EUCTR2007-007197-31-SE进行中（未招募）不适用
EFFECTS OF ORAL LEVOSIMENDAN ON AMBULATORY ELECTROCARDIOGRAPHICVARIABLES AND CEREBROVASCULAR REACTIVITY IN PATIENTS WITH RECENTSTROKE OR TIA. A RANDOMISED, DOUBLE BLIND, PLACEBO-CONTROLLED,DOSE FINDING, MULTICENTRE STUDY WITH PARALLEL GROUP DESIGN - ELECTRO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
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 50 to 80 years of age with ischaemic stroke or TIA within 1 to 9 months before the screening visit. Other inclusion criteria are:
- •Maintenance treatment with an angiotensin II receptor blocker or angiotensin converting enzyme inhibitor, cholesterol lowering agent (preferably 3-hydroxy-3-methyl-glutaryl-Coenzyme A [HMG-CoA] reductase inhibitor) and antiaggregatory agent, started at least 1 month before the screening visit.
- •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
- •Stroke or TIA due to cardiac embolism, vasculitis or arterial dissection
- •Severe hemiparesis or dysphasia inhibiting the ability to fully comply with the study protocol requirements
- •Haemodynamically significant uncorrected valve disease or hypertrophic cardiomyopathy or restrictive cardiomyopathy
- •Acute myocardial infarction or any other acute coronary event within 1 month before the screening visit
- •Cardiovascular surgery (e.g. carotid endarterectomy, coronary by-pass) or angioplasty or any other major surgery within 1 month before the screening visit
- •Patients who are scheduled for coronary by-pass or angioplasty, or carotid endarterectomy or any major surgery during the planned study period
- •History of life-threatening ventricular arrhythmia within 3 months before randomization defined as an episode of resuscitated sudden death, ventricular fibrillation (VF) or sustained or haemodynamically destabilising ventricular tachycardia (VT)
- •History of Torsades de Pointes (TdP) or family history of long QT-syndrome
- •Anticipated technical problems in transcranial Doppler (TCD) assessments (e.g. poor insonation of the temporal bone window, patient’s inability to hold breath for at least 30 seconds)
- •Heart rate (HR) < 50 or > 100 bpm in the 12-lead ECG or as an average in the 24-hour ambulatory Holter recording at screening
- •Systolic blood pressure (SBP) < 100 mmHg or > 180 mmHg, or diastolic blood pressure (DBP) > 100 mmHg at screening
- •Ventricular tachycardia (wide complex tachycardia > 100/min, = 3 consecutive beats) in the 24-hour ambulatory Holter recording at screening
- •Episode of atrial fibrillation or atrial flutter lasting > 60 seconds in 24-h ambulatory Holter recording at screening
- •Second or third degree atrioventricular (AV) block in the 12-lead ECG or in the 24-h ambulatory Holter recording at screening
- •Potassium (K) < 3.7 mmol/l or > 5.5 mmol/l at screening
- •Creatinine > 170 µmol/l at screening or on dialysis
- •Blood haemoglobin <10 g/dl at screening
- •Clinically significant hepatic impairment at the discretion of the investigator.
- •Women of reproductive age without a negative pregnancy test and without a commitment to using an acceptable method of barrier or hormonal contraception (e.g. condoms, diaphragms, oral contraceptives and long acting progestin agents) if sexually active during the study and for 1 month after the last dose of the study treatment. Women who are postmenopausal (1 year since last menstrual cycle), surgically sterilised or who have undergone a hysterectomy are considered not to be reproductive and can be included.
- •Other serious diseases limiting the life expectancy considerably (e.g. end-stage cancer).
- •Participation in a clinical trial with any experimental treatment within 30 days prior to the screening visit or previous participation in the present study.
- •Hypersensitivity to levosimendan.
- •Administration of levosimendan within 30 days prior to screening visit.
- •Any other condition that in the opinion of the investigator could create a hazard to the subject safety, or interfere with study procedures or with the interpretation of study results.
- •A predictable poor compliance or inability to communicate well with the study personnel.
研究者
相似试验
进行中（未招募）
不适用
EFFECTS OF ORAL LEVOSIMENDAN ON AMBULATORY ELECTROCARDIOGRAPHICVARIABLES AND CEREBROVASCULAR REACTIVITY IN PATIENTS WITH RECENTSTROKE OR TIA. A RANDOMISED, DOUBLE BLIND, PLACEBO-CONTROLLED,DOSE FINDING, MULTICENTRE STUDY WITH PARALLEL GROUP DESIGN - ELECTROStroke or TIAMedDRA version: 9.1Level: LLTClassification code 10042244Term: StrokeEUCTR2007-007197-31-HUOrion Corporation Orion Pharma45
进行中（未招募）
不适用
EFFECTS OF ORAL LEVOSIMENDAN ON AMBULATORY ELECTROCARDIOGRAPHICVARIABLES AND CEREBROVASCULAR REACTIVITY IN PATIENTS WITH RECENTSTROKE OR TIA. A RANDOMISED, DOUBLE BLIND, PLACEBO-CONTROLLED,DOSE FINDING, MULTICENTRE STUDY WITH PARALLEL GROUP DESIGN - ELECTROStroke or TIAMedDRA version: 9.1Level: LLTClassification code 10042244Term: StrokeEUCTR2007-007197-31-FIOrion Corporation Orion Pharma30
进行中（未招募）
不适用
EFFECTS OF ORAL LEVOSIMENDAN ON AMBULATORY ELECTROCARDIOGRAPHICVARIABLES AND CEREBROVASCULAR REACTIVITY IN PATIENTS WITH RECENTSTROKE OR TIA. A RANDOMISED, DOUBLE BLIND, PLACEBO-CONTROLLED,DOSE FINDING, MULTICENTRE STUDY WITH PARALLEL GROUP DESIGN - ELECTROStroke or TIAMedDRA version: 9.1Level: LLTClassification code 10042244Term: StrokeEUCTR2007-007197-31-DEOrion Corporation Orion Pharma30
已完成
2 期
Effects of Oral Levosimendan on Ambulatory Electrocardiographic VariablesStrokeTransient Ischemic AttackNCT00698763Orion Corporation, Orion Pharma32
进行中（未招募）
不适用
EFFECTIVENESS OF THE LEVOSIMENDAN IN THE THERAPY OF DIASTOLIC DYSFUNCTION OF CARDIAC SURGERYEUCTR2005-004449-32-ITAZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO A.O. DI RILIEVO NAZIONALE