EUCTR2014-003470-17-RO进行中（未招募）1 期
The efficacy and safety of olmesartan medoxomil/amlodipine fixed combination in patients with grade 1 to grade 2 arterial hypertension. An international randomized, double-blind, 10-week multi-factorial clinical study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 997
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
- •Mean SeDBP of 90 to 109 mm Hg at the screening ( Visit 1/screening) and the baseline (Visit 2)
- •Men and women, aged 18-75 years
- •Written informed consent
- •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 560
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •History of hypersensitivity to any components of the medicines used in the trial or history of intolerance to amlodipine and/or olmesartan medoxomil
- •Known secondary arterial hypertension (e.g. pheochromocytoma, primary aldosteronism, renal artery stenosis)
- •History of left ventricular hypertrophy or obstruction of the left ventricular outflow tract (e.g. hemodynamically significant aortic stenosis)
- •Ischaemic heart disease or ischaemic cerebrovascular disease
- •Heart failure on medication therapy
- •Chronic disease other than arterial hypertension requiring chronic use of beta-blockers or calcium antagonists (e.g. tachyarrhythmia, glaucoma)
- •Clinically and laboratory evident biliary obstruction with both jaundice and increased total serum bilirubin over 50 micromol / l
- •Renal impairment (creatinine clearance < 60 mL/min)
- •Previous or current therapy with olmesartan medoxomil and amlodipine taken concomitantly
- •Current therapy with:
- •Other antihypertensive drugs, if introduced/modified less than 6 weeks prior to enrolment
- •Any not allowed” medication(s) listed in section 6.2.
- •Any acute disease (severe infection, exacerbation or uncontrolled phase of a chronic disease, major trauma, surgery) within 30 days prior to screening visit
- •Following clinically relevant laboratory or ECG findings:
- •i.e. significant anaemia with hemoglobin less than 80 g/l,
- •significant thrombocytopenia with platelet count less than 50.000/microliter
- •serum AST and/or ALT and/or ALP of more than 3 x ULN (upper limit of normal)
- •hyperkalaemia (serum potassium of more than 5 mmol/l)
- •A-V block grade 2 or 3
- •ECG signs of acute ischemia
- •Symptomatic bradycardia with heart rate less than 50/min
- •Smoking more than 20 cigarettes/day
- •Pathological clinical states that could affect subject’s compliance, or have any impact on subject’s short-term survival rate (malignant diseases, excessive alcohol consumption, drug abuse or drug addiction, psychiatric conditions)
- •Pregnancy and lactation
- •Women with no reliable contraception
- •Subjects currently participating in another clinical trial
- •Subject’s refusal to participate with the investigator
研究者
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