Status:
TERMINATED
Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)
Lead Sponsor:
Organon and Co
Conditions:
Cardiovascular Diseases
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT00395603
Start Date
September 1 2006
End Date
June 1 2007
Last Update
August 15 2024
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