Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

March 9, 2009

Start Date ^ICMJE

October 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

LDL-C Lowering Efficacy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

LDL-C lowering efficacy

Change History

Complete list of historical versions of study NCT00166504 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

safety

Descriptive Information

Brief Title ^ICMJE

Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study

Official Title ^ICMJE

A Multicenter, Randomized, Open-Label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia

Brief Summary

This is an efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Condition ^ICMJE

Hypercholesterolemia

Intervention ^ICMJE

Drug: ezetimibe (+) simvastatin
simvastatin/ezetimibe 10/20 mg
Other Names:
- MK0653A
- Vytorin®
Drug: atorvastatin
atorvastatin 10 mg

Other Name: Lipitor®

Study Arms / Comparison Groups

1: Experimental
Intervention: Drug: ezetimibe (+) simvastatin
2: Active Comparator
Intervention: Drug: atorvastatin

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

203

Completion Date

October 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Clinical diagnosis of hypercholesterolemia
LDL-C >/= 130 mg/dL but </=250 mg/dL and TG </= 350 mg/dL
NCEP ATP III guideline

Exclusion Criteria:

Hypersensitivity to HMG-CoA inhibitor or Ezetimibe

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00166504

Responsible Party

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

Study ID Numbers ^ICMJE

2005_070, MK0653A-092

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

March 2009

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