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

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

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
Experimental: 1	Drug: ezetimibe (+) simvastatin simvastatin/ezetimibe 10/20 mg Other Names: MK0653A Vytorin®
Active Comparator: 2	Drug: atorvastatin atorvastatin 10 mg Other Name: Lipitor®

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

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Atorvastatin
Ezetimibe
Hypolipidemic Agents

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012