EUCTR2007-003060-22-FR进行中（未招募）1 期
A 24-WEEK MULTICENTRE, RANDOMISED, DOUBLE BLIND, CONTROLLED, PARALLEL GROUP NON-INFERIORITY STUDY TO ASSESS THE EFFICACY AND SAFETY OF OLMESARTAN MEDOXOMIL VERSUS CANDESARTAN CILEXETIL IN PATIENTS WITH SYMPTOMATIC HEART FAILURE (NYHA II-IV) - OLMEBNP
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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, adult, out-patients aged between 18 and 85 years.
- •Patients with documented hospital admission within the previous 3 months before randomisation with discharge diagnosis of CHF.
- •Patients with functional NYHA class II-IV with LVEF < 40% assessed within the last 3 months,
- •Patients with blood BNP levels > 400 pg/ml or NT-ProBNP levels > 1500 pg/ml.
- •Patients with CHF due to ischemic heart disease, idiopathic dilated cardiomyopathy (IDC), mitral or aortic insufficiency or hypertension.
- •Patients with stable conventional treatment with diuretics, ACEI and/or beta-blockers and/or aldosterone antagonists for at least 2 months prior to randomisation, unless documented contraindication or intolerance.
- •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
- •Females who are pregnant or plan a pregnancy during the time of the trial, are nursing or are of childbearing potential and not using acceptable methods of contraception. If a female becomes pregnant during the study, she has to be withdrawn immediately.
- •Patients with current hospitalisation due to heart failure.
- •Patients with stroke or transient ischemic attack (TIA) within the last 3 months.
- •Patients with acute coronary syndrome, myocardial infarction, coronary artery bypass or angioplasty within 3 months.
- •Planned cardiac surgery, revascularisation or resynchronisation within the study period.
- •Patients with operable valvular disease or significant obstructive cardiomyopathy.
- •Patients with bradycardia [heart rate (HR) < 50 bpm].
- •Patients with hypotension [systolic blood pressure (SBP) < 90 mmHg].
- •Patients with obstructive pneumopathy.
- •Patients with clinical significant renal failure (creatininemia > 200 micromol/l).
- •Patients with clinically significant laboratory abnormalities including:
- •- Aspartate aminotransferase (ASAT), Alanine aminotransferase (ALAT) or alkaline phosphatase (ALP) greater than 3 times the upper limit of the laboratory reference range,
- •- Bilirubin greater than twice the upper limit of the laboratory reference range,
- •- Haemoglobin < 9 g/dl or < 90 g/l or 5.586 mmol/l.
- •Patients who used ARB (including olmesartan medoxomil and candesartan cilexetil) for more than 7 consecutive days within the last 3 months.
- •Patients with a beta-blocker therapy initiated less than 3 months before randomisation
- •Patients with history of intolerance/ hypersensitivity to ARB, or to drugs with similar chemicals.
- •Patients with autoimmune diseases, collagenosis, insulin-dependent or poorly controlled diabetes.
研究者
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