Last updated on December 2018

A Phase 3 Long-term Study of TAK-536 in Pediatric Patients 6 to Less Than 16 Years With Hypertension


Brief description of study

The purpose of this study is to evaluate the safety of administration of TAK-536 in pediatric patients aged 6 to less than 16 years with hypertension.

Detailed Study Description

This is a phase 3, open-label, multicenter study to evaluate the safety, efficacy, and pharmacokinetics of long-term administration of TAK-536 once daily for 52 weeks in pediatric patients aged 6 to less than 16 years with hypertension. The study consists of a 2-week Run-in Period, a 52-week Treatment Period (Treatment Period I, 12-week; Treatment Period II, 40-week), and a 2-week Follow-up Period (56 weeks in total).

Participants eligible at screening will initiate to receive the placebo in a single-blinded fashion at the start of the Run-in Period.

Clinical Study Identifier: NCT02791438

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Recruitment Status: Closed


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