PraxbindTM India PMS Program
Post Marketing Surveillance Program of Praxbind Use in India.
1 other identifier
observational
5
1 country
3
Brief Summary
This program will be initiated after the commercial availability of PraxbindTM in India. It will include patients administered with PraxbindTM into the surveillance program after commercial availability in 2 years at selected centres approved by the regulatory authority.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2018
3 active sites
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
First Submitted
Initial submission to the registry
November 28, 2017
CompletedFirst Posted
Study publicly available on registry
December 2, 2017
CompletedStudy Start
First participant enrolled
December 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2020
CompletedResults Posted
Study results publicly available
February 16, 2021
CompletedAugust 25, 2023
August 1, 2023
1 year
November 28, 2017
January 13, 2021
August 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs)
Number of participants with suspected adverse drug reactions (ADRs) and fatal adverse events (AEs) occurring within 7 days after Praxbind® administration.
Up to 7 days following treatment.
Secondary Outcomes (1)
Percentage of Patients Who Received Praxbind® Either for Emergency Surgery/Urgent Procedures or for Life-threatening or Uncontrolled Bleeding
Data collected from patients who had been treated with Praxbind® within 2 years of the commercial availability of Praxbind®.
Study Arms (1)
patients administered with PraxbindTM
Interventions
Eligibility Criteria
All patients, who receive PraxbindTM prescribed as per the approved label
You may qualify if:
- \- Patients treated with Pradaxa (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran: For emergency surgery/urgent procedures (or) In life-threatening or uncontrolled bleeding
- \- Written informed consent in accordance with International Conference on Harmonization Good Clinical Practice (GCP) guidelines and local legislation and/or regulations
You may not qualify if:
- Participation in a PraxbindTM clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Mazumdar Shaw Medical centre
Bangalore, 560099, India
Columbia Asia Referral Hospital
Bengaluru, 560055, India
Care Hospital
Hyderabad, 500034, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2017
First Posted
December 2, 2017
Study Start
December 26, 2018
Primary Completion
January 13, 2020
Study Completion
January 13, 2020
Last Updated
August 25, 2023
Results First Posted
February 16, 2021
Record last verified: 2023-08