Clinical Trial: A Phase 3 Pharmacokinetic Study of TAK-536 (Azilsartan) in Pediatric Patients 6 to Less Than 16 Years With Hypertension

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Takeda

Current Primary Outcome:

  • AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan) [ Time Frame: Pre-dose and at multiple time points (up to 24 hours) post-dose ]
    AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.
  • Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan) [ Time Frame: Pre-dose and at multiple time points (up to 24 hours) post-dose ]
    Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.
  • AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan) [ Time Frame: Pre-dose and at multiple time points (up to 24 hours) post-dose ]
    AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz
  • Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan) [ Time Frame: Pre-dose and at multiple time points (up to 24 hours) post-dose ]
    Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.
  • T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan) [ Time Frame: Pre-dose and at multiple time points (up to 24 hours) post-dose ]
    T1/2 is the terminal elimination half-life (time required for ha

    Original Primary Outcome:

    • Maximum observed plasma concentrations (Cmax) of of TAK-536 [ Time Frame: Up to Day 15 ]
      Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
    • Cumulative urinary excretion ratios of TAK-536 [ Time Frame: Up to 15 Days ]
      Urinary excretion rate of TAK-536 will be calculated from the urinary concentration and volume of each participant.


    Current Secondary Outcome:

    Original Secondary Outcome: Number of participants who experience at least 1 treatment-emergent adverse event [ Time Frame: Up to 15 Days ]

    The frequencies of all adverse events observed from the first dose of TAK-536 will be tabulated by type and seriousness. The adverse event is defined as any unfavorable and unintended sign, symptom, or disease that develops when a drug is administered, irrespective of the causal relationship to the drug.


    Information By: Takeda

    Dates:
    Date Received: May 19, 2015
    Date Started: August 2015
    Date Completion:
    Last Updated: March 8, 2016
    Last Verified: March 2016