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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Dyslipidemia

Treatments: Drug: Niaspan; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01104519

2010_524

0000-093

093

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

12 participants in 2 patient groups

1

Experimental group

Description:

Niaspan - Placebo

Treatment:

Drug: Niaspan

Drug: Comparator: Placebo

2

Experimental group

Description:

Placebo - Niaspan

Treatment:

Drug: Niaspan

Drug: Comparator: Placebo