Effects of Niaspan™ on High-density Lipoprotein (HDL) in Healthy Male Subjects (0000-069)

Phase 1

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: Niaspan

• Registration Number: NCT01071291
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will evaluate whether chronic dosing with Niaspan™ increases reverse cholesterol transport, high-density lipoprotein cholesterol (HDL-C) levels, and fecal excretion of cholesterol.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-18
• Study First Posted: 2010-02-19
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-09
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 37

Inclusion Criteria

• Healthy Male Subjects

Exclusion Criteria :

• Subject has a history of stroke, chronic seizures, or major neurological disorder
• Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm A	Niaspan	Arm A will receive a Niaspan treatment in Period 1 and Placebo treatment in Period 2
Arm B	Niaspan	Arm B will receive a Placebo treatment in Period 1 and Niaspan treatment in Period 2

Primary Outcome Measures

Name	Time	Method
Change from baseline in cholesterol efflux	Baseline and 12 weeks
Change from the baseline in High-Density Lipoprotein Cholesterol (HDL-C)	Baseline and 6 weeks