Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Novartis Pharmaceuticals |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00311753 |
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 (LMWH) are thought to be effective in preventing thromboembolic events. This study is designed to provide efficacy and safety data for thromboprophylaxis with the LMWH certoparin in comparison to thromboprophylaxis with UFH in acutely ill non-surgical patients.
Condition | Intervention | Phase |
---|---|---|
Embolism |
Drug: Certoparin Drug: Heparin |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | An Open-Label Comparison of the Efficacy and Safety of the Low-Molecular-Weight Heparin (3000 U Anti-Xa Once Daily) With Unfractionated Heparin for the Prevention of Thromboembolic Complications in Acutely Ill Non-Surgical Patients |
Enrollment: | 342 |
Study Start Date: | February 2006 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Certoparin
|
Drug: Certoparin
Low-molecular-weight heparin, Certoparin (3000 U anti-Xa once daily) treatment period of 10 ± 2 days
|
2: Active Comparator
Heparin
|
Drug: Heparin
7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days
|
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Germany | |
Investigative Centers, Germany | |
Switzerland | |
Novartis Pharmaceuticals | |
Basel, Switzerland |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CMEX839BDE02 |
Study First Received: | April 4, 2006 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00311753 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
heparin, thromboprophylaxis, medical patients, acutely ill Acutely ill non surgical patients Immobilization |
Anticoagulants Heparin, Low-Molecular-Weight Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Thrombosis Calcium heparin |
Body Weight Calcium, Dietary Embolism and Thrombosis Fibrin Modulating Agents Embolism Heparin Certoparin |
Anticoagulants Molecular Mechanisms of Pharmacological Action Heparin, Low-Molecular-Weight Hematologic Agents Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |
Calcium heparin Embolism and Thrombosis Fibrin Modulating Agents Embolism Therapeutic Uses Cardiovascular Diseases Heparin Certoparin |