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Clinical Trial Summary

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


Clinical Trial Description

This is an open-label, phase 3, multicenter study to evaluate the pharmacokinetics and safety of a single oral dose of TAK-536 in pediatric patients aged 6 to less than 16 years with hypertension.

The subjects will be admitted to hospital by the day before study drug administration, and a single dose of TAK-536 will be administered: TAK-536 5 mg to subjects weighing less than 50 kg and TAK-536 10 mg to subjects weighing 50 kg or more. ;


Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02451150
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 3
Start date August 2015
Completion date September 2015

See also
  Status Clinical Trial Phase
Completed NCT00244634 - Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age Phase 3
Terminated NCT03783650 - Boosting Primary Care Awareness and Treatment of Childhood Hypertension N/A
Completed NCT02791438 - A Phase 3 Long-term Study of TAK-536 in Pediatric Patients 6 to Less Than 16 Years With Hypertension Phase 3
Completed NCT03461003 - N-of-1 Trials In Children With Hypertension Phase 4