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NCT00152971 · ClinicalTrials.gov registry record · Phase 3

Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement

A Phase 3 study, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 3
Development phase
2,615
Enrollment target

NCT00152971: Completed Phase 3 study, sponsored by Boehringer Ingelheim.

NCT00152971 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 2,615 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (239% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00152971, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 3
Development phase
2,615 participants
Enrollment target

Study Summary

To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery

Primary Outcome

Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression 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 allocatio

Interventions

  • DRUG Enoxaparin
  • DRUG Dabigatran Dose 1 - day 2 to completion
  • DRUG Dabigatran Dose 1 - day 1
  • DRUG Dabigatran Dose 2 - day 2 to completion
  • DRUG Dabigatran Dose 2 - day 1

Trial Details

FieldValue
Enrollment Target 2,615 participants
Start Date 2004-11
Phase Phase 3
Boehringer Ingelheim

515 total trials

What the finished NCT00152971 record still lists

NCT00152971 is an interventional study that assigns participants to a tested intervention. Its 2,615 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 (239% higher).

The record links to 0 conditions, and to 5 interventions - of which Enoxaparin is the first listed.

NCT00152971 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00152971 about?

NCT00152971 is a clinical study titled "Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement". To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous ...

What is the current status of trial NCT00152971?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,615 participants. The study started on 2004-11.

What interventions are being tested in trial NCT00152971?

The interventions under investigation include: Enoxaparin (DRUG), Dabigatran Dose 1 - day 2 to completion (DRUG), Dabigatran Dose 1 - day 1 (DRUG), Dabigatran Dose 2 - day 2 to completion (DRUG), Dabigatran Dose 2 - day 1 (DRUG).

Who is sponsoring clinical trial NCT00152971?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00152971's enrollment target sits among peer trials

2,615 84th of 2000 higher than 1,917 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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Source: ClinicalTrials.gov NCT00152971, the US trial registry maintained by the National Library of Medicine. NCT00152971 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.