Vytorin Treating Uncontrolled Lipids (VyTUL) Study

This study has been terminated.
(This study was terminated early due to poor recruitment.)
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00395603
First received: November 2, 2006
Last updated: October 18, 2007
Last verified: October 2007
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage reduction in ldl-c at end-point after 6 weeks.

Estimated Enrollment: 550
Study Start Date: April 2007
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395603

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

No publications provided

ClinicalTrials.gov Identifier: NCT00395603     History of Changes
Other Study ID Numbers: 2006_042
Study First Received: November 2, 2006
Last Updated: October 18, 2007
Health Authority: Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
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
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014