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Dalteparin vs Unfractionated Heparin for VTE Prevention in Acutely Ill Medical Patients
NCT00445328Phase 4
Key facts
- Status
- Terminated
- Start
- Jun 2007
- Primary completion
- Jul 2008
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- dalteparin
- Conditions
- venous thromboembolism (VTE)
01
Overview
Phase 4, randomised, open-label trial of dalteparin in venous thromboembolism (VTE) (2 arms), sponsored by Pfizer. Primary endpoints: Confirmed Thromboembolic Events at Day 21 and Composite of Objectively Verified Thromboembolic Events at Day 21. Started Jun 2007; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Dalteparin
Dalteparin 5000 IU once daily subcutaneously
Unfractionated heparin
Unfractionated heparin 5000 IU thrice daily subcutaneously
03
Who it enrols
Adult patients hospitalized for acute medical conditions (heart failure, respiratory failure, infection, IBD, rheumatic disorders) with projected hospitalization >= 4 days and reduced mobility.
04
Endpoints
Primary
Confirmed Thromboembolic Events
Composite of Objectively Verified Thromboembolic Events
Secondary
All Cause Mortality
Stroke - Ischemic or Hemorrhagic
Bleeding - Major or Minor
Allergic Reactions (Drug-related)
Thrombocytopenia
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