A research project to find out how safe and effective a single dose of TAK-491 research medicine is, after it has been taken by children aged 6 months – 16 years who have high blood pressure. Healthy adults will also be included in this research project to provide a comparison.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 29

Inclusion Criteria

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 30 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

Exclusion Criteria

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;
pregnancy.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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