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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jae-Gook Shin, Inje University
ClinicalTrials.gov Identifier:
NCT01178502
First received: August 9, 2010
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

To develop and validate the predictive warfarin dosing algorithm.


Condition
Heart Valve Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Warfarin Dosing Algorithm for Personalized Warfarin Pharmacotherapy in Korean Patients

Resource links provided by NLM:


Further study details as provided by Inje University:

Primary Outcome Measures:
  • To Develop and Validate the Predictive Warfarin Dosing Algorithm [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples were taken from patients for genotyping about 8ml


Enrollment: 405
Study Start Date: March 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

the patients taking warfarin

Criteria

Inclusion Criteria:

  • the patients taking warfarin

Exclusion Criteria:

  • noncompliance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178502

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

No publications provided

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
Study First Received: August 9, 2010
Last Updated: May 30, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014