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

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01301066
• Other study ID #: NK-104-4.05US
• Status: Completed
• Phase: Phase 4
• First received: February 18, 2011
• Last updated: March 27, 2014
• Start date: December 2010
• Est. completion date: March 2013

Study information

• Verified date: March 2014
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• Pitavastatin
Pitavastatin 4 mg QD
• Pravastatin
Pravastatin 40 mg QD

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.	Eli Lilly and Company, Kowa Pharmaceuticals America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks		12 weeks minus baseline	No