EUCTR2009-011558-16-DE进行中（未招募）不适用
Evaluation of the effects of 4 oral dosages of S 44121 versus placebo on cardiac function and NT-proBNP in patients with chronic heart failure and left ventricular dysfunction. A 12-week, randomized, double-blind, parallel-group, placebo controlled, international multicentre study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
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 or female patients superior or equal to 18 years and less or equal to 75 years.
- •- Symptomatic chronic heart failure for at least 6 months before selection.
- •- NYHA functional class II or III.
- •- Ischemic disease or idiopathic dilated cardiomyopathy as main cause for CHF.
- •- Left ventricular systolic dysfunction as evidenced by a LVEF less or equal to 35 % as measured within 6 months before selection.
- •- Beta-blocker treatment for at least 3 months before selection.
- •- ACE inhibitor and/or an ARB treatment for at least 3 months before selection.
- •- NT-proBNP plasma concentration superior or equal to 400 pg/mL or BNP plasma concentration superior or equal to 100 pg/mL.
- •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
- •- Unstable condition within the previous 4 weeks before selection.
- •- Recent (less than 3 months before selection) myocardial infarction, unstable angina or coronary revascularisation.
- •- History of stroke or cerebral transient ischemic attack within the previous 3 months before selection.
- •- Severe aortic or mitral stenosis, severe aortic regurgitation, or severe mitral regurgitation.
- •- Congenital heart disease.
- •- Hypertrophic obstructive cardiomyopathy.
- •- Pericardial disease.
- •- Atrio-ventricular block of second or third degree.
- •- Corrected QT interval duration (Bazett’s formula) > 450 ms.
- •- Family history of long QT syndrome or congenital long QT syndrome.
- •- Serum creatinine > 200 micromoles/L (> 2.26 mg/dL).
- •- ALAT or ASAT > 3 times the upper limit of normal values.
- •- Serum total calcium < 2.1 mmol/L or > 2.6 mmol/L.
- •- Blood hemoglobin lower than 110 g/L (in males) or lower than 100 g/L (in females).
研究者
相似试验
进行中（未招募）
1 期
Evaluation of the effects of 4 oral dosages of S 44121 versus placebo on cardiac function and NT-proBNP in patients with chronic heart failure and left ventricular dysfunction not treated with a beta-blocker. A 12-week, randomized, double-blind, parallel-group, placebo controlled, international multicentre study - S44121 vs placebo in chronic heart failure patients not on betablockerChronic heart failure and left ventricular dysfunctionMedDRA version: 14.1 Level: PT Classification code 10049694 Term: Left ventricular dysfunction System Organ Class: 10007541 - Cardiac disordersMedDRA version: 14.1 Level: PT Classification code 10007558 Term: Cardiac failure chronic System Organ Class: 10007541 - Cardiac disordersEUCTR2009-011559-38-GBInstitut de Recherches Internationales Servier125
进行中（未招募）
不适用
Evaluation of the effects of 4 oral dosages of S 44121 in patients with chronic heart failure and left ventricular dysfunction not treated with a beta-blocker.Chronic heart failure and left ventricular dysfunctionMedDRA version: 14.1Level: PTClassification code 10007558Term: Cardiac failure chronicSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 14.1Level: PTClassification code 10049694Term: Left ventricular dysfunctionSystem Organ Class: 10007541 - Cardiac disordersEUCTR2009-011559-38-DEInstitut de Recherches Internationales Servier125
进行中（未招募）
不适用
Evaluation of the effects of 4 oral dosages of S 44121 in patients with chronic heart failure and left ventricular dysfunction not treated with a beta-blocker.Chronic heart failure and left ventricular dysfunctionMedDRA version: 14.0Level: PTClassification code 10049694Term: Left ventricular dysfunctionSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 14.0Level: PTClassification code 10007558Term: Cardiac failure chronicSystem Organ Class: 10007541 - Cardiac disordersEUCTR2009-011559-38-LVInstitut de Recherches Internationales Servier125
进行中（未招募）
不适用
Evaluation of the effects of 4 oral dosages of S 44121 in patients with chronic heart failure and left ventricular dysfunction not treated with a beta-blocker.Chronic heart failure and left ventricular dysfunctionMedDRA version: 14.1Level: PTClassification code 10007558Term: Cardiac failure chronicSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 14.1Level: PTClassification code 10049694Term: Left ventricular dysfunctionSystem Organ Class: 10007541 - Cardiac disordersEUCTR2009-011559-38-EEInstitut de Recherches Internationales Servier125
进行中（未招募）
不适用
Evaluation of the effects of 4 oral dosages of S 44121 versus placebo on cardiac function and NT-proBNP in patients with chronic heart failure and left ventricular dysfunction not treated with a beta-blocker. A 12-week, randomized, double-blind, parallel-group, placebo controlled, multicentre study. - NDChronic heart failure and left ventricular dysfunctionMedDRA version: 9.1Level: LLTClassification code 10007558MedDRA version: 9.1Level: LLTClassification code 10049694EUCTR2009-011559-38-ITINSTITUT DE RECHERCHES INTERNATIONALES SERVIER125