EUCTR2004-002077-23-IE进行中（未招募）不适用
Efficacy and safety of Olmesartan medoxomil in elderly patients with mild to moderate hypertension
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 390
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
- •Patients of both sexes responding to the following criteria will be enrolled:
- •–age >65 and <89 years;
- •–new diagnosis of Grade 1 or 2 essential arterial hypertension (systolic arterial pressure when seated 140-179 mmHg and diastolic arterial pressure when seated 90-109 mmHg);
- •essential arterial hypertension Grade 1 or 2 not controlled with current treatment or with intolerance to current treatment;
- •–absence of contraindications with use of Olmesartan medoxomil and Ramipril;
- •–letter of informative notes for patient and signature of informed consent;
- •–patient residence stable and compatible with the study’s needs;
- •–willingness to respect the medical controls planned in the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •–Grade 3 essential arterial hypertension (systolic arterial pressure when seated ³ 180 mmHg and/or diastolic arterial pressure when seated ³ 110 mmHg);
- •–secondary or malign arterial hypertension;
- •–unstable angina;
- •–Atrial fibrillation;
- •–Frequent ventricular ectopic beats or other arrhytmias which could interfere with blood pressure recording ;
- •–cardiac arrhythmia requiring administration of anti-arrhythmic medicines;
- •–heart failure requiring medical treatment;
- •–myocardial infarction in the previous 6 months;
- •–cerebrovascular events in the previous 6 months;
- •–haemodynamically significant valvulopathy;
- •–hereditary/idiopathic angioedema;
- •–history of angioedema associated with previous ACE-inhibitor therapy;
- •–bilateral renal arterial stenosis, or unilateral for patients with a single kidney;
- •–severe concurrent pathology (tumour, AIDS, chronic hepatosis, etc.);
- •–dementia, psychosis, alcoholism or chronic abuse of medicines, drugs or psychoactive substances;
- •–chronic use of concomitant therapies among those not permitted (that might influence blood pressure values as mentioned in chapter 5.8) and which can not be suspended without harm to the patient;
- •–hypersensitivity or contraindications to use of the product under study;
- •–history of side effects with ACE-inhibitors or AT1-antagonists;
- •–pregnancy or breast-feeding;
- •–participation in other clinical trials in the previous 4 months;
- •–conditions which in the Investigator’s opinion may interfere with the study’s execution or due to which the patient should not participate for safety reasons;
- •–risk of low patient cooperation
- •–hepatic pathology (transaminasaemia >3 times greater than normal upper limit);
- •–renal insufficiency (creatininaemia >200 µmol/l or 2 mg/dl);
- •–hypokalemia (<3,5 mEq/l) or hyperkalemia (>5,0 mEq/l)
研究者
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