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NCT00398216 · ClinicalTrials.gov registry record · Phase 2
A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery
A Phase 2 study of Thrombosis and Hip Replacement, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 2
- Development phase
- 903
- Enrollment target
- 20
- Study locations
NCT00398216: Completed Phase 2 study of Thrombosis and Hip Replacement, sponsored by Daiichi Sankyo.
NCT00398216 is a Phase 2 study of Thrombosis and Hip Replacement that has completed, run by Daiichi Sankyo. The registered enrollment target is 903 participants, above the 438-participant average among 28 other Thrombosis trials with a reported enrollment target (106% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00398216, a Phase 2 study of Thrombosis and Hip Replacement, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 903 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits.
Primary Outcome
Assess the efficacy of DU-176b in the prevention of venous thromboembolism (VTE) from 6 to 8 hours after hip replacement surgery to 7 to 10 days after the surgery. A subject was judged to have a VTE if one or more of the following criteria were met: * Observed lower extremity deep vein thrombosis (DVT) (either proximal, distal, or both ) as assessed by bilateral or unilateral ascending contrast venography prior to or at the end-of-treatment (EOT) visit * Symptomatic and objectively proven pulm
Conditions Studied
Interventions
- DRUG DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor
Study Locations (20)
Other
- - Hellerup
- - Herlev
- - Hørsholm
- - Gyula
- - Kecskemét
- - Szeged
- - Riga
- - Krasnoyarsk
- - Moscow
- - Saint Petersburg
- - Saratov
- - Veliky Novgorod
Ontario
- - Ajax
- - Cambridge
- - Guelph
- - Kitchner
- - Toronto
Connecticut
- - Hartford
Florida
- - Sarasota
Texas
- - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 903 participants |
| Start Date | 2006-05 |
| Est. Completion | 2007-06 |
| Phase | Phase 2 |
What the finished NCT00398216 record still lists
NCT00398216 is an interventional study that assigns participants to a tested intervention. The registered 903 participants enrollment target is mid-sized for trials with a published cap, above the 438-participant average among 28 other Thrombosis trials with a reported enrollment target (106% higher).
The record links to 2 conditions, with Thrombosis appearing as the primary indexed condition, and to 1 intervention - of which DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor is the first listed.
NCT00398216 names 20 study sites across 5 states, led by Other, Ontario, Connecticut.
Frequently Asked Questions
What is clinical trial NCT00398216 about?
NCT00398216 is a clinical study titled "A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery". This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits.
What is the current status of trial NCT00398216?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 903 participants. The study started on 2006-05. Estimated completion is 2007-06.
What conditions does trial NCT00398216 study?
This clinical trial studies the following conditions: Thrombosis, Hip Replacement.
What interventions are being tested in trial NCT00398216?
The interventions under investigation include: DU176b - action is the prevention of venous thromboembolism by the use of a Factor Xa inhibitor (DRUG).
Who is sponsoring clinical trial NCT00398216?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00398216 being conducted?
This trial has 20 study locations across Connecticut, Florida, Texas, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00398216's enrollment target sits among peer trials
903 6th of 28 higher than 23 of 28 other Thrombosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Thrombosis 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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