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

Phase 3TerminatedNCT00395603

Organon and Co550 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

550

Conditions

Cardiovascular Diseases Diabetes Mellitus

Interventions

MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 WeeksDRUG

Comparator: atorvastatin / Duration of Treatment: 6 WeeksDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.