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

Merck Sharp & Dohme LLC37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dyslipidemia

Interventions

NiaspanDRUG

Niaspan™

Comparator: PlaceboDRUG

Placebo

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline in cholesterol efflux

Time frame: Baseline and 12 weeks

Change from the baseline in High-Density Lipoprotein Cholesterol (HDL-C)

Time frame: Baseline and 6 weeks

Data from ClinicalTrials.gov

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