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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: March 27, 2014
Last verified: March 2014
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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

Primary Outcome Measures:
  • Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks [ Time Frame: 12 weeks minus baseline ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Results First Received: February 10, 2014
Last Updated: March 27, 2014

Additional relevant MeSH terms:
Dyslipidemias
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

ClinicalTrials.gov processed this record on September 21, 2017