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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01104519
First received: April 13, 2010
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Dyslipidemia
Drug: Niaspan
Drug: Comparator: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • flow-mediated dilation (FMD) of brachial artery [ Time Frame: predose, 4 hours post dose and 24 and hours post dose ] [ Designated as safety issue: No ]
  • Nitroglycerin (GTN) induced dilation of brachial artery [ Time Frame: predose, 4 hours post dose and 24 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: March 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Niaspan - Placebo
Drug: Niaspan
Oral doses of 2000 mg of Niaspan once daily for 7 days.
Drug: Comparator: Placebo
Oral doses of placebo once daily for 7 days.
Experimental: 2
Placebo - Niaspan
Drug: Niaspan
Oral doses of 2000 mg of Niaspan once daily for 7 days.
Drug: Comparator: Placebo
Oral doses of placebo once daily for 7 days.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01104519

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01104519     History of Changes
Other Study ID Numbers: 0000-093, 093, 2010_524
Study First Received: April 13, 2010
Last Updated: May 2, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014