Conditions: Pediatric Hypertension
Keywords: Drug therapy
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of TAK-536 (azilsartan) in pediatric patients aged 6 to less than 16 years with hypertension.

Detailed description:
The drug being tested in this study is called azilsartan. Azilsartan was being tested to evaluate how it is processed by the body (pharmacokinetics). This study looked at lab results in pediatric participants who took azilsartan.

The study enrolled 6 patients. Participants were assigned to study medication dose by body weight as follows:

* Body Weight \<50 kg: azilsartan 5 mg
* Body Weight ≥50 kg: azilsartan 10 mg

All participants took a single oral dose of azilsartan on Day 1 of the study.

This multi-center trial was conducted in Japan. The overall time to participate in this study was 17 days. Participants made multiple visits to the clinic, and were contacted by telephone on Day 6 and Day 15 after last dose of study drug for a follow-up assessment.

Arms:
arm 1: Weight \<50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1. arm 2: Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.

Interventions: intervention 1: Azilsartan
Intervention descriptions: intervention 1: Azilsartan tablets

Protocol document: