An Open-Label, Long-term (52-week), Safety Trial of the Fixed Dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 12.5mg and Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg in Patients With Essential Hypertension - Efficacy and Safety Evaluation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 4
- 主要终点
- Changes in clinical laboratory tests (haematology, blood chemistry and urinalysis)
研究概览
简要总结
The objective of this trial is to assess the safety and efficacy of 52 weeks of open-label treatment with the fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg and telmisartan 40 mg plus HCTZ 12.5 mg in patients with essential hypertension.
详细描述
This is a multi-centre study with three centres participating with a target of 30 to 90 patients entering the maintenance period and 20-60 patients completing long-term treatment per centre. The recruitment period will be about three months from the start of the study.
Study Hypothesis:
The primary objective of this study is to demonstrate the long-term safety of a fixed dose combination of telmisartan/HCTZ fixed-dose combination treatment. This study has no control group; therefore, no hypothesis testing will be performed.
Comparison(s):
This study has no control group.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Changes in clinical laboratory tests (haematology, blood chemistry and urinalysis)
时间窗: 52 weeks
Incidence of adverse events
时间窗: 52 weeks
Changes in electrocardiogram (ECG)
时间窗: 52 weeks
Changes in blood pressure and pulse rate
时间窗: 52 weeks
次要结局
- Seated blood pressure (BP) normality criteria(after 12 and 52 weeks)
- Changes in seated SBP(after 12 and 52 weeks)
- Seated DBP response rate(after 12 and 52 weeks)
- Seated SBP response rate(after 12 and 52 weeks)
- Changes in seated DBP(after 12 and 52 weeks)
- Seated Diastolic Blood Pressure (DBP) control rate(after 12 and 52 weeks)
- Seated Systolic Blood Pressure (SBP) control rate(after 12 and 52 weeks)