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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01104519
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: Niaspan Drug: Comparator: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : March 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Niacin

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. flow-mediated dilation (FMD) of brachial artery [ Time Frame: predose, 4 hours post dose and 24 and hours post dose ]
  2. Nitroglycerin (GTN) induced dilation of brachial artery [ Time Frame: predose, 4 hours post dose and 24 hours post dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104519


Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT01104519    
Other Study ID Numbers: 0000-093
093
2010_524
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Niacin
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs