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

Phase 3 Completed 6 enrolled Takeda

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2015-08
Primary completion: 2015-09
Completion: 2015-09

Publications

Enya K, Saji BT, Kato T, Okamoto H, Koumura E. Pharmacokinetics of a Single Dose of Azilsartan in Pediatric Patients: A Phase 3, Open-Label, Multicenter Study. Adv Ther. 2018 Aug;35(8):1181-1190. doi: 10.1007/s12325-018-0754-5. Epub 2018 Jul 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azilsartan	Unknown	5 mg	Oral
Subject	Azilsartan	Unknown	10 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications