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

• Status: Terminated
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Atorvastatin; Atorvastatin Calcium; Ezetimibe; Simvastatin

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