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

Phase 3CompletedNCT00533611

Merck Sharp & Dohme LLC330 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

330

Conditions

Flushing

Interventions

MK0524A, /Duration of Treatment : 4 WeeksDRUG

Comparator : niacin /Duration of Treatment : 1 WeeksDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

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

Data from ClinicalTrials.gov

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