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

Merck Sharp & Dohme LLC0 sites12 target enrollmentMarch 2008

ConditionsDyslipidemia

InterventionsNiaspan

Overview

Phase: Phase 1
Intervention: Niaspan
Conditions: Dyslipidemia
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 12
Primary Endpoint: flow-mediated dilation (FMD) of brachial artery
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

July 2008

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

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