Ezetimibe (+) Simvastatin vs. Atorvastatin Comparative Study in DM or Metabolic Syndrome Patients (0653A-093)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: September 7, 2005
Last updated: May 13, 2016
Last verified: May 2016
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
Drug: simvastatin (+) ezetimibe
Drug: atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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 Hypercholesterolemic Patients With Diabetes Mellitus or Metabolic Syndrome

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • LDL-C lowering efficacy [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 6 weeks ]

Enrollment: 190
Study Start Date: November 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
1. simvastatin/ezetimibe 10/20mg
Drug: simvastatin (+) ezetimibe
simvastatin (+) ezetimibe 10/20mg.
Other Names:
  • MK0653A
  • Vytorin®
Active Comparator: 2
2. atorvastatin 10mg
Drug: atorvastatin
atorvastatin 10mg
Other Name: Lipitor®


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00157924     History of Changes
Other Study ID Numbers: 0653A-093  MK0653A-093  2005_064 
Study First Received: September 7, 2005
Last Updated: May 13, 2016

Additional relevant MeSH terms:
Metabolic Syndrome X
Lipid Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Glucose Metabolism Disorders
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on January 24, 2017