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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Dyslipidemia

Treatments: Drug: Comparator: Placebo; Drug: Niaspan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01071291

2010_510

069

0000-069

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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37 participants in 2 patient groups

Arm A

Experimental group

Description:

Arm A will receive a Niaspan treatment in Period 1 and Placebo treatment in Period 2

Treatment:

Drug: Comparator: Placebo

Drug: Niaspan

Arm B

Experimental group

Description:

Arm B will receive a Placebo treatment in Period 1 and Niaspan treatment in Period 2

Treatment:

Drug: Comparator: Placebo

Drug: Niaspan