An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg Plus Amlodipine 5 mg Fixed-dose Combination vs. Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination in Patients With Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 8
- 主要终点
- Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough
研究概览
简要总结
Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug alone, often a combination of two or more drugs is essential to achieve a sufficient antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination therapy is recommended. In JSH 2009 it is advised to start the combination therapy at a low dose, and to increase the dosage when the antihypertensive effect is not sufficient. In the Japanese long-term safety study, 259 patients received the T40/A5 mg fixed-dose combination (FDC), and after 6 weeks treatment 48 patients of them could not control their blood pressure (DBP =90) (U09-2494-01). For those patients who cannot control their blood pressure with T40/A5 mg FDC, a switch to a higher dose such as T80/A5 mg is recommended.
In the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood pressure lowering effect between T80/A5 mg free combination and T40/A5 mg free combination was shown (U07-3503-02). But the sponsor has no data that verifies this difference in Japanese patients.
Thus, this clinical trial is being conducted to investigate the antihypertensive effect and safety of high dose T80/A5 mg FDC compared with low dose T40/A5 mg FDC in Japanese patients with essential hypertension. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.
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
- Double
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
80mg telmisartan and 5mg amlodipine FDC
once daily
干预措施: 80 mg telmisartan (Drug)
80mg telmisartan and 5mg amlodipine FDC
once daily
干预措施: 5 mg amlodipine (Drug)
40mg telmisartan and 5mg amlodipine FDC
once daily
干预措施: 40 mg telmisartan (Drug)
40mg telmisartan and 5mg amlodipine FDC
once daily
干预措施: 5 mg amlodipine (Drug)
结局指标
主要结局
Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough
时间窗: Reference baseline, 8 weeks
Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing
次要结局
- Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP(Reference baseline, 8 weeks)
- Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP(Reference baseline, 8 weeks)
- Seated DBP Control Rate at Trough(8 weeks)
- Seated SBP Control Rate at Trough(8 weeks)
- Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM(Reference baseline, 8 weeks)
- Seated DBP Response Rate at Trough(8 weeks)
- Seated SBP Response Rate at Trough(8 weeks)
- Seated Blood Pressure (BP) Normalisation at Trough(8 weeks)
- Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP(Pseudo-baseline, 14 weeks)
- Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP(Pseudo-baseline, 14 weeks)
- Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM(Reference baseline, 8 weeks)
- Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough(Reference baseline, 8 weeks)