Conditions: Venous Thromboembolism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1353
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Patient to receive dabigatran etexilatate capsules 150 mg twice daily arm 2: Patient to receive dabigatran extexilate matching placebo capsules twice daily

Interventions: intervention 1: dabigatran etexilate 150 mg twice daily (BID) intervention 2: matching placebo twice daily (BID)
Intervention descriptions: intervention 1: dabigatran etexilate capsules 150 mg BID intervention 2: Matching placebo BID

Protocol document: