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

Phase 1

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: Niaspan

• Registration Number: NCT01104519
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-15
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Niaspan	Niaspan - Placebo
2	Niaspan	Placebo - Niaspan

Primary Outcome Measures

Name	Time	Method
flow-mediated dilation (FMD) of brachial artery	predose, 4 hours post dose and 24 and hours post dose
Nitroglycerin (GTN) induced dilation of brachial artery	predose, 4 hours post dose and 24 hours post dose