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NCT00657150 · ClinicalTrials.gov registry record · Phase 3
Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,055
- Enrollment target
NCT00657150: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00657150 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 2,055 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (166% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00657150, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,055 participants
- Enrollment target
Study Summary
The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and efficacy will be compared between the treatment groups.
Primary Outcome
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patie
Interventions
- DRUG Enoxaparin
- DRUG Dabigatran etexilate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,055 participants |
| Start Date | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00657150 record still lists
NCT00657150 is an interventional study that assigns participants to a tested intervention. Its 2,055 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (166% higher).
The record links to 0 conditions, and to 2 interventions - of which Enoxaparin is the first listed.
NCT00657150 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00657150 about?
NCT00657150 is a clinical study titled "Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty". The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and efficacy will be compared between the treatment groups.
What is the current status of trial NCT00657150?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,055 participants. The study started on 2008-03.
What interventions are being tested in trial NCT00657150?
The interventions under investigation include: Enoxaparin (DRUG), Dabigatran etexilate (DRUG).
Who is sponsoring clinical trial NCT00657150?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00657150's enrollment target sits among peer trials
2,055 99th of 2000 higher than 1,902 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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