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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01104519

Enrollment

Registered

2010-04-15

Start date

2008-03-31

Completion date

2008-07-31

Last updated

2015-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

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.

Interventions

DRUGNiaspan

Oral doses of 2000 mg of Niaspan once daily for 7 days.

DRUGComparator: Placebo

Oral doses of placebo once daily for 7 days.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
flow-mediated dilation (FMD) of brachial artery	predose, 4 hours post dose and 24 and hours post dose
Nitroglycerin (GTN) induced dilation of brachial artery	predose, 4 hours post dose and 24 hours post dose

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026