Effect of MK0524A on Cholesterol Levels (0524A-048)

September 1, 2015 updated by: Merck Sharp & Dohme LLC

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Lipid-Altering Efficacy and Safety and Tolerability of MK0524A in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia

The primary objective of the study is to assess the effects of MK0524A in reducing cholesterol levels in an Asian population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

646

Phase

  • Phase 3

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:

  • 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 not being able to take niacin or niacin-containing products
  • 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

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
placebo
Drug: Comparator: placebo

Treatment Period 1: one 20mg/1g tablet placebo to laropiprant/niacin once daily for 4 weeks

Treatment Period 2: two 20mg/1g tablets of placebo to laropiprant/niacin once daily for 8 weeks.

All patients will receive placebo for a 4 week run-in period before randomization.
EXPERIMENTAL: 1
laropiprant/niacin (MK0524A)
Drug: laropiprant/niacin (MK0524A)

Treatment Period 1: one 20mg/1g tablet laropiprant/niacin once daily for 4 weeks

Treatment Period 2: two 20mg/1g tablets laropiprant/niacin once daily for 8 weeks.

All patients will receive placebo for a 4 week run-in period before randomization

Other Names:
  • MK0524A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks
Time Frame: 12 weeks
Low Density Lipoprotein Cholesterol (LDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks
Time Frame: 12 weeks
Percent change from baseline in High Density Lipoprotein Cholesterol (HDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure *100
12 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, 2007

Primary Completion (ACTUAL)

March 1, 2008

Study Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

September 26, 2007

First Submitted That Met QC Criteria

September 26, 2007

First Posted (ESTIMATE)

September 27, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0524A-048
  • 2007_621

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.

Clinical Trials on Hypercholesterolemia

Clinical Trials on laropiprant/niacin (MK0524A)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe