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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

February 18, 2011
March 27, 2014
December 2010
March 2013   (final data collection date for primary outcome measure)
Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks [ Time Frame: 12 weeks minus baseline ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01301066 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dyslipidemia
  • Drug: Pitavastatin
    Pitavastatin 4 mg QD
    Other Name: Livalo
  • Drug: Pravastatin
    Pravastatin 40 mg QD
  • Experimental: Pitavastatin 4 mg QD
    Intervention: Drug: Pitavastatin
  • Active Comparator: Pravastatin 40 mg QD
    Intervention: Drug: Pravastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
252
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01301066
NK-104-4.05US
No
Kowa Research Institute, Inc.
Kowa Research Institute, Inc.
  • Kowa Pharmaceuticals America, Inc.
  • Eli Lilly and Company
Not Provided
Kowa Research Institute, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP