NCT02206659已完成3 期
An Open-label Evaluation of Trough and Peak Effects of 40 mg Telmisartan Tablet by Ambulatory Blood Pressure Monitoring in Chinese Patients With Mild to Moderate Essential Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Mean of trough/peak (T/P) ratio for diastolic blood pressure (DBP) and systolic blood pressure (SBP)
研究概览
简要总结
To assess the trough/peak ratio of 40 mg Telmisartan tablet by ambulatory blood pressure monitoring in Chinese patients with mild to moderate essential hypertension
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese male or female aged 18 to 75 years
- •Mild to moderate hypertension defined as a morning DBP _95 and <110 mm Hg at visit1 and visit
- •Mean sitting systolic pressure (SBP) must be <180 mm Hg
- •Ability to provide written informed consent
排除标准
- •Women who are pregnant or breast-feeding, or of childbearing potential without an effective method of birth control (effective birth control methods are: uterine device, surgical sterilisation, progestogens alone)
- •Known or suspected secondary hypertension
- •Known history of any chronic hepatic disease
- •Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant
- •New York Heart Association (NYHA) functional class congestive heart failure (CHF) III-IV
- •Unstable angina pectoris
- •Myocardial infarction or percutaneous transluminal coronary angiography (PTCA) or cardiac surgery within the preceding three months
- •Clinical relevant cardiac arrhythmias as determined by the clinical investigator
- •Hypertrophic obstructive cardiomyopathy or clinically significant valvular disease
- •Evidence of retinal hemorrhages/exudates
- •Clinical significant hyperkalemia as defined by serum potassium level >6.0 milliequivalents (mEq)/L
- •Insulin-dependent diabetes mellitus
- •Non-insulin-dependent diabetes mellitus with poor glucose control as defined by persistent fasting blood sugar >200 mg/dl, peripheral neuropathy or autonomic neuropathy
- •Known drug or alcohol dependency
- •Administration of any diuretic, ACE inhibitor or angiotensin II receptor antagonist within two weeks before run-in period
- •Administration of medication known to affect blood pressure during trial period
- •Patients receiving any investigational therapy within one month of signing the informed consent form
- •Known hypersensitivity to any component of the formulation
- •Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of trial medication
研究组 & 干预措施
Telmisartan
Experimental
2-week placebo run-in period followed by 6 weeks of treatment with telmisartan
干预措施: Telmisartan (Drug)
Telmisartan
Experimental
2-week placebo run-in period followed by 6 weeks of treatment with telmisartan
干预措施: Placebo (Drug)
结局指标
主要结局
Mean of trough/peak (T/P) ratio for diastolic blood pressure (DBP) and systolic blood pressure (SBP)
时间窗: 42 days after start of treatment
Median of T/P ratio for DBP and SBP
时间窗: 42 days after start of treatment
次要结局
- Change in mean 24-hr DBP and SBP(Day -13, 42 days after start of treatment)
- Change in nighttime mean for SBP and DBP(Day -13, 42 days after start of treatment)
- Change in daytime mean for SBP and DBP(Day -13, 42 days after start of treatment)
- Change in mean of DBP and SBP for last 6-hr dosing interval(Day -13, 42 days after start of treatment)
研究者
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