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NCT02846532 · ClinicalTrials.gov registry record · Phase 3
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 112
- Enrollment target
NCT02846532 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 112 participants.
The verdict
NCT02846532, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 112 participants
- Enrollment target
Study Summary
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment (Part A) and to evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched to rivaroxaban 10 milligram \[mg\] once daily in adults) compared to acetylsalicylic acid (ASA), given once daily (approximately 5 milligram per kilogram \[mg/kg\]) for thromboprophylaxis in pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment.
Interventions
- DRUG Rivaroxaban
- DRUG Acetylsalicylic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2016-11-16 |
| Est. Completion | 2020-07-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02846532
The ClinicalTrials.gov registry entry for NCT02846532 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rivaroxaban is the first listed.
NCT02846532 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02846532 about?
NCT02846532 is a clinical study titled "Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure". The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8 years of age with single ventricle physiology who have completed the Fonta...
What is the current status of trial NCT02846532?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2016-11-16. Estimated completion is 2020-07-16.
What interventions are being tested in trial NCT02846532?
The interventions under investigation include: Rivaroxaban (DRUG), Acetylsalicylic Acid (DRUG).
Who is sponsoring clinical trial NCT02846532?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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