N/A
N=5
PraxbindTM India PMS Program
Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT03359889 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs) — 0; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PraxbindTM (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs) |
0; 0 | — |
| SECONDARY Percentage of Patients Who Received Praxbind® Either for Emergency Surgery/Urgent Procedures or for Life-threatening or Uncontrolled Bleeding |
20; 80 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03359889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.