Clinical Trial: A Phase 3 Long-term Study of TAK-536 in Pediatric Patients 6 to Less Than 16 Years With Hypertension
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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
Brief Summary: 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 Summary:
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.
Sponsor: Takeda
Current Primary Outcome:
- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 54 ]
- Number of Participants With TEAEs related to anthropometric measurements (weight, height and BMI) [ Time Frame: Up to Week 52 ]
- Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis [ Time Frame: Up to Week 52 ]
- Number of Participants with TEAEs related to resting 12-lead ECG [ Time Frame: Up to Week 52 ]
- Number of Participants with TEAEs related to vital signs [ Time Frame: Up to Week 54 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Office trough sitting systolic blood pressure [ Time Frame: Up to Week 54 ]
- Office trough sitting diastolic blood pressure [ Time Frame: Up to Week 54 ]
- Percentage of participants who achieve the target blood pressure [ Time Frame: Up to Week 54 ]Percentage of participants who achieve < 95 percentile shown in a table of the reference blood pressure values of children by gender and age for essential hypertension, < 90 percentile shown in the same table for secondary hypertension
- Cmax: Maximum Observed Plasma Concentration for TAK-536 [ Time Frame: Up to Week 16 ]
- Cmax: Maximum Observed Plasma Concentration for TAK-536 metabolites (M-I) [ Time Frame: Up to Week 16 ]
- Cmax: Maximum Observed Plasma Concentration for TAK-536 metabolites (M-II) [ Time Frame: Up to Week 16 ]
Original Secondary Outcome: Same as current
Information By: Takeda
Dates:
Date Received: June 1, 2016
Date Started: August 31, 2016
Date Completion: June 5, 2019
Last Updated: April 27, 2017
Last Verified: April 2017