Safety and efficacy of fixed dose combination of Indapamide SR 1.5 mg / Amlodipine versus Valsartan / Amlodipine over 12-week of treatment with conditional titration based on the blood pressure control, in patients with uncontrolled essential hypertension after 1 month of Amlodipine 5 mg run-in treatment. An international, randomized, double-blind, multicenter controlled study.

Institut de Recherches Internationales Servier0 个研究点目标入组 448 人开始时间: 2013年7月3日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•- Men or women of any ethnic origin,
•- Age = 18 years old or legal national majority,
•- Confirmed essential uncontrolled hypertension,
•- Normal or without any clinically significant anomaly 12-lead ECG (LVH authorized).
•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 363
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 85

•-Patients treated for hypertension with more than one antihypertensive monotherapy at selection.
•-History of hypertension known to be resistant to the free or fixed bi-therapy combination with sartans, diuretics and calcium channel inhibitors or contra-indications to treatment with them.
•-Patient with history of intolerance with one or several of the study drugs, either valsartan, amlodipine or indapamide.
•-Apparent or suspected secondary hypertension (known renal parenchymal hypertension, renovascular hypertension, pheochromocytoma, Cushing’s syndrome, coarctation of the aorta, drug-induced hypertension, liquorice-induced hypertension and especially primary hyperaldosteronism).
•-Known complicated hypertension: known stage III or IV hypertensive retinopathy, macroalbuminuria.
•-Lymphedema or leg edema (bilateral).
•-Orthostatic hypotension at inclusion.
•-Positive pregnancy test or results not available.

发起方