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A Study in the United Sates That Looks at the Safety and Effectiveness of Pradaxa Pellets in Children Aged 3 Months to Less Than 12 Years Who Need Treatment of a Blood Clot or Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot

A Study in the United Sates That Looks at the Safety and Effectiveness of Pradaxa Pellets in Children Aged 3 Months to Less Than 12 Years Who Need Treatment of a Blood Clot or Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot

Non Recruiting
3-12 years
All
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  • Written informed consent from parents/care givers and patient assent if age appropriate
  • Initiation of Pradaxa Pellets administration either as initial or subsequent therapy:
    • Treatment of venous thromboembolic events (VTE)
    • Treatment to reduce the risk of recurrence of VTE

Exclusion Criteria:

  • Participation in any randomized clinical trial or use of investigational product, participation in any other observational study is not an exclusion
  • Any contraindications to Pradaxa Pellets according to the US Prescribing Information.
  • Previous participation in this study.

Study details
    Venous Thromboembolism

NCT05966740

Boehringer Ingelheim

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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