An 8-day Open-label, Multiple-dose, Multicenter Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients
研究概览
简要总结
This first open-label study in a pediatric population was designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with hypertension.
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
- None
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
- •Male or female, 6-17 years of age
- •Documented history of hypertension as defined in National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents (2004)
- •Must be ≥ 21.0 kg and ≤ 100.0 kg at randomization
- •Able to safely wash out previous antihypertensive therapy for 1-2 weeks
排除标准
- •Body weight of < 21 kg (45 lbs) or > 100 kg (220 lbs)
- •Inability to discontinue prior antihypertensive medication as required during the washout period
- •Any clinically significant abnormalities or clinically noteworthy abnormal laboratory values
- •Renal artery stenosis
- •Current diagnosis of heart failure (NYHA Class II-IV)
- •msSBP ≥ 25% above the 95th percentile for age, gender, and height at Visit 2
- •Second or third degree heart block with or without a pacemaker
- •Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any symptomatic arrhythmia during the 12 months prior to Visit 1
- •Evidence of current symptomatic valvular disease
- •Other protocol-defined inclusion/exclusion criteria applied to the study.
研究组 & 干预措施
Aliskiren 2 mg/kg
Oral mini-tablets (3.125 mg) of aliskiren dosed at 2 mg/kg body weight once each morning
干预措施: Aliskiren 3.125 mini-tablets (Drug)
Aliskiren 6 mg/kg
Oral mini-tablets (3.125 mg) of aliskiren dosed at 6 mg/kg body weight once each morning
干预措施: Aliskiren 3.125 mini-tablets (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients
时间窗: Day 1 and Day 8
Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.
Area Under the Plasma Concentration-time Curve (AUC0-τ) in One Dosing Interval (24 h) at Day 1 and Day 8 in 6-11 and 12-17 Year Old Patients
时间窗: Day 1 and Day 8
Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.
Apparent Plasma Clearance (CL/F) at Day 8 in 6-11 and 12-17 Year Old Patients
时间窗: Day 8
Blood samples (1 mL) for pharmacokinetic (PK) evaluation were drawn pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 10, and 24 hours following administration of aliskiren on Day 1 and Day 8. The pre-dose PK evaluations were collected in a fasted state (7-12 hours without food or beverage except water). PK parameters were calculated from plasma concentration-time data and actual recorded sampling times for each patient, using non-compartmental methods with the software program WinNonlin Pro v5.2.
次要结局
- Change in Plasma Renin Activity From Baseline on Day 1, Day 8, and Day 9(Baseline to 2 and 10 hours post-dose on Day 1; pre-dose, 2, 10, and 24 hours post-dose on Day 8-9)
- Change in Mean Sitting Systolic and Diastolic Blood Pressure (msSBP and msDBP) From Baseline to the End of Treatment (Day 9) in 6-11 and 12-17 Year Old Patients(Baseline to end of treatment (Day 9))