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Determinants of Warfarin Metabolism

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment target: 600 to 1000v15 Show 4 more changesShow less
    • Primary and study completion dates: Dec 2020 to Dec 2030
    • Primary endpoints: 2 to 8
    • Interventions: Phenytoin (Drug), Warfarin (Drug) to Dicloxacillin (Drug), Flurbiprofen (Drug), Losartan & Hydrochlorothiazide (Drug), Phenytoin (Drug), Siponimod (Drug), Warfarin (Drug)
    • Eligibility criteria expanded, about 8 words
  2. Re-verified, no change to tracked fieldsv14
  3. Enrollment target: 200 to 600
    • Primary and study completion dates: Dec 2020
    • Study arms: 0 to 1
    v13
  4. 5 versions Re-verified since Nov 9, 2006, no change to tracked fieldsv8-v12
  5. Study title shortened, about 2 wordsv7
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  1. 2 versions Re-verified since Mar 5, 2006, no change to tracked fieldsv5-v6
  2. Eligibility criteria expanded, about 3 words
    • Study title expanded, about 2 words
    v4
  3. 2 versions Re-verified since Sep 14, 2005, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The anticoagulant effect of warfarin varies greatly among individuals. Some of this variability is attributed to differences in the activity of CYP2C9, the predominant enzyme involved in the metabolism of S-warfarin. The present study is designed to define the differences in warfarin metabolism among healthy individuals carrying different CYP2C9 genotypes. In addition, the study will define the correlation between the phenytoin metabolic ratio, a marker of CYP2C9 activity in vivo, and warfarin metabolism.
Trial Details
NCT Number NCT00162474
Lead Sponsor Hadassah Medical Organization
Conditions
(from sponsor)		 Healthy
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov