition Intervention Phase
Dyslipidemia
 Drug: Pitavastatin
Drug: Pravastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects With Dyslipidemia, Followed by a 40-Week Safety Extension Study

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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

Primary Outcome Measures:
  • Percent change of fasting serum low-density lipoprotein cholesterol (LDL-C) at 12 weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    To compare the between-group difference in percent change of fasting serum low-density lipoprotein cholesterol (LDL-C) at 12 weeks in HIV-infected subjects


Enrollment: 252
Study Start Date: December 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pitavastatin 4 mg QD Drug: Pitavastatin
Pitavastatin 4 mg QD
Other Name: Livalo
Active Comparator: Pravastatin 40 mg QD Drug: Pravastatin
Pravastatin 40 mg QD

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females (non-pregnant, non-lactating females) 18-70 years of age, inclusive, at time of consent.
  • Both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age >40 years without menses for ≥2 years) must agree to use at least 2 reliable forms of contraception
  • Documented HIV infection.

Exclusion Criteria:

  • Homozygous familial hypercholesterolemia
  • Any conditions that may cause secondary dyslipidemia
  • History of coronary artery disease (CAD) or CAD equivalent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301066

  Show 35 Study Locations
Sponsors and Collaborators
Kowa Research Institute, Inc.
Kowa Pharmaceuticals America, Inc.
Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01301066     History of Changes
Other Study ID Numbers: NK-104-4.05US
Study First Received: February 18, 2011
Last Updated: April 12, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013