Safety and effectiveness of Pradaxa oral pellet formulation for treatment of acute venous thromboembolic events (VTE) and/or for risk reduction of recurrence of VTE in pediatric patients aged 3 months to less than 12 years in a real world setting: a prospective non-interventional study conducted in the United States

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000981
• Study ID:
  1000000981
• Official title and acronym:
  Safety and effectiveness of Pradaxa oral pellet formulation for treatment of acute venous thromboembolic events (VTE) and/or for risk reduction of recurrence of VTE in pediatric patients aged 3 months to less than 12 years in a real world setting: a prospective non-interventional study conducted in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The main research question of this study is to obtain further safety and effectiveness data on Pradaxa Pellets in children aged 3 months to less than 12 years in routine clinical practice setting.
• Study status:
  Discontinued

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Actual:12/11/2021

Study start date

Actual:19/04/2024

Date of final study report

Actual:06/11/2025

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

1160-0309
NCT05966740