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

A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate the Effects of Niaspan™ on Reverse Cholesterol Transport in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01071291

Enrollment

Registered

2010-02-19

Start date

2010-02-28

Completion date

2010-09-30

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

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.

Interventions

DRUGNiaspan

Niaspan™

DRUGComparator: Placebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026