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

Phase 3

Terminated

• Conditions: Cardiovascular Diseases; Diabetes Mellitus

• Registration Number: NCT00395603
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-11-02
• Study First Submitted QC: 2006-11-02
• Study First Posted: 2006-11-03
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage reduction in ldl-c at end-point after 6 weeks.