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NCT00395603 Clinical Trial

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

Cardiovascular Diseases Clinical Trial

Official title:
Compare Ezetimibe 10mg and Simvastatin 40mg vs Atorvastatin 80mg Daily in Subjects With Cardiovascular Heart Disease and/or Diabetes Mellitus With Uncontrolled Lipids on Statin Therapy

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00395603
Other study ID # 0653A-122
Secondary ID 2006_042
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 2006
Est. completion date June 2007

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 550
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

• Comparator: atorvastatin / Duration of Treatment: 6 Weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage reduction in ldl-c at end-point after 6 weeks.
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