Endpoint Validation Study (0524A-015)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-12-31

Brief Summary

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To determine the most effective daily dose of MK0524A when compared with placebo after the 8-week treatment period for Niacin Induce Flushing (NIF).

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Detailed Description

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Conditions

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Flushing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0524A, /Duration of Treatment : 8 Weeks

Intervention Type DRUG

Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must be male or female between 18 to 70 years
* Qualified women must be sterile (through surgery) and/or post-menopausal, and/or agree to use birth control

Exclusion Criteria

* You are a woman who is having hot flashes, receiving Hormone Replacement Therapy (HRT), and/or other therapies for hot flashes
* You are currently using Niacin/or Niacin containing products with a daily dose over 50 mg/day
* You are sensitive to niacin
* You have a history gout
* You drink more than 2 glasses of alcohol per day and you are not willing to stop
* You don't have access to a telephone

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No