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

Information source: Kowa Research Institute, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dyslipidemia

Intervention: Pitavastatin (Drug); Pravastatin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Kowa Research Institute, Inc.

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Phoenix, Arizona, United States

Beverly Hills, California, United States

Costa Mesa, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Newport Beach, California, United States

San Francisco, California, United States

Washington, District of Columbia, United States

Coral Gables, Florida, United States

Fort Lauderdale, Florida, United States

Fort Pierce, Florida, United States

Miami Beach, Florida, United States

Miami, Florida, United States

Tampa, Florida, United States

Vero Beach, Florida, United States

Atlanta, Georgia, United States

Decatur, Georgia, United States

Springfield, Massachusetts, United States

Berkley, Michigan, United States

St. Louis, Missouri, United States

Hillsborough, New Jersey, United States

Randolph, New Jersey, United States

New York, New York, United States

Rochester, New York, United States

Huntersville, North Carolina, United States

Addison, Texas, United States

Austin, Texas, United States

Corpus Christi, Texas, United States

Fort Worth, Texas, United States

Harlingen, Texas, United States

Houston, Texas, United States

Longview, Texas, United States

Annandale, Virginia, United States

Seattle, Washington, United States

Spokane, Washington, United States

Additional Information

Starting date: December 2010
Last updated: March 27, 2014

Page last updated: August 23, 2015

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