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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00166504
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : November 5, 2008
Last Update Posted : February 22, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Brief Summary:
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 or disease Intervention/treatment Phase
Hypercholesterolemia Drug: ezetimibe (+) simvastatin Drug: atorvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007


Arm Intervention/treatment
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®




Primary Outcome Measures :
  1. LDL-C Lowering Efficacy [ Time Frame: 6 weeks ]
    LDL-C = low density lipoprotein cholesterol, measured in mg/dl.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00166504


Sponsors and Collaborators
Organon and Co
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00166504    
Other Study ID Numbers: 0653A-092
MK0653A-092
2005_070
First Posted: September 14, 2005    Key Record Dates
Results First Posted: November 5, 2008
Last Update Posted: February 22, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Simvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors