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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm A

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

Group Type EXPERIMENTAL

Niaspan

Intervention Type DRUG

Niaspan™

Comparator: Placebo

Intervention Type DRUG

Placebo

Arm B

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

Group Type EXPERIMENTAL

Niaspan

Intervention Type DRUG

Niaspan™

Comparator: Placebo

Intervention Type DRUG

Placebo

Interventions

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Niaspan

Niaspan™

Intervention Type DRUG

Comparator: Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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NIASPAN™

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes