PraxbindTM India PMS Program

Thromboembolism Clinical Trial

Official title:

Post Marketing Surveillance Program of Praxbind Use in India.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359889
• Other study ID #: 1321-0023
• Status: Completed
• Start date: December 26, 2018
• Est. completion date: January 13, 2020

Study information

• Verified date: August 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 13, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

-Participation in a PraxbindTM clinical trial

Related Conditions & MeSH terms

• Thromboembolism

Intervention

Drug:
• PraxbindTM
Drug

Locations

Country	Name	City	State
India	Mazumdar Shaw Medical centre	Bangalore
India	Columbia Asia Referral Hospital	Bengaluru
India	Care Hospital	Hyderabad

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Patients Who Received Praxbind® Either for Emergency Surgery/Urgent Procedures or for Life-threatening or Uncontrolled Bleeding	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®.

External Links

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