EUCTR2007-001360-76-SK进行中（未招募）1 期
A multi-center, randomized, double-blind, placebo and active controlled, parallel group, dose range study to evaluate the efficacy and safety of LCZ696 comparatively to valsartan, and to evaluate AHU377 to placebo after 8 week treatment in patients with essential hypertension
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,560
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
- •1. Male or female patients from 18 up to including 75 years
- •2. Patients with mild-to-moderate uncomplicated essential hypertension, treatment
- •naïve or currently taking antihypertensive therapy (monotherapy or combination
- •therapy of 2 drugs).
- •3. Treatment naïve patients must have an office mean sitting diastolic blood
- •pressure (MSDBP) = 95 mmHg and < 110 mmHg at the randomization visit (visit
- •3) and the 2 preceding visits (Visits 1 and 2).
- •4. Pretreated patients must have an office MSDBP ³ 90 mmHg and < 110 mmHg
- •after washout (Visit 2), and a MSDBP ³ 95 mmHg and < 110 mmHg at baseline
- •5. Written informed consent to participate in the study prior to any study procedures
- •6. Ability to communicate and comply with all study requirement and demonstrating
- •a good medication compliance (80 % compliance rate) during the run-in period.
- •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
- •For full list, please refer to protocol.
- •1. Severe hypertension (MSSBP =180 mmHg and/or MSDBP =110 mmHg)
- •2. Known or suspected contraindications, including history of allergy to ARBs,
- •NEPi’s or to drugs with a similar chemical structure.
- •3. History of angioedema, drug-related or otherwise as reported by the patient
- •4. History or evidence of a secondary form of hypertension, such as renal
- •parenchymal hypertension, renovascular hypertension, coarctation of the aorta,
- •primary hyperaldosteronism, Cushing’s disease, drug-induced hypertension,
- •unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic
- •kidney disease (PKD), etc.
- •5. Type 1 or Type 2 diabetes mellitus
- •6. History of angina perctoris, myocardial infarction, coronary bypass surgery,
- •ischemic heart disease, surgical or percutaneaous arterial intervention of any
- •kind (coronary, carotid or peripheral intervention), stroke, TIA (transient
- •ischemic attack), carotid artery stenosis or peripheral arterial disease
- •7. Previous or current diagnosis of congestive heart failure NYHA Class II to IV
- •8. Second or third degree heart block without a pacemaker
- •9. Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
- •10. Clinically significant valvular heart disease
研究者
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