A randomized, double-blind, active-controlled, parallel group, 52-week study to evaluate the effect of LCZ696 compared to olmesartan on regional aortic stiffness in subjects with essential hypertension.

ovartis Pharma Services AG0 个研究点目标入组 110 人开始时间: 2013年6月24日最近更新: 2016年6月27日

适应症

试验速览

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•Subjects with essential hypertension, untreated or currently taking antihypertensive therapy:
•Untreated subjects must have mean seated (ms) SBP= 140 mmHg and < 180 mmHg at screening and baseline.
•Treated subjects must have a msSBP < 180 mmHg at screening and a mean seated SBP = 140 mmHg and < 180 mmHg at baseline after washout of antihypertensive drugs.
•Pulse rate between 45 and 100 bpm, inclusive at screening and baseline.
•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 110
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•WOCBP if not on highly effective contraception
•Malignant or severe hypertension (grade 3 of WHO classification; msDBP =110 mmHg and/or msSBP =180 mmHg) at screening or at baseline.
•History of angioedema, drug-related or otherwise.
•History or evidence of a secondary form of hypertension
•Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
•History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to screening.
•History of peripheral artery disease requiring surgical or percutaneous interventions during the 12 months prior to screening.
•Type 1 diabetes mellitus.
•Type 2 diabetes mellitus not well controlled with oral anti-diabetic medication or treated with insulin.
•Previous or current diagnosis of heart failure (New York Heart Association Class II-IV).
•Clinically significant valvular heart disease at screening.

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