Efficacy and Safety Trial With S 44819 After Recent Ischemic Cerebral Event

Recruiting

Phase 2 Results N/A

Update History

26 May '17
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
Inclusion criteria : - Patients aged between 18 and 85 years (both inclusive) - Acute ischemic stroke that occured between 72 hours (3 days) and 192 hours (8 days) (both inclusive) before inclusion Exclusion criteria : - Any non-selection criteria, which could have occurred after the selection visit - Positive urinary or blood pregnancy test (for female patients of child bearing potential) - Any clinically significant findings from the local laboratory test likely to interfere with the ability to participate in the study and / or with the study outcome - Severe renal impairment detected in the local laboratory test - Severe hepatic impairment or liver enzymes abnormalities found in the local laboratory test - Stroke due to cerebral venous thrombosis - Brain MRI showing a severe microangiopathy - Brain imaging showing an acute haemorrhagic stroke or a symptomatic haemorrhagic transformation of the brain infarct - Qualifying ischemic cerebral event older than 192 hours at inclusion - Any clinically relevant abnormalities detected during the examinations likely to interfere with study procedures or study outcome, - Repeated prolongation of ECG QTcF - Patient or authorised representative refusing to attend study visits or to take part in the study
Old
Inclusion criteria : - Patients aged between 18 and 80 years (both inclusive) - Acute ischemic stroke that occured at least 72 hours (3 days) and less than 144 hours (6 days) (both inclusive) before inclusion Exclusion criteria : - Any non-selection criteria, which could have occurred after the selection visit - Positive urinary or blood pregnancy test (for female patients of child bearing potential) - Any clinically findings from the local laboratory test likely to interfere with the ability to participate in the study and / or with the study outcome - Severe renal impairment detected in the local laboratory test - Severe hepatic impairment or liver enzymes abnormalities found in the local laboratory test - Stroke due to cerebral venous thrombosis - Brain MRI showing a severe microangiopathy - Brain MRI showing an acute lesion in brain stem or cerebellum - Brain imaging showing an acute haemorrhagic stroke or a symptomatic haemorrhagic transformation of the brain infarct - Qualifying ischemic cerebral event older than 144 hours at inclusion - Any clinically relevant abnormalities detected during the examinations likely to interfere with study procedures or study outcome, - Repeated prolongation of ECG QTcF - Patient or authorised representative refusing to attend study visits or to take part in the study
A location was updated in Adelaide.
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The overall status was updated to "Recruiting" at Royal Adelaide Hospital Department of Neurology.
A location was updated in Parkville.
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The overall status was updated to "Recruiting" at Royal Melbourne Hospital Department of Neurology.
A location was updated in Hasselt.
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The overall status was updated to "Recruiting" at Jessa Ziekenhuis Dienst Neurologie.
A location was updated in Leuven.
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The overall status was updated to "Recruiting" at UZ Leuven Campus Gasthuisberg.
A location was updated in Corbeil-essonnes.
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The overall status was updated to "Recruiting" at Hôpital Sud-Francilien.
A location was updated in Paris.
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The overall status was updated to "Recruiting" at Hôpital Sainte-Anne Neurologie.
A location was updated in Altenburg.
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The overall status was updated to "Recruiting" at Klinikum Altenburger Land GmbH Neurologische Klinik.
A location was updated in Essen.
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The overall status was updated to "Recruiting" at Universitaetsklinikum Essen Neurologische Universitätsklinik Essen.
A location was updated in Budapest.
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The overall status was updated to "Recruiting" at Semmelweis Egyetem Neurologiai Klinika.
A location was updated in Budapest.
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The overall status was updated to "Recruiting" at Szent Janos Korhaz Neurologiai osztaly.
A location was updated in Budapest.
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The overall status was updated to "Recruiting" at Honved Korhaz Stroke reszleg.
A location was updated in Miskolc.
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The overall status was updated to "Recruiting" at B-A-Z Megyei Korhaz es Egyetemi Oktato Korhaz Stroke, Er- es Neurologiai, Toxikologiai Osztaly.
A location was updated in Nyiregyhaza.
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The overall status was updated to "Recruiting" at Josa Andras Oktatokorhaz Neurologiai Osztaly.
A location was updated in Nijmegen.
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The overall status was updated to "Recruiting" at Canisius Wilhelmina Ziekenhuis Afdeling Neurologie.
A location was updated in Rotterdam.
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The overall status was updated to "Recruiting" at Erasmus MC Afdeling Neurologie.
A location was updated in Chelm.
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The overall status was updated to "Recruiting" at Samodzielny Publiczny Wojewodzki Szpital Specjalistyczny Oddzial Neurologiczny i Oddzial Udarowy.
A location was updated in Katowice.
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The overall status was updated to "Recruiting" at Samodzielny Publiczny Szpital Kliniczny nr7 SUM w Katowicach Oddzial Neurologii z Pododdzialem Udarowym.
A location was updated in Sandomierz.
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The overall status was updated to "Recruiting" at Szpital Specjalistyczny Ducha Swietego w Sandomierzu Oddzial Neurologii.
A location was updated in Warszawa.
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The overall status was updated to "Recruiting" at Instytut Psychiatrii i Neurologii II Klinika Neurologiczna.
A location was updated in Albacete.
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The overall status was updated to "Recruiting" at H. General de Albacete Servicio de Neurología.
A location was updated in Barcelona.
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The overall status was updated to "Recruiting" at H. del Mar Neurología.
A location was updated in Barcelona.
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The overall status was updated to "Recruiting" at H. Valle de Hebrón Servicio de Neurología.
A location was updated in Barcelona.
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The overall status was updated to "Recruiting" at H. Clinic i Provincial Servicio de Neurología.
A location was updated in Madrid.
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The overall status was updated to "Recruiting" at H. Ramón y Cajal Servicio de Neurología.
A location was updated in Bath.
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The overall status was updated to "Recruiting" at Royal United Hospital Older People's Unit.
A location was updated in Glasgow.
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The overall status was updated to "Recruiting" at Queen Elizabeth University Hospital.
A location was updated in Harrow.
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The overall status was updated to "Recruiting" at Northwick Park Hospital Neurology.
A location was updated in Leicester.
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The overall status was updated to "Recruiting" at Leicester Royal Infirmary Dpt of Neurology.
A location was updated in London.
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The overall status was updated to "Recruiting" at St George's Hospital Cardiology Department.
A location was updated in Nottingham.
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The overall status was updated to "Recruiting" at Nottingham City Hospital Division of Stroke Medicine.