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Trial record 50 of 226 for:    warfarin AND International

Genetic Variability in the Response to Warfarin at Baseline and During Induction of CYP2C9

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. Read our disclaimer for details. Identifier: NCT01388075
Recruitment Status : Unknown
Verified July 2011 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : July 6, 2011
Last Update Posted : July 6, 2011
Information provided by:
Hadassah Medical Organization

Brief Summary:
The genetic factors associated with variability in CYP2C9 induction have not been elucidated. The hypothesis underlying this study is that following 7 days treatment with rifampicin, a known CYP450 inducer, the genetic variability in regulatory elements controlling CYP2C9 expression will be associated with the magnitude of change in INR response to warfarin and in CYP2C9-mediated warfarin metabolism.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Rifampicin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : July 2011
Estimated Primary Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Rifampin

Arm Intervention/treatment
Experimental: Rifampicin
Consecutive treatments with rifampicin and placebo
Drug: Rifampicin
oral, 450 mg/day , 7 days

Primary Outcome Measures :
  1. International Normalized Ratio (INR) [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Warfarin concentration [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy subjects

Exclusion Criteria:

  • Consumption of any medication during 30 days
  • Smoking
  • Alcohol consumption

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): NCT01388075

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Contact: Mordechai Muszkat, MD 972-6777111 ext 73793

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Hadassah Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel, 91120
Contact: Mordechai Muszkat, MD    972-2-6777111 ext 73793   
Principal Investigator: Mordechai Muszkat, MD         
Sponsors and Collaborators
Hadassah Medical Organization

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Responsible Party: Mordechai Muszkat, MD, Hadassah Medical Organization Identifier: NCT01388075     History of Changes
Other Study ID Numbers: HMO-0451-10
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: July 2011
Keywords provided by Hadassah Medical Organization:
Genetic variability
Additional relevant MeSH terms:
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Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers