Effect of MK0524A on Cholesterol Levels - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 26, 2007

Last Updated Date

November 18, 2008

Start Date ^†

April 2007

Current Primary Outcome Measures ^†

MK0524A reduces LDL cholesterol over a 12 week treatment period when compared to placebo. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00536510 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

MK0524A raises HDL cholesterol over a 12 week treatment period when compared to placebo. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Effect of MK0524A on Cholesterol Levels

Official Title ^†

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Hypercholesterolemia
Hyperlipidemia

Intervention ^†

Drug: laropiprant/niacin (MK0524A)
Drug: Comparator: placebo

Study Arms / Comparison Groups

Experimental: laropiprant/niacin (MK0524A)
Placebo Comparator: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

646

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00536510

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Secondary IDs ^††

MK0524A-048

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

November 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.