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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 11
- 主要终点
- Change in systolic daytime mean ABPM (long-term ambulatory blood pressure monitoring) values
研究概览
简要总结
The investigators want to find out if a treatment with a new combination of two different antihypertensive drugs (olmesartan and amlodipine) in one tablet in patients with moderately elevated blood pressure is more effective than treatment with just one substance (candesartan). All antihypertensive treatment will be ceased for two weeks to achieve comparable baseline conditions. Treatment is then started with the single substance. After six weeks, therapy is changed to another single substance and after a further six weeks, to the fixed combination tablet. Blood pressure is determined by office measurements taken by the doctor and via long-term ambulatory blood pressure monitoring (ABPM). Participants may be male or female and must be over 18 years of age.
详细描述
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
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
- •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
- •signed IC
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
- •parallel participation in other clinical trials
研究组 & 干预措施
Single Arm
Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days, then olmesartan 40 mg tablets once daily for 42 days, then olmesartan/amlodipine 40/5 mg tablets once daily for 14 days, then olmesartan/amlodipine 40/10 mg tablets once daily for 28 days
干预措施: Candesartan cilexetil (Drug)
Single Arm
Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days, then olmesartan 40 mg tablets once daily for 42 days, then olmesartan/amlodipine 40/5 mg tablets once daily for 14 days, then olmesartan/amlodipine 40/10 mg tablets once daily for 28 days
干预措施: Olmesartan medoxomil (Drug)
Single Arm
Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days, then olmesartan 40 mg tablets once daily for 42 days, then olmesartan/amlodipine 40/5 mg tablets once daily for 14 days, then olmesartan/amlodipine 40/10 mg tablets once daily for 28 days
干预措施: Olmesartan/amlodipine (Drug)
结局指标
主要结局
Change in systolic daytime mean ABPM (long-term ambulatory blood pressure monitoring) values
时间窗: ABPM will be performed after 6 weeks treatment with each of the different therapy regimes.
After six weeks therapy with a monotherapy with olmesartan 40 mg and further six weeks treatment with a fixed combination of olmesartan 40 mg and amlodipine 10 mg compared to previous monotherapy with candesartan.
次要结局
- Change in systolic/diastolic office blood pressure and mean values (night-time and 24 hr for systolic bp and day-time, night-time and 24 hr for diastolic bp)(after 6 and 12 weeks)