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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 12
- 主要终点
- Change in ABPM (ambulatory blood pressure measurement) mean daytime systolic values and change in systolic OBPM (office blood pressure measurement).
研究概览
简要总结
The investigators want to find out whether a recently introduced combination of two blood pressure lowering agents (olmesartan and amlodipine) has a different blood pressure lowering effect than a single active substance. In addition the investigators want to find out whether there is a difference in the changes in blood pressure over the course of a day depending on the time when the medications are taken (in the morning or at night). Male and female patients over 18 years of age may participate.
详细描述
Investigation of changes in blood pressure after six weeks therapy with a fixed combination of 40 mg olmesartan and 10 mg amlodipine compared to a monotherapy with 32 mg candesartan. Investigation of changes in dipping-profile after a further six weeks of therapy with the fixed combination when time of intake is switched from morning to evening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
研究组 & 干预措施
Olmesartan/Amlodipin fixed combination
干预措施: Candesartan cilexetil (Drug)
Olmesartan/Amlodipin fixed combination
干预措施: Olmesartan/Amlodipin (Drug)
结局指标
主要结局
Change in ABPM (ambulatory blood pressure measurement) mean daytime systolic values and change in systolic OBPM (office blood pressure measurement).
时间窗: after six and after 12 weeks
After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan
change in systolic OBPM
时间窗: after 6 and after 12 weeks
After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan: change in systolic OPM.
次要结局
- Distribution of patients over the four dipper types(after six and after 12 weeks)
- Number of patients achieving target values for OBPM and ABPM(after six and after 12 weeks)
- change in 24 hr mean values and diastolic day mean value(after six and after 12 weeks)
- Change in systolic and diastolic ABPM night mean values(after 6 weeks therapy with fixed combination of olmesartan and amlodipine)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(From screening visit to end of follow-up, up to 20 weeks)
- change in diastolic OBPM(after six and after 12 weeks)