Status:
COMPLETED
Efficacy and Safety of Low-molecular Weight Heparin for Thromboprophylaxis in Acutely Ill Medical Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Embolism
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
Acutely ill immobilized patients are at a high risk for thromboembolic events including deep venous thrombosis or pulmonary embolism. Unfractionated heparin (UFH) and low molecular weight heparins (LM...
Eligibility Criteria
Inclusion
- Hospitalization due to an acute non-surgical disease
- Significant decrease in mobility
Exclusion
- Indication for anticoagulant or thrombolytic therapy
- Major surgical or invasive procedure within the 4 weeks that precede randomization
- Expected major surgical or invasive procedure (including spinal/peridural/epidural anesthesia or lumbar puncture) within the 2 weeks that follow the randomization
- Immobilization due to cast or fracture of lower extremity
- Immobilization lasting longer than 3 days in the period prior to randomization
- Heparin administration longer than 36 hours in the period prior to randomization
- Acute ischemic stroke
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT00311753
Start Date
February 1 2006
Last Update
February 24 2017
Active Locations (2)
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1
Investigative Centers, Germany
2
Novartis Pharmaceuticals
Basel, Switzerland