Back to resultsA Study of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity (0000-093)
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Niaspan
Comparator: Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Niaspan - Placebo
Placebo - Niaspan
Outcomes
Primary Outcome Measures
flow-mediated dilation (FMD) of brachial artery
Nitroglycerin (GTN) induced dilation of brachial artery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01104519
Brief Title
A Study of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity (0000-093)
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 Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Niaspan - Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Placebo - Niaspan
Intervention Type
Drug
Intervention Name(s)
Niaspan
Intervention Description
Oral doses of 2000 mg of Niaspan once daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
Oral doses of placebo once daily for 7 days.
Primary Outcome Measure Information:
Title
flow-mediated dilation (FMD) of brachial artery
Time Frame
predose, 4 hours post dose and 24 and hours post dose
Title
Nitroglycerin (GTN) induced dilation of brachial artery
Time Frame
predose, 4 hours post dose and 24 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity (0000-093)
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