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NCT02303431 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study
A Phase 1 study of Venous Thromboembolism and Deep Vein Thrombosis, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 20
- Study locations
NCT02303431: Completed Phase 1 study of Venous Thromboembolism and Deep Vein Thrombosis, sponsored by Daiichi Sankyo.
NCT02303431 is a Phase 1 study of Venous Thromboembolism and Deep Vein Thrombosis that has completed, run by Daiichi Sankyo. The registered enrollment target is 66 participants, below the 6,295-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02303431, a Phase 1 study of Venous Thromboembolism and Deep Vein Thrombosis, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy to see what the body does to the drug (pharmacokinetics) and what the drug does to the body (pharmacodynamics), and to compare if these effects are similar to those observed in adults.
Primary Outcome
A model-based pooled population pharmacokinetic (PK) method was used to estimate systemic clearance (CL/F). As prespecified in the protocol, arms were pooled due to sparse PK samples being collected. the median PK estimate is reported in all participants at a total of 5 blood samplings.
Conditions Studied
Interventions
- DRUG Edoxaban low dose
- DRUG Edoxaban high dose
Study Locations (20)
Other
- Childrens Hospital of Eastern Ontario - Ottawa
- Hopital Arnaud de Villeneuve - Montpellier
- CHU Bordeaux - Hopital Haut-Leveque - Pessac
- Nirmal Hospital Pvt. Ltd - Gujrāt
- Institute of Child Health - Kolkata
- Christian Medical College and Hospital - Ludhiāna
- Istituto Giannina Gaslini - UOSD Emostasi e Trombosi - Genova
California
- University of California, Los Angeles (UCLA) - Los Angeles
- Lucile Packard Children's Hospital Stanford University - Palo Alto
Colorado
- University of Colorado Denver - Denver
Illinois
- Ann and Robert H. Lurie Children's Hospital of Chicago - Chicago
Indiana
- Indiana Hemophilia and Thrombosis Center - Indianapolis
Kentucky
- University of Louisville ; Kosair Charities Pediatric Clincial Research Unit - Louisville
North Carolina
- Duke University Medical Center (DUMC) - Durham
Ohio
- University Hospitals Case Medical Center - Rainbow Babies and Children's Hospital - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2014-11-05 |
| Est. Completion | 2021-09-16 |
| Phase | Phase 1 |
What the finished NCT02303431 record still lists
NCT02303431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 6,295-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Venous Thromboembolism appearing as the primary indexed condition, and to 2 interventions - of which Edoxaban low dose is the first listed.
NCT02303431 names 20 study sites across 13 states, led by Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT02303431 about?
NCT02303431 is a clinical study titled "Phase 1 Pediatric Pharmacokinetics/Pharmacodynamics (PK/PD) Study". This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy to see what the body does to the drug (pharmacokinetics) and what the drug does to the body (pharmacodynamics), and t...
What is the current status of trial NCT02303431?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2014-11-05. Estimated completion is 2021-09-16.
What conditions does trial NCT02303431 study?
This clinical trial studies the following conditions: Venous Thromboembolism, Deep Vein Thrombosis.
What interventions are being tested in trial NCT02303431?
The interventions under investigation include: Edoxaban low dose (DRUG), Edoxaban high dose (DRUG).
Who is sponsoring clinical trial NCT02303431?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02303431 being conducted?
This trial has 20 study locations across California, Colorado, Illinois, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02303431's enrollment target sits among peer trials
66 41st of 47 higher than 7 of 47 other Venous Thromboembolism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Venous Thromboembolism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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