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Completed

NCT Number: NCT01301066

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.

Completed

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pitavastatin

Drug

Pitavastatin 4 mg QD

Other names: Livalo

Pravastatin

Drug

Pravastatin 40 mg QD

Primary outcomes

  1. Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks

    Time frame: 12 weeks minus baseline

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Collaborators

  • Eli Lilly and Company
  • Kowa Pharmaceuticals America, Inc.

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 23, 2011
Registry last updated
Apr 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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