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

Organon

Status and phase

Terminated

Phase 3

Conditions

Diabetes Mellitus

Cardiovascular Diseases

Treatments

Drug: Comparator: atorvastatin / Duration of Treatment: 6 Weeks

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00395603

0653A-122

2006_042

Details and patient eligibility

About

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.

Enrollment

550 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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