NCT02791438

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

A Phase 3, Open-label, Multicenter, Long-term Study to Evaluate the Safety, Efficacy and Pharmacokinetics 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: 27 (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 safety of administration of 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 is being tested to treat pediatric participants with hypertension. The study enrolled 27 participants. Following a 2-week Placebo Run-in Period, participants were assigned to one of the two treatment groups based on weight: * Azilsartan 2.5 - 20 mg (Participants \< 50 kg) * Azilsartan 5 - 40 mg (Participants ≥ 50 kg) Participants weighing \< 50 kg were asked to take an initial dose azilsartan 2.5 mg (titrated as needed to the highest dose of 20 mg) and participants weighing ≥ 50 kg were asked to take an initial dose of 5 mg azilsartan (titrated as needed to the highest dose of 40 mg). This multi-centre trial was conducted in Japan. The overall time to participate in this study is 56 weeks. The study consisted of a Run-in Period (Week -2 to Week 0), a 52-week Treatment Period, and a 2-week Follow-up Period (up to Week 54). Participants made multiple visits to the clinic and a final visit 2 weeks after the last dose of study drug for follow-up assessment.

Conditions

• Pediatric Hypertension

Interventions

Type	Name	Description
DRUG	Azilsartan	Azilsartan granules and tablets
DRUG	Placebo	Placebo-matching azilsartan granules and tablets

Timeline

• Start date: 2016-08-18
• Primary completion: 2019-06-04
• Completion: 2019-06-04
• First posted: 2016-06-06
• Last updated: 2020-02-07
• Results posted: 2019-12-23

Locations

30 sites across 1 country: Japan