DRKS00003272已完成4 期
Sevicontrol-1: Efficacy and safety of a fixed combination of olmesartan 40 mg / amlodipine 10 mg in patients with insufficiently controlled hypertension under monotherapy with candesartan 32 mg - an open phase IIIb trial - Sevicontrol-1
IPPMed GmbH0 个研究点目标入组 83 人开始时间: 2012年1月4日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •essential hypertension, i. e. systolic OPM >=140 mmHg at screening and >=160 mmHg after two weeks wash-out
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
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