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Sponsored by: |
LEO Pharma |
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Information provided by: | LEO Pharma |
ClinicalTrials.gov Identifier: | NCT00277394 |
The objective of the study is to compare the safety of innohep® and UFH in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute DVT.
The primary response criterion is the percentage of patients with clinically relevant bleeding events prior to day 90 +/- 5.
Condition | Intervention | Phase |
---|---|---|
Deep Vein Thrombosis |
Drug: LMWH (Innohep®) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | Safety Profile of Innohep Versus Subcutaneous Unfractionated Heparin in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis |
Enrollment: | 542 |
Study Start Date: | December 2005 |
Study Completion Date: | July 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Bulgaria | |
Bulgaria - managed by CRO | |
Sofia, Bulgaria | |
Croatia | |
Croatia - managed by CRO | |
Zagreb, Croatia | |
Czech Republic | |
Czech Republic - managed by CRO | |
Praha, Czech Republic | |
France | |
Hôpital de la Cavale Blanche | |
Brest, France, 29609 | |
Germany | |
Med. Klinik IV/Klinikum Darmstadt | |
Darmstadt, Germany, 64297 | |
Poland | |
Klinika Chirugii Naczyniowej | |
Szczecin, Poland, 70-111 | |
Romania | |
Romania - managed by CRO | |
Bucharest, Romania, 010965 | |
Serbia | |
Clinical Center Serbia, Institute of Cardiovascular diseases & Centre for Vascular Surgery-Belgrade | |
Belgrade, Serbia, 11000 | |
Spain | |
Service of Geriatry, Hospital Universitario Clínico San Carlos | |
Madrid, Spain, 28040 |
Principal Investigator: | Alain Leizorovicz, MD | Faculté de Médecine Laënnec |
Study ID Numbers: | IN 0401 INT |
Study First Received: | January 13, 2006 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00277394 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Denmark: Danish Medicines Agency; Spain: Spanish Agency of Medicines; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Bulgaria: Bulgarian Drug Agency; Czech Republic: State Institute for Drug Control; Croatia: Ministry of Health and Social Care; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romania: National Medicines Agency; Serbia and Montenegro: Agency for Drugs and Medicinal Devices |
Acute, symptomatic and objectively confirmed DVT |
Embolism and Thrombosis Embolism Heparin, Low-Molecular-Weight Tinzaparin Vascular Diseases |
Venous Thrombosis Heparin Thrombosis Calcium heparin |
Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Venous Thrombosis Thrombosis |