An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of a 4 Week Therapy With Aliskiren 300 mg Plus Hydrochlorothiazide 25 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With Candesartan 32 mg Plus Hydrochlorothiazide 25 mg
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 186
- 试验地点
- 1
- 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 assess the safety and efficacy of aliskiren plus hydrochlorothiazide (HCTZ) in patients who do not achieve controlled blood pressure levels after treatment with another specified antihypertensive medication. There was an optional study extension for the first eligible 60 patients who wanted to participate that contains the triple therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg.
详细描述
Title of study extension: An open-label, multicenter extension to evaluate the efficacy and safety of a 4 week therapy with amlodipine 5 mg and aliskiren 300 mg plus HCTZ 25 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of candesartan 32 mg plus hydrochlorothiazide 25 mg followed by aliskiren 300mg plus hydrochlorothiazide 25 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
Candesartan+HCTZ, aliskiren+HCTZ, aliskiren+HCTZ+amlodipine
干预措施: Candesartan+HCTZ - Phase 1 (Drug)
Candesartan+HCTZ, aliskiren+HCTZ, aliskiren+HCTZ+amlodipine
干预措施: Aliskiren+HCTZ - Phase 2 (Drug)
Candesartan+HCTZ, aliskiren+HCTZ, aliskiren+HCTZ+amlodipine
干预措施: Aliskiren+HCTZ+amlodipine - Phase 3 (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 to end of Phase 3
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 to end of Phase 2
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
- Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study(Baseline Phase 2 to end of Phase 2)
- Change in Sitting Pulse Pressure During the Core Phase of the Study(Baseline Phase 2 to end of Phase 2)
- Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study(Baseline Phase 3 to end of Phase 3)
- Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study(Baseline Phase 3 to end of Phase 3)
- Change in Sitting Pulse Rate During the Core Phase of the Study(Baseline Phase 2 to end of Phase 2)
- Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study(Baseline Phase 3 to end of Phase 3)
- Change in Sitting Pulse Pressure During the Extension Phase of the Study(Baseline Phase 3 to end of Phase 3)
- Change in Sitting Pulse Rate During the Extension Phase of the Study(Baseline Phase 3 to end of Phase 3)