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NCT02047565 · ClinicalTrials.gov registry record · Phase 1
A Two-part Study in Edoxaban-treated Healthy Subjects to Establish a Punch Biopsy Bleeding Model and to Evaluate the Effect of a 4-factor Prothrombin Complex Concentrate on Anticoagulation
A Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
NCT02047565: Completed Phase 1 study, sponsored by Daiichi Sankyo.
NCT02047565 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 110 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02047565, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
Study Summary
This Phase 1 study consists of 2 parts. Part 1 will be an open-label, randomized, 2 treatment, 2-way crossover study. Part 2 will be a double-blind (Sponsor unblinded), randomized, placebo controlled, sequential descending prothrombin complex concentrate dose, 2 sequence, 2 period crossover study. In both parts of the study, the assessor of BD and BV will remain blinded. In Part 2 of the study, both the subject and the clinic staff involved in study conduct will be blinded (with the exception of the pharmacist or nurse who prepares the blinded individual treatments from open-label supplies). The study programmer and statistician will also be blinded to treatment assignment. The Sponsor will remain unblinded for both parts of the study.
Primary Outcome
To assess the variability and effect size of bleeding duration (BD) following punch biopsy in healthy subjects administered 60 mg edoxaban
Interventions
- DRUG 60mg edoxaban
- DRUG 180mg edoxaban
- DRUG 50 IU/kg Beriplex P/N
- DRUG 25 IU/kg Beriplex P/N
- DRUG 10 IU/kg Beriplex P/N
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT02047565 record still lists
NCT02047565 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% higher).
The record links to 0 conditions, and to 5 interventions - of which 60mg edoxaban is the first listed.
NCT02047565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02047565 about?
NCT02047565 is a clinical study titled "A Two-part Study in Edoxaban-treated Healthy Subjects to Establish a Punch Biopsy Bleeding Model and to Evaluate the Effect of a 4-factor Prothrombin Complex Concentrate on Anticoagulation". This Phase 1 study consists of 2 parts. Part 1 will be an open-label, randomized, 2 treatment, 2-way crossover study. Part 2 will be a double-blind (Sponsor unblinded), randomized, placebo controlled, sequential descending prothrombin complex concentrate dose, 2 sequence, 2 period crossover study. I...
What is the current status of trial NCT02047565?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2013-10. Estimated completion is 2014-05.
What interventions are being tested in trial NCT02047565?
The interventions under investigation include: 60mg edoxaban (DRUG), 180mg edoxaban (DRUG), 50 IU/kg Beriplex P/N (DRUG), 25 IU/kg Beriplex P/N (DRUG), 10 IU/kg Beriplex P/N (DRUG).
Who is sponsoring clinical trial NCT02047565?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02047565's enrollment target sits among peer trials
110 514th of 2000 higher than 1,479 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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