Ezetimibe (+) Simvastatin vs. Atorvastatin Comparative Study in DM or Metabolic Syndrome Patients

This study has been completed.

First Received: September 7, 2005 Last Updated: March 7, 2008 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00157924

Purpose

An efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin at week 6 in diabetics or metabolic syndrome patients in Korea.

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

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Atorvastatin Atorvastatin calcium Ezetimibe

U.S. FDA Resources

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

Further study details as provided by Merck:

Primary Outcome Measures:

LDL-C lowering efficacy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	190
Study Start Date:	November 2005
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

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

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
Drug naive or statin treated but inadequately controlled patients against NCEP ATP III guideline goal

Exclusion Criteria:

Hypersensitivity to HMG-CoA inhibitor or Ezetimibe

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157924

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_064, MK0653A-093
Study First Received:	September 7, 2005
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00157924 History of Changes
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Simvastatin
Antilipemic Agents
Diabetes Mellitus
Ezetimibe

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypercholesterolemia
Metabolic Disorder
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

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 May 06, 2009