A Randomized, Eight-week Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (300/5 mg and 300/10 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 818
- 试验地点
- 2
- 主要终点
- Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP)
研究概览
简要总结
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone
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 (Participant, Investigator)
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
- •Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a mean sitting Diastolic Blood Pressure (msDBP) ≥ 95 mmHg and < 110 mmHg at Visits 1 and 2
- •Patients who have been treated for hypertension within the 4 weeks prior to - Visit 1 must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 2
- •All patients must have a msDBP ≥ 90 mmHg and < 110 mmHg at Visit 4
排除标准
- •Severe hypertension
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential
- •Previous or current diagnosis of heart failure New York Heart Association (NYHA Class II-IV)
- •Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit 1
- •Uncontrolled Type 1 or Type 2 diabetes mellitus
- •Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
- •History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Aliskiren 300 mg/Amlodipine 5 mg
Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
干预措施: Aliskiren/Amlodipine 300/5 mg (Drug)
Aliskiren 300 mg/Amlodipine 5 mg
Participants received 1 Aliskiren/Amlodipine 300/5mg tablet + 1 Placebo to Aliskiren tablet once daily in the morning for 8 weeks.
干预措施: Placebo to Aliskiren (Drug)
Aliskiren 300 mg/Amlodipine 10 mg
Participants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks.
干预措施: Aliskiren/Amlodipine 300/10 mg (Drug)
Aliskiren 300 mg/Amlodipine 10 mg
Participants received 1 Aliskiren/Amlodipine 300/10 mg tablet + 1 Placebo to Aliskiren tablet orally once daily in the morning for 8 weeks.
干预措施: Placebo to Aliskiren (Drug)
Aliskiren 300 mg
Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
干预措施: Aliskiren 300 mg (Drug)
Aliskiren 300 mg
Participants received 1 Aliskiren 300 mg tablet + 1 Placebo to Aliskiren/Amlodipine tablet orally once daily in the morning for 8 weeks.
干预措施: Placebo to Aliskiren/Amlodipine (Drug)
结局指标
主要结局
Change From Baseline to End of Study in the Mean Sitting Diastolic Blood Pressure (msDBP)
时间窗: Baseline, End of Study (Week 8)
After the patient had been sitting for 5 minutes, systolic and diastolic blood pressures were measured 3 times using the automatic Blood Pressure monitor and appropriate size cuff. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting blood pressure for that visit. The difference of the msDBP at baseline from the msDBP at 8 weeks was calculated using an Analysis of Covariance (ANCOVA) model with baseline as a covariate and treatment and region as two factors.
次要结局
- Change From Baseline to End of Study in the Mean Sitting Systolic Blood Pressure (msSBP)(Baseline, End of Study (Week 8))
- Number of Participants With Serious Adverse Events and Adverse Events(8 weeks)
- Percentage of Participants Achieving Blood Pressure Control(8 weeks)
- Percentage of Participants Achieving a Diastolic Blood Pressure Response(8 weeks)
- Percentage of Participants Achieving a Systolic Blood Pressure Response(8 weeks)