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Determinants of Warfarin Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00162474
Recruitment Status : Recruiting
First Posted : September 13, 2005
Last Update Posted : March 6, 2017
Information provided by (Responsible Party):
Yosef Caraco, Hadassah Medical Organization

Brief Summary:

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.

Condition or disease Intervention/treatment
Healthy Drug: Warfarin Drug: Phenytoin

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Correlation Between Phenotypic Activity of CYP2C9 and Genetic Polymorphism in CYP2C9 and Warfarin Metabolism.
Study Start Date : September 2003
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Warfarin Drug: Warfarin Drug: Phenytoin

Primary Outcome Measures :
  1. Warfarin oral clearance [ Time Frame: 2 weeks ]
  2. Formation clearance of CYP2C9 mediated warfarin metabolites [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age range of 20-50 years old
  • The absence of significant disease states

Exclusion Criteria:

  • Known hypersensitivity to warfarin or phenytoin
  • The presence of significant disease states
  • Regular use of drugs (including birth control pills)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00162474

Contact: Yoseph Caraco, MD 00 972 2 6778584

Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
Principal Investigator: Yoseph Caraco, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Yoseph Caraco, MD Hadassah Medical Organization

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yosef Caraco, Head, Clinical Pharmacology Unit, Division of Medicine, Hadassah Medical Organization Identifier: NCT00162474     History of Changes
Other Study ID Numbers: yc195510-HMO-CTIL
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017

Keywords provided by Yosef Caraco, Hadassah Medical Organization:
Healthy Volunteers

Additional relevant MeSH terms:
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers