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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dyslipidemia

Intervention: Niaspan (Drug); Comparator: Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

flow-mediated dilation (FMD) of brachial artery

Nitroglycerin (GTN) induced dilation of brachial artery

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: March 2008
Last updated: July 29, 2015

Page last updated: August 23, 2015

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