NCT01070030已完成4 期
Multi-center, Open Label, 18-week Study to Demonstrate the Efficacy and Safety of Combination Therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Stage II HT
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 230
- 试验地点
- 3
- 主要终点
- Percentage of participants with stage II hypertension achieving blood pressure (BP) goal
研究概览
简要总结
This study assessed the efficacy and safety of combination therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in patients with stage II Hypertension.
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
- •Outpatients 18 years of age or older
- •Male or female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicidal or an intrauterine device.
- •Patients with a diagnosis of hypertension as following msDBP & msSBP Requirements:
- •For newly diagnosed/untreated patients:
- •Mean Sitting Diastolic Blood Pressure (msDBP) ≥ 100 and < 120 mmHg, and/or mean sitting Systolic Blood Pressure (msSBP) ≥ 160 and < 200 mmHg at Visit
- •For previously treated patients with 1 or 2 antihypertensive medications:
- •msDBP ≥ 90 and < 100 mmHg, and/or msSBP ≥ 140 and < 160 mmHg at Visit 1 AND
- •msDBP ≥ 100 and < 120 mmHg, and/or msSBP ≥ 160 and < 200 mmHg at Visit
- •For previously treated patients with Atenolol 50 mg once daily alone more than 2 weeks consecutively at visit 1:
- •msDBP ≥ 100 and < 120 mmHg, and/or msSBP ≥ 160 and < 200 mmHg.
- •Patients 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
- •Patients that previously participated in any Aliskiren study.
- •Inability to receive or completely replace all previous antihypertensive medications with Atenolol 50 mg once daily for a period of 2 weeks as required by the protocol.
- •Patients on 1 (other than Atenolol 50 mg once daily) or 2 antihypertensive drugs with msDBP ≥ 100 mmHg and/or msSBP ≥ 160 mmHg at Visit
- •Patients on 3 or more antihypertensive drugs at Visit
- •Pregnant or nursing (lactating) women, when pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (≥ 5 mIU/mL).
- •Sexually active female patients who are not using effective contraceptive methods.
- •Serum potassium <3.5 mEq/L (mmol/L) or > 5.5 mEq/L at Visit
- •Second or third degree heart block with or without a pacemaker, or other potentially life-threatening or symptomatic arrhythmia current or by history.
- •History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Percentage of participants with stage II hypertension achieving blood pressure (BP) goal
时间窗: 18 weeks
The BP goal for non-diabetic patient is defined as msSBP \< 140 mmHg and msDBP \< 90 mmHg. The BP goal for diabetic patient is msSBP \< 130 mmHg and msDBP \< 80 mmHg) in patients with stage II hypertension.
次要结局
- Percentage of participants who have blood pressure surge to their baseline level during 24-h ambulatory blood pressure monitor (ABPM)(18 weeks)
- Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to study end(From baseline to study completion (between week 8 to 18))
- Number of participants with responder rate for Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)(18 weeks)
- Number of patients with any adverse events(18 weeks)
研究者
研究点 (3)
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