EUCTR2005-003783-27-AT进行中（未招募）不适用
TOLERABILITY OF ENECADIN (INN) IN ACUTE ISCHEMIC STROKE TRIAL - TEST- PHASE IIA : A multicentre, double-blind, randomised, placebo-controlled, dose-escalating parallel- group study to investigate the tolerability of enecadin (INN) in acute ischemic stroke - TEST
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
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
- •1.Patients able to understand trial related information, scope of the trial and consequences of trial participation and to give Informed Consent. If the patient is unable to write, Informed Consent can be given orally and documented by an impartial witness.
- •2.The patient is male of female and aged between 18 and 85 years (extremes included) (in Austria according to local legislation)
- •3.Treatment onset within 9 hours after onset of stroke symptoms.
- •If the exact onset of stroke is unclear, but the onset of stroke symptoms was definitely less than 8 hours before arrival at the hospital, then the patient can be considered eligible for the study (this provides 1 hour for eligibility determination prior to receipt of randomised therapy).
- •4.Score of 3-20 on the NIHSS with clinical signs suggestive of ischemic stroke; level of consciousness score: 0 or 1 (conscious patients).
- •5.For female patients: post-menopausal or surgically sterile (post-menopausal: age = 55 years and last menses =3 years ago).
- •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
- •1.Participation in any investigational study in the previous 30 days.
- •2.Any terminal illness that is serious or advanced (patient is not expected to survive more than 1 year).
- •3.Patients unable to understand trial related information.
- •4.History, clinical presentation or suspicion of intracerebral haemorrhage (ICH), subarachnoid haemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. CT/MRI scan consistent with haemorrhagic stroke.
- •5.Suspected acute basilar artery occlusion.
- •6.Stroke or a serious head injury in the previous 6 weeks.
- •7.Spontaneously improving neurological signs since stroke onset.
- •8.Seizure at the onset of stroke.
- •9.QTcF interval >450 ms, history of drug-induced Torsade de Pointes, or presence of a familial long QT syndrome.
- •10.Bradycardia less than 50 bpm.
- •11.Resting pulse >110 bpm after at least 3 min rest.
- •12.History or evidence of clinically relevant arrhythmias (atrial fibrillation, frequent or complex ventricular extrasystoles, ventricular tachycardia, ventricular pre-excitation syndromes).
- •13.Significant cardiac conduction disturbances (AV block grades 2 and 3), complete right or left bundle branch block.
- •14.Patients with an implanted pacemaker.
- •15.Myocardial infarction within the previous 3 months
- •16.Any unstable or severe heart disease (e.g. clinically overt heart failure (NYHA III-IV), unstable angina pectoris).
- •17.Severe chronic uncontrolled arterial hypertension.
- •18.Relevant serum hypokalemia (< 3.6 mmol/L).
- •19.Acute uncontrolled hypertension defined by a blood pressure >220 mmHg systolic or >110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to values within the limits.
- •The definition of aggressive treatment” is left to the discretion of the responsible Investigator.
- •20.Relevant hepatic dysfunction (total bilirubin >1.8 mg/dL or 30 µmol/L, ALT, AST or GGT >3x the upper limit)
- •21.Known hypersensitivity to the study drug or components of the preparation.
- •22.Use of concomitant and prior medications as defined in section 11.2 (e.g. drugs prolonging myocardial repolarization (e.g. Class IA and Class III antiarrhythmic agents (amiodarone, sotalol, quinidine), antibiotics known to prolong the QT interval (e.g. macrolides), antipsychotics known to polong the QT interval).
- •23.Any other condition that could to the discretion of the Investigator impose hazards to the patient if study therapy was initiated, including clinically important deviations from the normal ranges of the assessed laboratory parameters.
研究者
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