NCT02177461已完成4 期
A PROBE (Prospective, Randomised, Open-Label, Blinded Endpoint) Trial to Investigate the Efficacy and Safety of Telmisartan 40-80mg Once Daily Compared With 10-20 mg Enalapril Once Daily Over a Period of 24 Weeks in Elderly Patients With Blood Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 374
- 主要终点
- Change from baseline in 24-hours mean systolic blood pressure (SBP) (ABPM - ambulatory blood pressure measurement, 24 hours mean represents the average of 24 hourly mean values)
研究概览
简要总结
Study to assess the efficacy and tolerability of Telmisartan 40-80 mg once daily compared with enalapril 10-20 mg once daily in elderly patients with arterial hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years
- •Sitting systolic blood pressure (SBP) ≥ 160 mmHg and any diastolic blood pressure (DBP) (safety maximum of sitting DBP 110 mmHg), measured by manual cuff sphygmomanometer at the end of the wash-out period
- •Written informed consent
排除标准
- •Secondary hypertension
- •Malignant hypertension (retinal haemorrhage, exudates or papillary oedema)
- •Clinically significant sodium depletion as defined by serum sodium level < 130 mEq/L, clinically significant hyperkaliemia as defined by serum potassium level > 5.5 mEq/L, clinically significant hypokaliemia as defined by serum potassium level < 3.0 mEq/L
- •Atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which could interfere with the cardiac rhythm
- •Heart rate < 50 bpm
- •Congestive heart failure (CHF) (NYHA (New York Heart Association) functional class CHF III-IV)
- •Angina pectoris or myocardial infarction
- •Cardiac surgery within the past 3 months prior to start the wash-out period
- •Stroke within the past 6 months prior to start the wash-out period
- •Renal insufficiency defined as creatininaemia > 2mg/dl
- •Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post renal transplant
- •Liver insufficiency, defined as bilirubinaemia > 2mg/dl and AST (aspartate aminotransferase) or ALT (alanine-aminotransferase) > twice the upper normal range
- •Clinically significant metabolic and endocrine disease
- •Autoimmune disease
- •Previous history of angioedema
- •Body mass index > 30kg/m2
- •Arm circumference > 32 cm
- •Any condition that may be likely to compromise the trial (alcohol or drug abuse, disability illness, etc.)
- •Concomitant therapy with antihypertensive drugs non-permitted by protocol, or present use of tricyclic antidepressant, corticosteroids or drugs known to affect blood pressure
- •Investigational drug treatment within the past 30 days before the enrolment or concurrent participation to any other trial
- •Sensitivity, significant adverse reaction or contraindications to the study drugs (telmisartan, enalapril, clonidine TTS)
- •Predictable lack of patient co-operation
研究组 & 干预措施
Enalapril + clonidine TTS1
Active Comparator
干预措施: Enalapril (Drug)
Telmisartan
Experimental
干预措施: Telmisartan (Drug)
Enalapril
Active Comparator
干预措施: Enalapril (Drug)
Telmisartan + clonidine TTS1
Experimental
干预措施: Telmisartan (Drug)
Telmisartan + clonidine TTS1
Experimental
干预措施: Clonidine (Drug)
Enalapril + clonidine TTS1
Active Comparator
干预措施: Clonidine (Drug)
结局指标
主要结局
Change from baseline in 24-hours mean systolic blood pressure (SBP) (ABPM - ambulatory blood pressure measurement, 24 hours mean represents the average of 24 hourly mean values)
时间窗: Baseline and week 8
次要结局
- Number of responders(Week 8 and 24)
- Number of controlled responders(Week 8 and 24)
- Changes from baseline in trough cuff (sphygmomanometer) SBP(Baseline, week 8 and 24)
- Comparison of SBP ABPM tracing profile(Week 8 and 24)
- Smoothness index in comparison with baseline(Baseline, week 8 and 24)
- Incidence of adverse events(24 weeks)
- Number of patients who withdraw due to adverse events(24 weeks)
研究者
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