NCT01071291

CompletedPhase 1

Effects of Niaspan™ on High-density Lipoprotein (HDL) in Hea...

Merck Sharp & Dohme LLC Source

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Other study identifiers

Sponsor study identifier

0000-069

Secondary identifiers

069

2010_510

Study Type

interventional

Actual enrollment (reported)

37

Locations

0 countries

Sites

N/A

Timeline

Study Start

February 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2010

Actual (reported)

Study Completion

September 2010

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 37 participants
Study completion date: September 2010
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
February 17, 2010
Actual (reported)
First Posted
February 19, 2010
Actual (reported)
Primary Completion
August 2010
Actual (reported)
Study Completion
September 2010
Actual (reported)

Last Updated: October 12, 2015
Status Verified: October 2015
Last Update Submitted: 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 A

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:

Sponsors & Collaborators

Merck Sharp & Dohme LLC
Industrylead

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

Enrollment

37 participants (actual enrollment reported by the registry).

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 2010

Date type not reported

This date has not been verified as actual or estimated.

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Arm B

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.

Primary Completion

August 2010

Actual (reported)

Study Completion

September 2010

Actual (reported)

Last Updated

October 12, 2015

Record last verified: 2015-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01071291
Data provider: ClinicalTrials.gov
Source updated: 2015-10-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:51 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Arm A

Arm B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record