Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00166504
First received: September 9, 2005
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.


Condition Intervention Phase
Hypercholesterolemia
Drug: ezetimibe (+) simvastatin
Drug: atorvastatin
Phase 4

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:


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

Primary Outcome Measures:
  • LDL-C Lowering Efficacy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    LDL-C = low density lipoprotein cholesterol, measured in mg/dl.


Enrollment: 203
Study Start Date: October 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vytorin
Ezetimibe 10 mg/Simvastatin 20 mg
Drug: ezetimibe (+) simvastatin
simvastatin/ezetimibe 10/20 mg
Other Names:
  • MK0653A
  • Vytorin®
Active Comparator: Atorvastatin
Atorvastatin 10 mg
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 triglyceride (TG) </= 350 mg/dL
  • National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline

Exclusion Criteria:

  • Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors or Ezetimibe
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166504

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00166504     History of Changes
Other Study ID Numbers: 0653A-092, MK0653A-092, 2005_070
Study First Received: September 9, 2005
Results First Received: October 13, 2008
Last Updated: January 3, 2014
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 April 17, 2014