A Phase 3 interventional study of Certoparin and Heparin in Embolism, sponsored by Novartis Pharmaceuticals. Completed at 2 sites in 2 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-02-24.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Prevention
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.
707 studies on the registry are indexed under Embolism; 72 are open to participants now.
This study's enrollment of 342 is above the median of 130 across 364 interventional studies indexed under Embolism.
Browse Embolism studies →Novartis Pharmaceuticals is the lead sponsor of 2,711 studies on the registry; 218 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 435 (75%) have results posted.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Certoparin
Drug: Certoparin
Heparin
Drug: Heparin
Low-molecular-weight heparin, Certoparin (3000 U anti-Xa once daily) treatment period of 10 ± 2 days
7500 IU of unfractionated heparin administered twice daily during the treatment period of 10 ± 2 days
The occurrence of thromboembolic events (proximal or distal DVT, PE or VTE related death) during treatment
Time frame: 10 ± 2 days
Thromboembolic events during follow-up period of 3 months
Time frame: 90 days (± 7 days) after the end of the treatment
Safety endpoints occurring during the treatment period: Hemorrhage (major or minor), Thrombocytopenia, Symptomatic HIT type II, Induction of HIT-II specific antibodies
Time frame: 10 ± 2 days
The record gives a start of Feb 2006 and a primary completion of Dec 2007. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Certoparin