Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)
NCT ID: NCT00395603
Last Updated: 2024-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
550 participants
INTERVENTIONAL
2006-09-30
2007-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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MK0653A, ezetimibe (+) simvastatin / Duration of Treatment: 6 Weeks
Comparator: atorvastatin / Duration of Treatment: 6 Weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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2006_042
Identifier Type: -
Identifier Source: secondary_id
0653A-122
Identifier Type: -
Identifier Source: org_study_id
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