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

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ClinicalTrials.gov Identifier: NCT01104519
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Niacin
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
Contacts and Locations

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01104519     History of Changes
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:
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
Growth Substances
Physiological Effects of Drugs