Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism
Public ClinicalTrials.gov record NCT00291330. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.
Study identification
- NCT ID
- NCT00291330
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,564 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2006 (Type not available)
- Primary completion
- May 2009 (Actual)
- Completion
- Not listed
- Last update posted
- Jun 6, 2014
Started 2006
United States locations
- U.S. sites
- 23
- U.S. states
- 17
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 1160.53.01035 Boehringer Ingelheim Investigational Site | Mobile | Alabama | — | — |
| 1160.53.01056 Boehringer Ingelheim Investigational Site | Hartford | Connecticut | — | — |
| 1160.53.01044 Boehringer Ingelheim Investigational Site | Clearwater | Florida | — | — |
| 1160.53.01033 Boehringer Ingelheim Investigational Site | Sarasota | Florida | — | — |
| 1160.53.01046 Boehringer Ingelheim Investigational Site | Sarasota | Florida | — | — |
| 1160.53.01019 Boehringer Ingelheim Investigational Site | Augusta | Georgia | — | — |
| 1160.53.01008 Boehringer Ingelheim Investigational Site | Decatur | Georgia | — | — |
| 1160.53.01010 Boehringer Ingelheim Investigational Site | Marietta | Georgia | — | — |
| 1160.53.01014 Boehringer Ingelheim Investigational Site | Baltimore | Maryland | — | — |
| 1160.53.01023 Boehringer Ingelheim Investigational Site | Detroit | Michigan | — | — |
| 1160.53.01029 Boehringer Ingelheim Investigational Site | Pontiac | Michigan | — | — |
| 1160.53.01009 Boehringer Ingelheim Investigational Site | Saint Louis Park | Minnesota | — | — |
| 1160.53.01031 Boehringer Ingelheim Investigational Site | Lebanon | New Hampshire | — | — |
| 1160.53.01036 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico | — | — |
| 1160.53.01025 Boehringer Ingelheim Investigational Site | Valhalla | New York | — | — |
| 1160.53.01027 Boehringer Ingelheim Investigational Site | Chapel Hill | North Carolina | — | — |
| 1160.53.01039 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina | — | — |
| 1160.53.01030 Boehringer Ingelheim Investigational Site | Grand Forks | North Dakota | — | — |
| 1160.53.01013 Boehringer Ingelheim Investigational Site | Toledo | Ohio | — | — |
| 1160.53.01028 Boehringer Ingelheim Investigational Site | Portland | Oregon | — | — |
| 1160.53.01052 Boehringer Ingelheim Investigational Site | Altoona | Pennsylvania | — | — |
| 1160.53.01055 Boehringer Ingelheim Investigational Site | Summerville | South Carolina | — | — |
| 1160.53.01017 Boehringer Ingelheim Investigational Site | Richmond | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 227 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00291330, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 6, 2014 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00291330 live on ClinicalTrials.gov.