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Sponsored by: |
LEO Pharma |
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Information provided by: | LEO Pharma |
ClinicalTrials.gov Identifier: | NCT00742482 |
The purpose of the study is to evaluate the efficacy and safety of three doses of HL 10 given at fixed time intervals compared to standard therapy
Condition | Intervention | Phase |
---|---|---|
Acute Lung Injury Acute Respiratory Distress Syndrome |
Drug: HL 10 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Study With Freeze Dried HL10, Three Dosages of 200 mg/kg Ideal Body Weight Versus Standard Therapy in ALI/ARDS Patients |
Enrollment: | 418 |
Study Start Date: | January 2003 |
Study Completion Date: | June 2005 |
Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Allgemeines Krankenhaus, Klinik für Anästhesie un Allgemeine Intensivmedizin | |
Wien, Austria, 1090 | |
Belgium | |
Erasme University Hospital | |
Brussels, Belgium, 1070 | |
Canada, Ontario | |
Mount Sinai Hospital, Critical Care Unit | |
Toronto, Ontario, Canada, M5G 1X5 | |
Denmark | |
Odense University Hospital | |
Odense C, Denmark, 5000 | |
Finland | |
Kuopio University Hospital, Intensive Care Unit | |
Kuopio, Finland, 70211 | |
France | |
Hôpital Pitié Salpétrière, Département d'Anesthésie Réanimation | |
Paris, France, 75651 | |
Germany | |
Klinik für Anästhesiologie der RWTH Aachen | |
Aachen, Germany, 52074 | |
Netherlands | |
Department of Intensive Care Medicine | |
Utrecht, Netherlands, 3584 | |
Academisch Medisch Centrum | |
Amsterdam, Netherlands, 1005 | |
Norway | |
Ullevål University Hospital, INtensive Care Department | |
Oslo, Norway, 0407 | |
Spain | |
Consorci Hospitalari Parc Taulí | |
Sabadell (Barcelona), Spain, 08208 | |
Sweden | |
University Hospital of Lund, Department of Intensive Care | |
Lund, Sweden, 221 85 | |
United Kingdom | |
St Thomas Hospital, Adult Intensive Care | |
London, United Kingdom, SE1 7EH |
Principal Investigator: | Jozef Kesecioglu, MD, PhD | Anaesthesist-Intensivist, Department of Intensive Care Medicine |
Responsible Party: | LEO Pharma A/S ( Edmée Steenken/Project Co-ordinator ) |
Study ID Numbers: | HL 0101 INT |
Study First Received: | August 26, 2008 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00742482 |
Health Authority: | Austria: Agency for Health and Food Safety; Belgium: Directorate general for the protection of Public health: Medicines; Canada: Health Canada; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: Dutch Health Care Inspectorate; Norway: Norwegian Medicines Agency; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Body Weight Respiratory Tract Diseases Lung Diseases |
Respiration Disorders Respiratory Distress Syndrome, Adult Acute respiratory distress syndrome |
Pathologic Processes Disease Syndrome |