MK0524A Clinical Efficacy Study (0524A-026)(COMPLETED)

Phase 2

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT00533312
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A study to determine lipid changing effects of MK0524A when compared to niacin extended release (NIASPAN) and placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2005-07
• Study Completion: 2007-01
• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2007-09-19
• Study First Posted: 2007-09-21
• Status Verified: 2017-03
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 407

Inclusion Criteria

• Patients must be between the ages of 18 and 70 years
• Female patients must be pre-menopausal women that have been surgically sterilized, not pregnant and/or not planning to become pregnant

Exclusion Criteria

• Patient has a history of peptic ulcer or gout
• Patient is sensitive to niacin or products containing niacin
• Patient drinks more than 2 alcoholic drinks per day
• Patient has certain heart disease, cancer, or is HIV positive

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.	After 4 weeks

Secondary Outcome Measures

Name	Time	Method
To asses the triglyceride-lowering effects of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.	After 4 weeks