A 28 to 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren / Amlodipine / Hydrochlorothiazide in Patients With Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 564
- 试验地点
- 1
- 主要终点
- Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Death
研究概览
简要总结
This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in participants with essential hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Outpatients 18 years of age or older
- •Male or female participants are eligible.
- •Mean sitting diastolic blood pressure (msDBP) and mean sitting systolic blood pressure (msSBP) Requirements:
- •For newly diagnosed/untreated participants, msDBP ≥ 100 and < 120 millimeters of mercury (mmHg), and/or msSBP ≥ 160 and < 200 mmHg at Visit 1 and Visit
- •For previously treated participants, msDBP ≥ 100 and < 120 mmHg, and/or msSBP ≥ 160 and < 200 mmHg at Visit 2, Visit 3, or Visit
- •For participants requiring tapering off their previous antihypertensive medication, they must meet the above criteria and completely discontinue all antihypertensive treatment prior to entering the treatment phase of the study.
- •Participants who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
排除标准
- •Inability to discontinue all prior antihypertensive medications safely for a period of 1 week to 4 weeks as required by the protocol.
- •Participants on three antihypertensive drugs with msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg at Visit
- •Participants on four or more antihypertensive drugs at Visit
- •Participants with an msSBP ≥ 200 and msDBP ≥ 120 mmHg anytime during the washout period of the study Visit 1-4 must be discontinued from the study.
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (>= 5 milli-international units per milliliter mIU/mL).
研究组 & 干预措施
Aliskiren/Amlodipine/Hydrochlorothiazide
Participants received aliskiren 300 milligrams (mg) plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning.
干预措施: Aliskiren (Drug)
Aliskiren/Amlodipine/Hydrochlorothiazide
Participants received aliskiren 300 milligrams (mg) plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning.
干预措施: Amlodipine (Drug)
Aliskiren/Amlodipine/Hydrochlorothiazide
Participants received aliskiren 300 milligrams (mg) plus hydrochlorothiazide 12.5 mg for one week, at Week 1 followed by combination of aliskiren 300 mg plus amlodipine 5 mg plus hydrochlorothiazide 12.5 mg for one week, at Week 2. Following Week 2, participants were force titrated up to aliskiren 300 mg plus amlodipine 10 mg plus hydrochlorothiazide 25 mg for 26 to 52 weeks (Weeks 28 to 54). All study medications were taken orally with water, once daily in the morning.
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Death
时间窗: 54 weeks
An AE was defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug, even if the event is not considered to be related to study drug. An SAE was defined as an event which was fatal or life-threatening, resulted in persistent or significant disability/incapacity, constituted a congenital anomaly/birth defect, required inpatient hospitalization or prolongation of existing hospitalization, was medically significant, i.e. defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
次要结局
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)(Baseline, Weeks 28 and 54 endpoints)
- Percentage of Participants Achieving the Blood Pressure Control Target of <140/90 mmHg(Weeks 28 and 54 endpoints)
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)(Baseline, Weeks 28 and 54 endpoint)
- Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Diastolic Blood Pressure(Weeks 28 and 54 endpoints)
- Percentage of Participants Who Achieved a Blood Pressure Response in Mean Sitting Systolic Blood Pressure(Weeks 28 and 54 endpoints)