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

Recruiting

Phase 2 Results N/A

Update History

31 Jan '18
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 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
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.