Endpoint Validation Study - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00533676

Purpose

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

Condition	Intervention	Phase
Flushing	Drug: MK0524A, /Duration of Treatment : 8 Weeks Drug: Comparator : placebo (unspecified) /Duration of Treatment : 8 Weeks	Phase II

Drug Information available for: Laropiprant Niacin Niacin hydrochloride

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Endpoint Selection and Questionnaire Validation Study to Assess the Niacin Induced Flushing Caused by NIASPAN (TM)

Further study details as provided by Merck:

Primary Outcome Measures:

To determine the most effective daily dose and measurements to assess acute and chronic (long-lasting) Niacin Induce Flushing (NIF). [ Time Frame: 8 weeks ]

Secondary Outcome Measures:

To assess the the time points of Niacin Induce Flushing (NIF) across the 8-week treatment period. [ Time Frame: 8 weeks ]

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533676

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications indexed to this study:

Study ID Numbers:	2007_612
Study First Received:	September 19, 2007
Last Updated:	September 26, 2007
ClinicalTrials.gov Identifier:	NCT00533676
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Nicotinic Acids
Signs and Symptoms
Flushing
Niacin

ClinicalTrials.gov processed this record on January 16, 2009