At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,353 enrolled
Drug / intervention
dabigatran etexilate 150 mg twice daily (BID) +1 moredrug
Likely dose
dabigatran etexilate 150 mg twice daily (BID)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism.
In Brief
A Phase 3 clinical trial evaluating dabigatran etexilate 150 mg twice daily (BID) and matching placebo twice daily (BID) for Venous Thromboembolism. Completed, enrolled 1,353 participants across 147 sites in 21 countries.
Detailed Summary
The primary efficacy objective is to evaluate whether dabigatran etexilate is superior to placebo in the long-term prevention of recurrent symptomatic venous thrombo-embolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 to 18 months of treatment with vitamin K antagonist (VKA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism
CountriesAustralia, Austria, Belgium, Canada, Czechia, Estonia, Germany, Italy, Latvia, Lithuania, Netherlands, New Zealand, Poland, Russia, Singapore, South Africa, South Korea, Sweden, Switzerland, Thailand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
First PostedNov 2007
Primary CompletionFeb 2011
TodayJul 2026
First PostedNov 14, 2007
Enrollment StartNov 1, 2007
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.6 years ago
Interventions
dabigatran etexilate 150 mg twice daily (BID)drug
dabigatran etexilate capsules 150 mg BID
matching placebo twice daily (BID)drug
Matching placebo BID