Status:
COMPLETED
A Comparison of Certoparin and Unfractionated Heparin in the Prevention of Thromboembolic Events in Acutely Ill Medical Patients
Lead Sponsor:
Novartis
Conditions:
Thromboembolism
Eligibility:
All Genders
70+ years
Phase:
PHASE3
Brief Summary
This study is designed to provide efficacy and safety data for certoparin in the prophylaxis of venous thromboembolism in immobilized, acutely ill medical patients.
Eligibility Criteria
Inclusion
- Hospitalized medical patients 70 years of age or older
- Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances)
- written informed consent
Exclusion
- immobilization longer than 3 days prior to randomization
- prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system
- expected major surgical or invasive procedure within the next 3 weeks after randomization
- LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization
- immobilization due to cast or fracture
- indication for anticoagulatory or thrombolytic therapy
- acute symptomatic DVT / PE
- known hypersensitivity to any of the study drugs or drugs with similar chemical structures
- Acute or history of heparin induced thrombocytopenia type II (HIT II)
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
3254 Patients enrolled
Trial Details
Trial ID
NCT00451412
Start Date
January 1 2007
End Date
June 1 2009
Last Update
July 25 2012
Active Locations (1)
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1
Novartis investigative sites
Nuremberg, Germany