NL-OMON31167已完成2 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 - LCZ696, AHU377 and valsartan in patients with essential hypertension
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •For complete list, please refer to the protocol pg 17;- Male or female patients from 18 up to and including 75 years
- •- Patients with mild-to-moderate uncomplicated essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy of 2 drugs)
- •-Untreated patients must have an office MSDBP higher than or equal to 95 mmHg at the randomization visit (V3) and the 2 preceding visits (V1 and V2)
- •-Pretreated patients must have an office MSDBP higher than or equal to 90 mmHg after washout (V2), and a MSDBP higher than or equal to 95 mmHg at baseline (V3)
排除标准
- •For complete list, please refer to protocol pg 17/18;-Severe hypertension (MSSBP equal to or higher than 180 mmHg and/or MSDBP equal to or higher than 110 mmHG)
- •- Known or suspected contraindications, including history of allergy to ARBs, NEPis or to drugs with a similar chemical structure
- •- History of angiodema, drug-related or otherwise, as reported by the patient
- •-Type 1 or Type 2 diabetes mellitus (according to the ADA criteria)
- •- 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.
- •- History of angina pectoris, myocardial infarction, coronary bypass surgery, ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral intervention), stroke, TIA, carotid artery stenosis, aortic aneurysm or peripheral arterial disease
- •- Women of child-bearing potential, unless they are post-menopausal or use predefined acceptable methods of contraception
研究者
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