An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia - Tabular View

Tracking Information

First Received Date ^ICMJE

September 23, 2004

Last Updated Date

May 12, 2009

Start Date ^ICMJE

January 2003

Current Primary Outcome Measures ^ICMJE

Plasma LDL-C.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00092664 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Plasma TG and HDL-C; proportion of patients achieving LDL-C targets; tolerability.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

An Extension Study of An Investigational Drug in Patients With Hypercholesterolemia

Official Title ^ICMJE

A Multicenter, Randomized, Double-Blind, Placebo-Controlled "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet in Patients With Primary Hypercholesterolemia

Brief Summary

The purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Hypercholesterolemia

Intervention ^ICMJE

Drug: MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 14 weeks

Study Arms / Comparison Groups

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 ^ICMJE

Completed

Enrollment ^ICMJE

1500

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

High cholesterol

Exclusion Criteria:

Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Expanded Access Status

Administrative Information

NCT ID ^ICMJE

NCT00092664

Responsible Party

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

Study ID Numbers ^ICMJE

2004_043, MK0653A-038

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP