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NCT01802775 · ClinicalTrials.gov registry record · Phase 2
Edoxaban in Peripheral Arterial Disease
A Phase 2 study of Peripheral Arterial Disease, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 2
- Development phase
- 203
- Enrollment target
- 20
- Study locations
NCT01802775: Completed Phase 2 study of Peripheral Arterial Disease, sponsored by Daiichi Sankyo.
NCT01802775 is a Phase 2 study of Peripheral Arterial Disease that has completed, run by Daiichi Sankyo. The registered enrollment target is 203 participants, below the 4,204-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01802775, a Phase 2 study of Peripheral Arterial Disease, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 203 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is a randomized, open-label, blinded endpoint, parallel-group, active-control, multi-center, proof-of-concept study in subjects with Peripheral Arterial Disease (PAD), designed to assess the safety and potential efficacy of adding edoxaban to aspirin following femoropopliteal endovascular intervention, with or without stent placement, relative to current treatment practice with clopidogrel and aspirin.
Primary Outcome
Percentage of participants with clinically relevant bleeding, defined as major bleeding or clinical relevant non-major bleeding, in the on-treatment period based on International Society of Thrombosis and Haemostasis (ISTH)
Conditions Studied
Interventions
- DRUG Aspirin
- DRUG Clopidogrel
- DRUG edoxaban
Study Locations (20)
California
- - Beverly Hills
- - Los Angeles
- - Orange
Florida
- - Hollywood
- - Jacksonville
Michigan
- - Flint
- - Ypsilanti
North Carolina
- - Raleigh
- - Wilmington
Alabama
- - Birmingham
Arizona
- - Phoenix
Connecticut
- - New Haven
Illinois
- - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2013-02-06 |
| Est. Completion | 2014-12-03 |
| Phase | Phase 2 |
What the finished NCT01802775 record still lists
NCT01802775 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, below the 4,204-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 3 interventions - of which Aspirin is the first listed.
NCT01802775 names 20 study sites across 15 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT01802775 about?
NCT01802775 is a clinical study titled "Edoxaban in Peripheral Arterial Disease". This study is a randomized, open-label, blinded endpoint, parallel-group, active-control, multi-center, proof-of-concept study in subjects with Peripheral Arterial Disease (PAD), designed to assess the safety and potential efficacy of adding edoxaban to aspirin following femoropopliteal endovascular...
What is the current status of trial NCT01802775?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 203 participants. The study started on 2013-02-06. Estimated completion is 2014-12-03.
What conditions does trial NCT01802775 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease.
What interventions are being tested in trial NCT01802775?
The interventions under investigation include: Aspirin (DRUG), Clopidogrel (DRUG), edoxaban (DRUG).
Who is sponsoring clinical trial NCT01802775?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01802775 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01802775's enrollment target sits among peer trials
203 25th of 79 higher than 55 of 79 other Peripheral Arterial Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Arterial Disease 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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