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NCT03359889 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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®.
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