Effect of MK0524A on Flushing Caused by Niacin (0524A-056)

The primary objective of the study is to assess the effects of MK0524A in reducing flushing associated with niacin.

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Key information

Conditions

Flushing Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient is male or female between 18 and 70 years of age
Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study

Exclusion criteria

Patient has a history of hypersensitivity to niacin or niacin-containing products
Patient is currently experiencing menopausal hot flashes
Patient consumes more than 2 alcoholic beverages per day
Patient has poorly controlled Type 1 or Type 2 diabetes mellitus
Patient engages in vigorous exercise or an aggressive diet regimen

Treatment and study plan

MK0524A, /Duration of Treatment : 4 Weeks

Drug

Comparator : niacin /Duration of Treatment : 1 Weeks

Drug

Primary outcomes

MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by maximum Global Flushing Severity Score (GFSS) categorized as none/mild, moderate, severe, extreme.

Time frame: Over 1 week

Secondary outcomes

MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by (a) maximum daily GFSS; and (b) percentage of patients with a maximum GFSS =4 (moderate or greater).

Time frame: Daily

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Tolerability and Effect of MK0524A on Niacin-Induced Acute Flushing in Lipid Clinic Patients

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Sep 21, 2007
Registry last updated: Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed