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Determinants of Warfarin Metabolism

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 600 to 1000 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) · 1 morev15 Show all 5 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

    See this version in full on ClinicalTrials.gov ↗

  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 1v13 Show all 3 changesShow less
    • Primary and study completion dates: Dec 2020
    • Study arms: 0 to 1
  4. 5 versions Re-verified since Nov 9, 2006, no change to tracked fieldsv8-v12
  5. Study title shortened, about 2 wordsv7 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

Show 5 earlier versionsHide 5 earlier versions
  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 wordsv4 Show all 2 changesShow less
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Healthy
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov