Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)
Primary Purpose
Cardiovascular Diseases, Diabetes Mellitus
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks
Comparator: atorvastatin / Duration of Treatment: 6 Weeks
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Diseases
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Percentage reduction in ldl-c at end-point after 6 weeks.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00395603
Brief Title
Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated early due to poor recruitment.
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
550 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: atorvastatin / Duration of Treatment: 6 Weeks
Primary Outcome Measure Information:
Title
Percentage reduction in ldl-c at end-point after 6 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Description
Click here to access a synopsis of the study results.
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis Link
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)
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