Efficacy and safety trial with S 44819 after recent ischemic cerebral event

Phase 1

• Conditions: Post stroke recovery; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 19.0 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2016-001005-16-ES
• Lead Sponsor: aboratorios Servier S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-26
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 580

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 145
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 435

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
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified