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

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.

Completed

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Niaspan

Drug

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

Comparator: placebo

Drug

Oral doses of placebo once daily for 7 days.

Primary outcomes

flow-mediated dilation (FMD) of brachial artery

Time frame: predose, 4 hours post dose and 24 and hours post dose
Nitroglycerin (GTN) induced dilation of brachial artery

Time frame: predose, 4 hours post dose and 24 hours post dose

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate the Effects of Multiple Oral Doses of 2000 mg of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity in Subjects With Hypercholesterolemia

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Apr 15, 2010
Registry last updated: Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed