NCT02172586已完成4 期
A PROBE (Prospective, Randomised, Open-label, Blinded Endpoint) Trial to Investigate the Efficacy and Safety of Telmisartan 40-80 mg Once Daily Compared With Losartan 50-100 mg Once Daily Over a Period of 12 Weeks, and of Telmisartan 80 mg + HCTZ 12.5 mg Once Daily Compared With Losartan 100 mg Once Daily + HCTZ 12.5 mg Once Daily Over a Period of Further 12 Weeks in Mild to Moderate Hypertensive Patients (Grade 1 and Grade 2 WHO-ISH Guidelines 1999)
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
- 363
- 主要终点
- Change from baseline in diastolic blood pressure (DBP) during the last 6 hours (ABPM - ambulatory blood pressure measurement) of the 24-hour dosing interval at the end of the monotherapy period of treatment
研究概览
简要总结
Study to assess the efficacy of telmisartan 40-80 mg once daily compared with losartan 50-100 mg once daily in hypertensive patients evaluated by change from baseline in diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval, at the end of the 12 weeks period of monotherapy treatment (ABPM - ambulatory blood pressure measurement).
Secondary objectives: Changes from baseline in BP at the end of the monotherapy period of treatment and at the end of the study, evaluated by sphygmomanometric blood pressure measurement and ABPM
Safety:
Incidence of adverse events (AE's); withdrawal due to adverse events; laboratory parameters
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Mild-to-moderate essential hypertension defined as a mean diastolic blood pressure (DBP) ≥ 95 mmHg and < 110 mmHg and systolic blood pressure (SBP) < 180 mmHg measured by manual cuff sphygmomanometer at the end of the wash-out period
- •Written informed consent
排除标准
- •Nursing, pregnancy or childbearing potential women, post-menopausal women will be enrolled with last menstruation > 1 year prior to start wash-out phase or surgically sterile
- •Secondary hypertension
- •Malignant hypertension (retinal haemorrhage, exudates or papillary oedema)
- •Clinically significant sodium depletion as defined by serum sodium level < 130 mEq/L and/or clinically significant hyperkaliemia as defined by serum potassium level > 5.5 mEq/L or clinically significant hypokaliemia as defined by serum potassium level < 3.0 mEq/L
- •Atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which, in the investigator opinion could compromise patient's participation to the trial
- •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, presence of only one functioning kidney
- •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 patients participation to the trial (alcohol or drug abuse, disability illness, etc.)
- •Concomitant therapy with antihypertensive drugs non permitted by protocol, corticosteroids or drugs known to affect blood pressure
- •Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCTZ)
- •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, losartan, HCTZ)
- •Predictable lack of patient co-operation
研究组 & 干预措施
Losartan
Active Comparator
干预措施: Losartan (Drug)
Losartan + Hydrochlorothiazide
Active Comparator
干预措施: Losartan (Drug)
Telmisartan
Experimental
干预措施: Telmisartan (Drug)
Telmisartan + Hydrochlorothiazide
Experimental
干预措施: Telmisartan (Drug)
Telmisartan + Hydrochlorothiazide
Experimental
干预措施: Hydrochlorothiazide (Drug)
Losartan + Hydrochlorothiazide
Active Comparator
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Change from baseline in diastolic blood pressure (DBP) during the last 6 hours (ABPM - ambulatory blood pressure measurement) of the 24-hour dosing interval at the end of the monotherapy period of treatment
时间窗: Baseline and week 12
次要结局
- Change from baseline in DBP during the last 6 hours (ABPM) of the 24-hour dosing interval at the end of the study(Baseline and week 24)
- Change from baseline in systolic blood pressure (SBP) during the last 6 hours (ABPM) of the 24-hour dosing interval(Baseline, week 12 and 24)
- Change from baseline in DBP/SBP during the last 2 hours (ABPM) of the 24-hour dosing interval (trough BP)(Baseline, week 12 and 24)
- Changes from baseline in trough cuff (sphygmomanometer) SBP/DBP(Baseline, week 12 and 24)
- Changes from baseline in SBP/DBP of 24 hours mean ABPM(Baseline, week 12 and 24)
- Comparison of SBP/DBP ABPM tracing profile(Week 12 and 24)
- Smoothness index in comparison with baseline(Baseline, week 12 and 24)
- Number of responders(Week 12 and 24)
- Number of controlled responders(Week 12 and 24)
- Number of patients who withdraw due to lack of efficacy(24 weeks)
- Number of patients with adverse events(24 weeks)
- Number of patients who withdraw due to adverse events(24 weeks)
研究者
相似试验
已完成
4 期
Telmisartan Compared With Enalapril in Elderly Patients With Blood HypertensionHypertensionNCT02177461Boehringer Ingelheim374
已完成
3 期
Efficacy and Safety of Telmisartan and Losartan in Primary HypertensionHypertensionNCT02269176Boehringer Ingelheim330
已完成
4 期
1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt NephropathyDiabetic NephropathiesHypertensionNCT00153023Boehringer Ingelheim885
招募中
4 期
Efficacy and Safety of Telmisartan Compared With LosartanDiabetic NephropathiesHypertensionNCT06431477Chong Kun Dang Pharmaceutical98
已完成
4 期
A Randomized, Double-blind, Placebo Controlled Comparison of Telmisartan Hydrochlorothiazide (HCT) and Valsartan HCT in Hypertension (HTN) Stage I/II PatientsHypertensionNCT00240448Boehringer Ingelheim1,109