Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-28 @ 11:38 AM
Study NCT ID:
NCT02451150
Status:
COMPLETED
Last Update Posted:
2016-04-07
First Post:
2015-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 3 Pharmacokinetic Study of TAK-536 (Azilsartan) in Pediatric Patients 6 to Less Than 16 Years With Hypertension
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: