NCT01447485已完成1 期
A Multicenter, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Valsartan in Japanese Pediatric Patients 6 to 14 Years of Age
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- AUC of valsartan in plasma
研究概览
简要总结
This study will assess the pharmacokinetics and safety following single dose of valsartan in Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome
排除标准
- •GFR < 30 mL/min/1.73 m2
- •Inability to safely tolerate the temporary discontinuation of concomitant antihypertensive medications (expect amlodipine or atenolol) from 24 hours prior to study drug administration to study completion.
- •Inability to safely tolerate the temporary discontinuation of any drug known or suspected to effect hepatic or renal clearance capacity from 24 hours prior to study drug administration to study completion (this includes drugs that are known to cause induction or inhibition of hepatic enzymes).
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Valsartan 20 mg or 40 mg
Experimental
干预措施: Valsartan (VAL489) (Drug)
结局指标
主要结局
AUC of valsartan in plasma
时间窗: Up to 24 hours post-dose
T1/2 of valsartan in plasma
时间窗: Up to 24 hours post-dose
Tmax of valsartan in plasma
时间窗: Up to 24 hours post-dose
CL/F of valsartan in plasma
时间窗: Up to 24 hours post-dose
Cmax of valsartan in plasma
时间窗: Up to 24 hours post-dose
次要结局
- ECG evaluations(24 hours post-dose)
- Physical examination(24 hours post-dose)
- Number and severity of adverse events(Up to 24 hours post-dose)
- Standard clinical laboratory evaluations(24 hours post-dose)
- Vital signs(2, 4, and 24 hours post-dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543Congenital Bleeding DisorderHaemophilia ANCT01238367Novo Nordisk A/S6
已完成
1 期
Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01620424Novo Nordisk A/S10
已完成
1 期
A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid TumorsAdvanced Solid TumorsNCT02210663AbbVie16
招募中
4 期
Study of Bisoprolol (Nerkardou - Nerhadou International) 5 and 10 mg Oral Dissolvable Film (ODF) Treatment in Egyptian Patients With Essential HypertensionEssential HypertensionNCT05880056Genuine Research Center, Egypt406
已完成
1 期
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Emicizumab in Healthy Chinese VolunteersHealthy VolunteersHemophilia ANCT03380780Hoffmann-La Roche16