An Open-label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Amlodipine 10 mg Plus Valsartan 160 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combination of an Angiotensin Receptor Blocker (Olmesartan 20 mg) Plus Amlodipine 10 mg
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 257
- 试验地点
- 2
- 主要终点
- Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study
研究概览
简要总结
This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).
详细描述
Title of study extension: An open-label, multicenter extension to evaluate the efficacy and tolerability of a 4 week therapy with hydrochlorothiazide 12.5 mg plus amlodipine 10 mg/valsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of olmesartan 20 mg plus amlodipine 10 mg followed by amlodipine 10 mg/valsartan 160 mg
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（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
Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ
During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
干预措施: Amlodipine (Drug)
Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ
During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
干预措施: Olmesartan medoxomil (Drug)
Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ
During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
干预措施: Amlodipine+valsartan (Drug)
Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ
During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study
时间窗: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study
时间窗: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
次要结局
- Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study(Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8))
- Change in Sitting Pulse Pressure During the Core Phase of the Study(Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8))
- Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study(Baseline of Phase 2 (Week 4) to end of Phase 2 (Week 8))
- Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study(Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12))
- Change in Sitting Pulse Rate During the Extension Phase of the Study(Baseline Phase 3 (Week 8) to end of Phase 3 (week 12))
- Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study(Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8))
- Change in Sitting Pulse Rate During the Core Phase of the Study(Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8))
- Change in Sitting Pulse Pressure During the Extension Phase of the Study(Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12))
- Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study(Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12))
- Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study(Baseline of Phase 3 (Week 8) to end of Phase 3 (Week 12))