NCT00679484终止3 期
A 24-Week Multicentre, Randomized, 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)
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company0 个研究点目标入组 400 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 400
- 主要终点
- Absolute BNP change from week 0 to 24 of treatment
研究概览
简要总结
This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a prognostic biomarker of heart failure, at week 24
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 randomization 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
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 If a female becomes pregnant during the study, she has to be withdrawn immediately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, revascularization or resynchronization 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)
研究组 & 干预措施
1
Experimental
干预措施: olmesartan medoxomil + candesartan cilexetil placebo (Drug)
2
Experimental
干预措施: olmesartan medoxomil placebo + candesartan cilexetil (Drug)
结局指标
主要结局
Absolute BNP change from week 0 to 24 of treatment
时间窗: 24 weeks
次要结局
- Change in clinical status: Improvement: patient alive without any cardiovascular event with an improvement of at least one NYHA functional class level; No change: patient alive without any cardiovascular event with stable functional NYHA class(24 weeks)
- Proportion of BNP responders at week 4, 8, 16 and 24 (BNP levels reduced to 350 pg/ml or less at all time points)(24 weeks maximum)
- BNP change from week 0 to week 4, 8, and 16(16 weeks maximum)
- Incidence of critical events at 24 weeks: All cause death; Cardiovascular death defined as death due to: HF, myocardial infarction, cardiac arrhythmia, stroke/cerebral vascular accident, other cardiovascular cause (e.g., aneurysm or pulmonary embolism)(24 weeks)
- Event-free survival(24 weeks)
- Time-to-first cardiovascular event(24 weeks maximum)
- Time-to-death(24 weeks)
研究者
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