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Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)

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: NCT00395603
Recruitment Status : Terminated (This study was terminated early due to poor recruitment.)
First Posted : November 3, 2006
Last Update Posted : February 18, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Study Description
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Brief Summary:
To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Diabetes Mellitus Drug: MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks Drug: Comparator: atorvastatin / Duration of Treatment: 6 Weeks Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compare Ezetimibe 10mg and Simvastatin 40mg vs Atorvastatin 80mg Daily in Subjects With Cardiovascular Heart Disease and/or Diabetes Mellitus With Uncontrolled Lipids on Statin Therapy
Study Start Date : September 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Percentage reduction in ldl-c at end-point after 6 weeks.

Eligibility Criteria
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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:

  • Greater than 18 years of age
  • Treated for at least the last 3 months with a daily dose of atorvastatin 40 mg
  • Existing coronary heart disease and cholesterol > 4.0 mmol/l

Exclusion Criteria:

  • Uncontrolled diabetes
  • Elevated liver function tests
  • Elevated creatine kinase (ck)
  • Triglycerides (tg) > 4.5 mmol/l
  • Drug or alcohol dependency within 6 months prior to visit 1
  • Woman receiving hormonal therapy who have not been maintained on a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen for the duration of the study
  • Woman of childbearing potential not using an acceptable method of birth control
  • Women who are pregnant or breast feeding
Contacts and Locations
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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): NCT00395603


Sponsors and Collaborators
Organon and Co
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
More Information
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Additional Information:

Study Data/Documents: CSR Synopsis Link  This link exits the ClinicalTrials.gov site

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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00395603    
Other Study ID Numbers: 0653A-122
2006_042
First Posted: November 3, 2006    Key Record Dates
Last Update Posted: February 18, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atorvastatin
Simvastatin
Ezetimibe
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors