ClinicalTrials.gov
ClinicalTrials.gov Menu

PGx Study to Develop and Validate the Predictive Warfarin Dosing Algorithm for Personalized Warfarin Pharmacotherapy

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.
ClinicalTrials.gov Identifier: NCT01178502
Recruitment Status : Completed
First Posted : August 10, 2010
Last Update Posted : June 3, 2013
Sponsor:
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University

Brief Summary:
To develop and validate the predictive warfarin dosing algorithm.

Condition or disease
Heart Valve Diseases

Detailed Description:
This study aims to develop and validate the predictive warfarin dosing algorithm for personalized warfarin pharmacotherapy in Korean patients.

Study Type : Observational
Actual Enrollment : 405 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Warfarin Dosing Algorithm for Personalized Warfarin Pharmacotherapy in Korean Patients
Study Start Date : March 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. To Develop and Validate the Predictive Warfarin Dosing Algorithm [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Blood samples were taken from patients for genotyping about 8ml


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
the patients taking warfarin
Criteria

Inclusion Criteria:

  • the patients taking warfarin

Exclusion Criteria:

  • noncompliance

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 ClinicalTrials.gov identifier (NCT number): NCT01178502


Locations
Korea, Republic of
Inje University
Busan, Korea, Republic of, 614-735
Sponsors and Collaborators
Inje University

Responsible Party: Jae-Gook Shin, Department of Pharmacology and Pharmacogenomics Research Center, Inje University
ClinicalTrials.gov Identifier: NCT01178502     History of Changes
Other Study ID Numbers: 09-025
First Posted: August 10, 2010    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Warfarin
Anticoagulants