A Study of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity (0000-093)

NCT ID: NCT01104519

Last Updated: 2015-07-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A study to evaluate the inter- and intra subject variabilities of flow-mediated dilation (FMD) of brachial artery and nitroglycerin (GTN) induced dilation of brachial artery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyslipidemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Niaspan - Placebo

Group Type EXPERIMENTAL

Niaspan

Intervention Type DRUG

Oral doses of 2000 mg of Niaspan once daily for 7 days.

Comparator: Placebo

Intervention Type DRUG

Oral doses of placebo once daily for 7 days.

2

Placebo - Niaspan

Group Type EXPERIMENTAL

Niaspan

Intervention Type DRUG

Oral doses of 2000 mg of Niaspan once daily for 7 days.

Comparator: Placebo

Intervention Type DRUG

Oral doses of placebo once daily for 7 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Niaspan

Oral doses of 2000 mg of Niaspan once daily for 7 days.

Intervention Type DRUG

Comparator: Placebo

Oral doses of placebo once daily for 7 days.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate methods of contraception throughout the study
* Subject is in good health (other than history of high cholesterol)
* Subject is a non-smoker

Exclusion Criteria

* Subject has a history of stroke, seizures or major neurological disorder
* Subject has a history of cancer
* Subject is unable to refrain from or anticipates the use any prescription or non-prescription drugs
* Subjects consumes excessive amounts of alcohol or caffeine
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

093

Identifier Type: -

Identifier Source: secondary_id

2010_524

Identifier Type: -

Identifier Source: secondary_id

0000-093

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effects of Niacin On Fatty Acid Trapping
NCT01984073 COMPLETED PHASE1
Benefit of Elevation of HDL-C in Women
NCT01921010 COMPLETED PHASE4