A Multicenter, Randomized, Double-blind, 8 Week Study to Evaluate the Dose Response, Efficacy and Safety of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1)
研究概览
简要总结
This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600 mg of aliskiren. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in children 6-17 years of age.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of hypertension as defined in the NHLBI 4th Report, 2004
- •msSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization) measurement as defined by the NHLBI 4th Report, 2004
排除标准
- •Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
- •Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or obstructive valvular disease
- •msSBP ≥ 25% above the 95th percentile
- •Second or third degree heart block without a pacemaker
- •AST/SGOT or ALT/SGPT >3 times the upper limit of the reference range
- •Total bilirubin > 2 times the upper limit of the reference range
- •Creatinine clearance < 30 mL/min/1.73m² (calculated using Modified Schwartz formula to estimate glomerular filtration rate [GFR]), based on the serum creatinine concentration obtained at the screening visit)
- •WBC count < 3000/mm³
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Low Dose Aliskiren
Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
干预措施: Aliskiren (6.25/12.5/25 mg) (Drug)
Mid dose
Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
干预措施: Aliskiren (37.5/75/150 mg) (Drug)
High dose
Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
干预措施: Aliskiren (150/300/600 mg) (Drug)
结局指标
主要结局
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1)
时间窗: Baseline to endpoint (Week 4 or Last observation carried forward (LOCF))
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Week 4 to Endpoint (Phase 2)
时间窗: Week 4 to endpoint (Week 8 or LOCF)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
次要结局
- Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1)(Baseline up to Week 4)
- Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2)(From Week 4 to Week 8)
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Endpoint (Phase 1)(Baseline to endpoint (Week 4 or LOCF))
- Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Week 4 to Endpoint (Phase 2)(Week 4 to endpoint (Week 8 or LOCF))
- Change From Baseline in Mean Arterial Pressure (MAP) at Endpoint (Phase 1)(Baseline to endpoint (Week 4 or LOCF))
- Change in Mean Arterial Pressure (MAP) From Week 4 to Endpoint (Phase 2)(Week 4 to endpoint (Week 8 or LOCF))
- Percentage of Participants Achieving a Positive Treatment Response at Endpoint (Phase 1)(Baseline to endpoint (Week 4 or LOCF))
- Change From Baseline in Mean Ambulatory Systolic and Diastolic Blood Pressure (MASBP and MADBP) at Endpoint (Phase 1)(Baseline to endpoint (Week 4 or LOCF))
- Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP) During Day and Night at Week 4 (Phase 1)(Baseline to Week 4)
- Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Dipper Participants at Endpoint (Phase 1)(Baseline to endpoint (Week 4 or LOCF))
- Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Non--Dipper Participants at Endpoint (Phase 1)(Baseline to endpoint (Week 4 or LOCF))