Endpoint Validation Study (0524A-015)

February 16, 2017 updated by: Merck Sharp & Dohme LLC

A Randomized, Double-Blind, Placebo-Controlled Endpoint Selection and Questionnaire Validation Study to Assess the Niacin Induced Flushing Caused by NIASPAN (TM)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

165

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 19, 2007

First Submitted That Met QC Criteria

September 19, 2007

First Posted (Estimate)

September 21, 2007

Study Record Updates

Last Update Posted (Actual)

February 17, 2017

Last Update Submitted That Met QC Criteria

February 16, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0524A-015
  • MK0524A-015
  • 2007_612

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Snyopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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