MK0524A Clinical Efficacy Study (0524A-026)(COMPLETED)

April 5, 2017 updated by: Merck Sharp & Dohme LLC

A Multicenter, Randomized, Double-Blinded, Parallel-Design Study to Evaluate the Lipid-Altering Efficacy of 2 Formulations of MK0524A Compared to NIASPAN (TM)

A study to determine lipid changing effects of MK0524A when compared to niacin extended release (NIASPAN) and placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

407

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 between the ages of 18 and 70 years
  • Female patients must be pre-menopausal women that have been surgically sterilized, not pregnant and/or not planning to become pregnant

Exclusion Criteria:

  • Patient has a history of peptic ulcer or gout
  • Patient is sensitive to niacin or products containing niacin
  • Patient drinks more than 2 alcoholic drinks per day
  • Patient has certain heart disease, cancer, or is HIV positive

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 assess the HDL-C raising efficacy of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.
Time Frame: After 4 weeks
After 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To asses the triglyceride-lowering effects of MK-0524A when compared with niacin extended release (NIASPAN) and placebo.
Time Frame: After 4 weeks
After 4 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

April 1, 2005

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

January 1, 2007

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)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0524A-026
  • 2007_619

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

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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