A Multi-center, Randomized, Double-blind, Active-controlled, 8-week Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients with Essential Hypertension

ovartis Pharma K.K.0 个研究点目标入组 1,629 人开始时间: 2012年6月28日最近更新: 2023年10月17日

研究概览

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•Patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy.
•-Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1) must have an msSBP >= 150 mmHg and < 180 mmHg at the randomization visit (Visit 201) and msSBP >= 140 mmHg < 180 mmHg at the visit immediately proceeding Visit 201 (Visit 102 or 103).
•-Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP >= 150 mmHg and < 180 mmHg at both Visit 1 and Visit 201.
•-Patients must have an absolute difference of =< 15 mmHg in msSBP between Visit 201 and the immediately preceding visit.

•-Severe hypertension (msDBP >= 110 mmHg and/or msSBP >= 180 mmHg).
•-History of angioedema, drug-related or otherwise, as reported by the patient.
•-History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
•-Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.
•Other protocol-defined inclusion/exclusion criteria may apply.

发起方

ovartis Pharma K.K.