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Bemiparin vs Enoxaparin in Acute DVT
NCT01880216Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2013
- Primary completion
- Jan 2015
- Countries
- 2
- Sponsor
- Menarini Group
- Modality
- Small Molecules
- Drugs
- bemiparin
- Conditions
- deep vein thrombosis (DVT)
01
Overview
Phase 3, randomised, open-label trial of bemiparin in deep vein thrombosis (DVT) (2 arms), sponsored by Menarini Group. Primary endpoint: Percentage of patients with an improvement in thrombotic burden at Day 83. Started Jun 2013; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Bemiparin sodium
Bemiparin sodium s.c. daily for 7+/-2 days + Warfarin
Enoxaparin sodium
Enoxaparin sodium s.c. for 7+/-2 days + Warfarin
03
Who it enrols
Patients with acute deep-vein thrombosis of the leg (DVT) with symptoms of less than 14 days. Exclusion criteria include history of HIT, platelet count < 100,000/mm3, uncontrolled arterial hypertension (systolic > 200 mmHg), severe pancreas impairment, and significant liver disease.
04
Endpoints
Primary
Percentage of patients with an improvement in thrombotic burden
Secondary
Incidence of symptomatic venous thromboembolic events (VTE)
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