A Multicenter Open-label Study of the Efficacy and Safety of Telmisartan in Mild to Moderate Hypertensive Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 134
- 主要终点
- Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
研究概览
简要总结
To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with ABPM
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients with blood pressure levels of 140/90 mm Hg or higher (confirmed on 2 consecutive visits), who were 18 years old and older, regardless of sex
排除标准
- •Suspected or known diagnosis of arterial hypertension with a secondary cause
- •Women who were not using an effective method of contraception, or who were pregnant, or breast-feeding
- •Systolic blood pressure > 200 mm Hg or diastolic blood pressure > 115 mm Hg
- •Laboratory test values two fold above the upper normal limit
- •Previous intolerance to angiotensin conversion enzyme inhibitors or angiotensin II blocker (AIIAR)
- •New York Heart Association class III or IV heart failure
- •History of stroke in the 6 months prior to entry into the study
- •Uncontrolled type 2 diabetes mellitus, defined as fasting glucose levels > 140 mg/dL on 3 consecutive assessments
- •Patients who were included in another investigational drug study in the past 30 days
研究组 & 干预措施
Low dose of telmisartan
4 week placebo run-in phase followed by 6 weeks of treatment with low dose of telmisartan
干预措施: Low dose of telmisartan (Drug)
Low dose of telmisartan
4 week placebo run-in phase followed by 6 weeks of treatment with low dose of telmisartan
干预措施: Placebo (Drug)
High dose of telmisartan
After 6 weeks of treatment with low dose of telmisartan, titration to high dose of telmisartan if blood pressure level is higher than 140/90 mm Hg
干预措施: High dose of telmisartan (Drug)
结局指标
主要结局
Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
时间窗: Baseline, up to 12 weeks after start of treatment
Blood pressure values were obtained 24 hours after the last dose (through values) at the office
次要结局
- Assessment of treatment response for SBP/DBP (in %)(Baseline, up to 12 weeks after start of treatment)
- Changes from baseline in blood pressure values(Baseline, up to 12 weeks after start of treatment)
- Number of patients with adverse events(Up to 16 weeks)
- Number of patients with clinically significant changes in laboratory values(Up to 16 weeks)
- Number of patients with clinically significant changes in ECG(Up to 16 weeks)