NCT01071291

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

6 months

First QC Date

February 17, 2010

Last Update Submit

October 9, 2015

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Arm A

EXPERIMENTAL

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

Drug: NiaspanDrug: Comparator: Placebo

Arm B

EXPERIMENTAL

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

Drug: NiaspanDrug: Comparator: Placebo

Interventions

NiaspanDRUG

Niaspan™

Also known as: NIASPAN™
Arm AArm B
Comparator: PlaceboDRUG

Placebo

Arm AArm B

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Male Subjects

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dyslipidemias

Interventions

Niacin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2010

First Posted

February 19, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

October 12, 2015

Record last verified: 2015-10