Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study

This study has been completed.

First Received: September 9, 2005 Last Updated: March 9, 2009 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00166504

Purpose

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

Condition	Intervention	Phase
Hypercholesterolemia	Drug: ezetimibe (+) simvastatin Drug: atorvastatin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Open-Label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Atorvastatin Atorvastatin calcium Ezetimibe

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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

Enrollment:	203
Study Start Date:	October 2005
Study Completion Date:	October 2007

Arms	Assigned Interventions
1: Experimental	Drug: ezetimibe (+) simvastatin simvastatin/ezetimibe 10/20 mg
2: Active Comparator	Drug: atorvastatin atorvastatin 10 mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166504

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_070, MK0653A-092
Study First Received:	September 9, 2005
Results First Received:	October 13, 2008
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00166504 History of Changes
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Ezetimibe

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 20, 2009