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

Last updated: August 12, 2024
Sponsor: Organon and Co
Overall Status: Terminated

Phase

3

Condition

Vascular Diseases

Diabetes Prevention

Diabetes And Hypertension

Treatment

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

Comparator: atorvastatin / Duration of Treatment: 6 Weeks

Clinical Study ID

NCT00395603
0653A-122
2006_042
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 andregimen for at least 8 weeks and are willing to continue the same regimen for theduration of the study

  • Woman of childbearing potential not using an acceptable method of birth control

  • Women who are pregnant or breast feeding

Study Design

Total Participants: 550
Treatment Group(s): 2
Primary Treatment: MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks
Phase: 3
Study Start date:
September 01, 2006
Estimated Completion Date:
June 30, 2007