EUCTR2011-004235-31-DE进行中（未招募）不适用
SEVICONTROL-1:Efficacy and safety of a fixed combination of olmesartan 40 mg/amlodipin 10 mg in patients with moderate essential hypertension not sufficiently controlled under monotherapy with candesartan 32 mg - an open phase IIIb trial - SEVICONTROL-1
IPPMed GmbH0 个研究点开始时间: 2011年9月22日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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 highly 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
研究者
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