EUCTR2009-013165-25-Outside-EU/EEA进行中（未招募）不适用
A Comparative Single-Dose Pharmacokinetic and Safety Study of TAK-491 BetweenInfants, Children, and Adolescents with Hypertension and Healthy Adults
Takeda Global Research & Development Centre (Europe) Ltd.0 个研究点目标入组 32 人开始时间: 2013年5月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Main Criteria for Inclusion:
- •Pediatric subjects:
- •boys or girls must have a diagnosis of hypertension (SBP and / or DBP = 95th percentile for gender / age / height), aged =6 months to <17 years, subjects 6 years of age and older must have the ability to swallow a tablet;
- •subjects qualifying for Cohorts 1 and 2 must weigh at least 20 kg and up to 100 kg; subjects qualifying for Cohort 3 must weigh at least 6.5kg;
- •subjects must have been at a constant weight, or expected weight gain for that particular age, for 30 days with no change to the dose of their diuretic drugs;
- •subjects in Cohort 3 may be a renal transplant patient if all other inclusion and none of the exclusion criteria are met, time post-transplant has been > 6 months prior to Check-in (Day-1) with stable graft function (and estimated GFR =30mL/min/1.73 m2) for at least 6 months, with no change to medications such as immunosuppressive therapy for at least 60 days prior to Check-in (Day-1), and no evidence of transplant renal artery stenosis or anemia.
- •Adult subjects for Cohort 1: must be healthy male or females;
- •aged 18 to 45 years, inclusive;
- •have diastolic blood pressure (DBP) between 60 and 90 mm Hg, and systolic blood pressure (SBP) between 100 and 140 mm Hg, inclusive at Screening or Check-in (Day-1);
- •have a minimum body weight of 50kg, with a body mass index of 18 to 32 kg/m2 (inclusive) at Screening.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Main Criteria for Exclusion:
- •Pediatric subjects:
- •current treatment with more than 2 antihypertensive agents;
- •sitting trough clinical SBP/DBP exceeding the 99th percentile for age/gender/height by >15/>10 mm Hg;
- •the subject has renovascular disease affecting both kidneys or solitary kidney, including dialysis treatment, severe nephrotic syndrome not in remission;
- •for Cohorts 1 and 2 only a previous renal transplant.
- •All subjects:
- •history or clinical manifestations of significant disorders;
- •acute, clinically significant illness within 30 days prior to check-in (Day-1); hemodynamically significant left ventricular outflow obstruction due to aortic
- •valvular disease, cardiomyopathy, or uncorrected aortic coarctation;
- •diagnosis of malignant or accelerated hypertension;
- •severe hepatic impairment;
- •alanine aminotransferase, aspartate aminotransferase >2 times the upper limit of normal, or total bilirubin >1.5 times the upper limit of normal;
- •glycosylated hemoglobin >8.5%;
- •hyperkalemia;
- •creatinine clearance <30 mL/min/1.73 m2;
- •serum albumin <2.5 g/dL;
- •intake of potent CYP enzyme inducers or inhibitors or any other prespecified excluded medication, allergy to an angiotensin type II receptor blocker or any of the excipients;
研究者
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