SEVICONTROL-2:Efficacy and Safety of a sequential therapy change from Candesartan 32 mg to the fixed combination of olmesartan 40 mg/amlodipine 10 mg in patients with poorly controlled moderate hypertension - an open phase IV trial - Sevicontrol-2

IPPMed GmbH0 个研究点开始时间: 2011年9月22日最近更新: 2013年5月6日

适应症

试验速览

暂无简介。

•male or female patients >= 18 years of age
•essential hypertension, i. e. systolic office bp >= 140 mmHg for pre-treated patients or >= 160 mmHg for untreated patients at screening visit and >= 160 mmHg at end of wash-out
•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 80
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•systolic office bp > 180 mm Hg at screening visit
•known hypertensive retinopathy GIII or IV
•recent (< 4 weeks ago) myocardial infarction or indication for coronary or peripheral revascularisation
•type I diabetes or poorly controlled (HbA1c > 8) type II diabetes
•chronic heart failure NYHA III or IV
•prior stroke or TIA
•creatinine clearance < 60 ml/min or condition after kidney transplant
•moderately or severely impaired liver function (ALT or AST or bilirubin more than double normal value)
•women of childbearing potential without effective contraception, pregnant or breastfeeding women
•concomitant therapy with lithium
•hemodynamically relevant mitral or aortic valve stenosis (>= II°) or hypertrophic obstructive cardiomyopathy
•concomitant therapy with strong CYP3A4 inhibitors or inductors
•african patients
•concomitant severe psychiatric condition that might impair proper intake of study medication
•life expectancy < 6 months
•night shift workers
•known other mandatory indication for treatment with antihypertensive medications
•parallel participation in other clinical trials

发起方

IPPMed GmbH