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

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01104519
• Other study ID #: 0000-093
• Secondary ID: 0932010_524
• Status: Completed
• Phase: Phase 1
• First received: April 13, 2010
• Last updated: July 29, 2015
• Start date: March 2008
• Est. completion date: July 2008

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• Niaspan
Oral doses of 2000 mg of Niaspan once daily for 7 days.
• Comparator: Placebo
Oral doses of placebo once daily for 7 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	flow-mediated dilation (FMD) of brachial artery		predose, 4 hours post dose and 24 and hours post dose	No
Primary	Nitroglycerin (GTN) induced dilation of brachial artery		predose, 4 hours post dose and 24 hours post dose	No