NCT02451150

A Phase 3 Pharmacokinetic Study of TAK-536 (Azilsartan) in Pediatric Patients 6 to Less Than 16 Years With Hypertension

An Open-label, Phase 3, Multicenter Study to Evaluate the Pharmacokinetics Following a Single Oral Dose of TAK-536 in Pediatric Patients 6 to Less Than 16 Years of Age With Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatric Hypertension

Interventions

Type	Name	Description
DRUG	Azilsartan	Azilsartan tablets

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-05-21
• Last updated: 2016-04-07
• Results posted: 2016-04-07

Locations

3 sites across 1 country: Japan