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

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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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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