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A Study of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01104519
First received: April 13, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  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:

MedlinePlus related topics: Cholesterol
Drug Information available for: Niacin
U.S. FDA Resources

Further study details as provided by Merck:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104519

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01104519     History of Changes
Other Study ID Numbers: 2010_524, 093
Study First Received: April 13, 2010
Last Updated: April 13, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 22, 2013