NCT01178502

Brief Summary

To develop and validate the predictive warfarin dosing algorithm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
405

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

2.1 years

First QC Date

August 9, 2010

Last Update Submit

May 30, 2013

Conditions

Heart Valve Diseases

Outcome Measures

Primary Outcomes (1)

  • To Develop and Validate the Predictive Warfarin Dosing Algorithm

    1 year

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

the patients taking warfarin

You may qualify if:

  • the patients taking warfarin

You may not qualify if:

  • noncompliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University

Busan, 614-735, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples were taken from patients for genotyping about 8ml

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Pharmacology and Pharmacogenomics Research Center

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 10, 2010

Study Start

March 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations

KR(1)