An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 259
- 试验地点
- 7
- 主要终点
- Percentage of Participants Who Experienced Adverse Events
研究概览
简要总结
To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with essential hypertension
排除标准
- •Patients whose SBP >=180 mmHg or DBP >=110 mmHg at the end of treatment visit of the double-blind treatment period in the "non-responder trials"
- •Patients who have met any of the exclusion criteria defined in the "non-responder trials"
结局指标
主要结局
Percentage of Participants Who Experienced Adverse Events
时间窗: 52 weeks
An adverse event is defined as any untoward medical occurrence
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
时间窗: First administration of study treatment to 24 hours post last dosing of study treatment.
Clinically relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.
次要结局
- Change From Baseline in Seated Diastolic Blood Pressure at Week 8(Baseline and week 8)
- Change From Baseline in Seated Systolic Blood Pressure at Week 8(Baseline and week 8)
- Seated DBP Control Rate at Trough After 8 Weeks(week 8)
- Seated SBP Control Rate at Trough After 8 Weeks(Week 8)
- Change From Baseline in Seated Diastolic Blood Pressure(Baseline and week 20 / week 48)
- Change From Baseline in Seated Systolic Blood Pressure(Baseline and week 20 / week 48)
- Seated DBP Control Rate at Trough After 6 and 12 Months(6 months and 12 months)
- Seated SBP Control Rate at Trough After 6 and 12 Months(6 months and 12 months)
- Seated DBP Response Rate at Trough(6 months and 12 months)
- Seated SBP Response Rate at Trough(6 months and 12 months)
- Seated Blood Pressure Normalisation at Trough(6 months and 12 months)