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EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis
NCT02309411 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.
Conditions Studied
Interventions
- DRUG Rivaroxaban (Xarelto, BAY59-7939)
Study Locations (20)
Other
- — Vienna
- — São Paulo
- — Budapest
- — Jerusalem
- — Ramat Gan
- — Nijmegen
- — Gdansk
- — Olsztyn
Florida
- — Gainesville
- — Pensacola
Georgia
- Children's Healthcare of Atlanta — Atlanta
Illinois
- — Chicago
Indiana
- — Indianapolis
Victoria
- — Parkville
São Paulo
- — São Paulo
Ontario
- — Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2015-01-15 |
| Est. Completion | 2017-04-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02309411
The ClinicalTrials.gov registry entry for NCT02309411 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Venous Thromboembolism appearing as the primary indexed condition, and to 1 intervention — of which Rivaroxaban (Xarelto, BAY59-7939) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02309411 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02309411 about?
NCT02309411 is a clinical study titled "EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis". The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.
What is the current status of trial NCT02309411?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2015-01-15. Estimated completion is 2017-04-05.
What conditions does trial NCT02309411 study?
This clinical trial studies the following conditions: Venous Thromboembolism. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02309411?
The interventions under investigation include: Rivaroxaban (Xarelto, BAY59-7939) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02309411?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02309411 being conducted?
This trial has 20 study locations across Florida, Georgia, Illinois, Indiana, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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