EUCTR2004-001150-88-IE进行中（未招募）1 期
Comparison between zofenopril and ramipril in combination with ASA on the extent of cardiovascular risk in patients with systolic left ventricular dysfunction after acute myocardial infarction (SMILE IV trial) - MEN/03/ZOF-CHF/001 Protocol Final version dated: 23 Dec 2003 Amendment No. 1 Final version dated: 01 Jul 2004 - SMILE IV
Menarini International Operation Luxembourg -SA0 个研究点目标入组 0 人开始时间: 2005年3月10日最近更新:
适应症
相关药物
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
入选标准
- •At day 1: a) Written informed consent of the patient; b) Male and female aged 18-85 years; c)Patient suffering from acute myocardial infarction during the 24 hours before inclusion in the study and treated or not with thrombolytic drugs in the previous 12 hours.
- •At day 5: Acute myocardial infarction with clinical (Killip class > 1, NYHA class > I, combination of 31 heart sound + pulmonary rales + pulmonary congestion on chest X-ray) or echocardiographic (LVEF < 45%) evidence of systolic LV dysfunction.
- •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
- •At day 1: a) Ipersensibility to ACEI or ASA; b) Systemic hypotension (SBP < 90 mmHg); c) Renal failure with serum creatinine > 2.5 mg/dL (221 µmol/L); d) Angioneurotic oedema; e) Severe liver failure (AST and/or ALT 3 times the upper normal limit); f) Bilateral stenosis of renal artery or unilateral stenosis in patients with one kidney; g) Mitral or aortic stenosis; h) Thrombocytopenia, leucopenia, agranulocytosis; i) Hemorrhagic diseases, disease that may give bleeding (i.e gastric ulcer); j) Acute stroke; k) LES and/or systemic sclerodermia; l) Concomitant chronic anticoagulant treatment; m) Patients undergoing primary PTCA with combined antiplatelet therapy including Clopidogrel + ASA; n) Any other reason according with Investigator's judgement that controindicate the participation of the patient to the study; o) Pregnancy, breastfeeding and women with childbearing potential not using effective contraception.
- •At day 5: a) Ipersensibility to ACEI, or ASA; b) Systemic hypotension (SBP < 90 mmHg); c) Renal failure with serum creatinine > 2.5 mg/dL (221 µmol/L); d) Angioneurotic oedema; e) Severe liver failure (AST and/or ALT 3 times the upper normal limit); f) Bilateral stenosis of renal artery or unilateral stenosis in patients with only one kidney; g) Mitral or aortic stenosis; h) Thrombocytopenia, leucopenia, agranulocytosis; i) Hemorrhagic diseases, disease that may give bleeding (i.e. gastric ulcer); j) Acute stroke; k) LES and/or systemic sclerodermia; l) Concomitant chronic anticoagulant treatment; m) Patients undergoing primary PTCA with combined antiplatelet therapy including Clopidogrel + ASA; n) Patients in which a PTCA is planned in the next months due to cardiac conditions; o) Any other reason according with Investigator's judgement that controindicate the participation of the patient to the study; p) Pregnancy, breastfeeding and women with childbearing potential not using effective contraception.
研究者
相似试验
进行中（未招募）
不适用
Comparison between zofenopril and ramipril in combination with ASA on the extent of cardiovascular risk in patients with systolic left ventricular dysfunction after acute myocardial infarction (SMILE IV trial) - MEN/03/ZOF-CHF/001Protocol Final version dated: 23 Dec 2003Amendment No. 1 Final version dated: 01 Jul 2004Amendment No. 2 Final version dated: 26 Apr 2005 - SMILE IVSystolic left ventricular dysfunction after AMIMedDRA version: 7.0Level: LLTClassification code 10049694EUCTR2004-001150-88-ESMenarini International Operation Luxembourg -SA896
已完成
1 期
Bioequivalence of Zofenopril and Nebivolol following their oral co-administration as fixed or extemporaneous combination in healthy volunteers. An open label, randomized, two periods, two sequences, cross-over studybioequivalence study in healthy subjectsDRKS00020911Menarini Ricerche S.p.A.37
招募中
不适用
With ondansetron, comparison of propofol and remimazolam besilate for the prevention of postoperative nausea and vomiting.JPRN-UMIN000046237Department of Anesthesiology,Tokushima University Hospital60
尚未招募
Unknown
Comparison of remimazolam-flumazenil and propofol on emergence profile and cough in nasal surgeryDiseases of the respiratory systemKCT0009152Ajou University Hospital64
尚未招募
Unknown
Comparison of effects of remimazolam and propofol on mask ventilation during general anesthesia induction: a randomized controlled trialMask ventilation during general anesthesia inductionJPRN-UMIN000053553Seoul National University Bundang Hospital76