EUCTR2004-001729-11-CZ进行中（未招募）1 期
A prospective, randomised, placebo controlled, double blind trial about safety and efficacy of combined treatment with Alteplase (rt-PA) and Cerebrolysin(R) in acute ischemic hemispehric stroke - CERE-LYSE-1
EBEWE Pharma GesmbH Nfg.KG0 个研究点目标入组 0 人开始时间: 2005年10月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female patients (18-80 years) with ischemic stroke not earlier then 3 hours before onset of thrombolytic treatment.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Evidence of intracranial haemorrhage (ICH) on the CT-scanl
- •Failure to perform or to evaluate screening or baseline examinations
- •Hospitalisation (except for study purposes) or change of concomitant medication 4 weeks prior to screening or during screening period
- •Participation in another therapeutic clinical trial 3 months before baseline
- •Patients with any history of prior stroke and concomitant diabetes
- •Prior stroke within the last 3 months
- •Platelet count of below 100x103/mm3
- •Blood glucose <50 or >400 mg/dl (<2.77 or >22.15 mmol/L)
- •Known haemorrhagic diathesis
- •Manifest or recent severe or dangerous bleeding
- •Known bacterial endocarditis, pericarditis
- •Acute pancreatitis
- •Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal
- •varices, arterial-aneurysm, arterial/venous malformation
- •Neoplasm with increased bleeding risk
- •Severe liver disease, including hepatic failure, cirrhosis, portal hypertension, oesaphageal
- •varices) and active hepatitis
- •Major surgery or significant trauma in past 3 months
- •Serious drug allergies
- •Hypersensitivity to one of the components of the drug
- •Severe renal impairment
研究者
相似试验
进行中（未招募）
1 期
A prospective, randomised, placebo controlled, double blind trial about safety and efficacy of combined treatment with Alteplase (rt-PA) and Cerebrolysin(R) in acute ischemic hemispehric stroke - CERE-LYSE-1EUCTR2004-001729-11-SKEBEWE Pharma GesmbH Nfg.KG
进行中（未招募）
不适用
A prospective, randomised, placebo controlled, double blind trial about safety and efficacy of combined treatment with Alteplase (rt-PA) and Cerebrolysin in acute ischemic hemispheric stroke - CERE-LYSE-1Clinical diagnosis of ischemic stroke causing a measurable neurological deficitdefined as impairment of language, motor function, cognition and/or gaze,vision or neglect. Ischemic stroke is defined as an event characterised by thesudden onset of an acute focal neurologic deficit presumed to be due tocerebral ischemia after CT scan excludes haemorrhage. Onset of symptoms within 3 hours prior to initiation of rt-PA administrationMedDRA version: 6.0Level: LLTClassification code 10055221EUCTR2004-001729-11-SIEBEWE Pharma Ges.m.b.H Nfg.KG108
进行中（未招募）
不适用
A prospective, randomised, placebo controlled, double blind trial about safety and efficacy of combined treatment with Alteplase (rt-PA) and Cerebrolysin in acute ischemic hemispheric stroke - CERE-LYSE-1EUCTR2004-001729-11-ATEBEWE Pharma Ges.m.b.H Nfg.KG108
进行中（未招募）
1 期
A prospective, randomised, placebo-controlled, double blind, multi-centre study of the effects of Irbesartan on aortic dilatation in Marfan syndromeMarfan SyndromeEUCTR2010-019302-16-GBRoyal Brompton and Harefield NHS Foundation Trust490
已完成
3 期
A prospective, randomized, placebo-controlled, double-blind, cross-over study of the usefulness of sustained-release opioids in the subjective sensation of dyspnoea secondary to advanced disease with no reversible components in opioid naive patients.Opioids in Refractory dyspnoeaRespiratory - Other respiratory disorders / diseasesACTRN12607000075482Repatriation General Hospital48