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

Pediatric Hypertension Clinical Trial

Official title:

An Open-label, Phase 3, Multicenter Study to Evaluate the Pharmacokinetics of a Single Oral Dose of TAK-536 in Pediatric Patients 6 to Less Than 16 Years of Age With Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451150
• Other study ID #: TAK-536/CPH-103
• Secondary ID: U1111-1169-6319
• Status: Completed
• Phase: Phase 3
• First received: May 19, 2015
• Last updated: January 6, 2016
• Start date: August 2015
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

Inclusion Criteria:

• 1. In the opinion of the investigator or subinvestigator, the participant's parent or legal guardian is capable of understanding and complying with the study requirements.

2. The participant's parent or legal guardian is capable of signing and dating a written informed consent form on behalf of the participant prior to the initiation of any study procedures. Written informed assent is also obtained from the participant as much as possible.

3. The participant is diagnosed as hypertensive (if the participant is not receiving antihypertensive therapy, the diagnosis will be based on the Age- and Gender-Based Blood Pressure Reference for Children. Sitting diastolic blood pressure [DBP] or systolic blood pressure [SBP] is to be in at least the 95th percentile if essential hypertension is present without concurrent hypertensive organ damage and at least the 90th percentile if secondary hypertension is present with concurrent chronic renal disease, diabetes mellitus, heart failure, or hypertensive organ damage).

4. The participant is male or female and aged 6 to less than 16 years at the time of consent.

5. The participant weighs at least 20 kg during the observation period. 6. The participant is capable of taking the tablets provided as study drug. 7. Participants after renal transplants should meet the following conditions: At least 6 months has elapsed from the transplant to the start of the observation period with stable graft function for more than 6 months (and eGFR = 30 mL/min/1.73 m2) and historical documentation (Doppler echo or CT, MRI, etc.) which verify that arterial stenosis is not present in the transplanted kidney. For participants receiving immunosuppressive therapy, the dose should have been stable at least 30 days before study drug administration.

8. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent to within 1 month after the completion of the study and have a negative pregnancy test result during the observation period.

Exclusion Criteria:

• 1. The participant received an investigational drug within 30 days prior to the start of the observation period or is currently participating in another clinical study or post-marketing study.

Note: This does not apply to participants participating in observational studies without interventional or invasive therapy.

2. The participant is determined to have poorly controlled hypertension (as a general guideline, when clinical sitting blood pressure is measured, SBP is to be at least 15 mmHg higher and/or DBP is to be at least 10 mmHg higher than the 99th percentile in the Age- and Gender-Based Blood Pressure Reference for Children).

3. The participant is diagnosed with malignant hypertension or rapidly progressive hypertension.

4. The participant has severe renal dysfunction (eGFR <30 mL/min/1.73 m2), dialysis treatment, renovascular disease affecting both kidneys or a solitary kidney, severe nephrotic syndrome not in remission, or serum albumin <2.5 g/dL.

5. The participant has a history or clinical manifestations of serious cardiovascular, hepatobiliary, gastrointestinal, endocrine (e.g., hyperthyroidism and Cushing's syndrome), hematologic, immunologic, genitourinary, or psychiatric disease; cancer; and/or any conditions that would interfere with the health status of the participant through study participation or would jeopardize study integrity in the opinion of the investigator or subinvestigator.

6. The participant has left ventricular outflow tract obstruction affecting hemodynamics due to aortic stenosis, aortic valve disease, or the like or is scheduled to have surgery affecting blood pressure (e.g., repair of arterial anomalies) during the study.

7. The participant underwent a surgical procedure with major bleeding within 6 months before the start of the observation period.

8. The participant has past or present clinically significant abnormalities on the 12-lead electrocardiogram and is ineligible for the study in the opinion of the investigator or subinvestigator.

9. The participant has poorly controlled diabetes mellitus (HbA1c >9.0% during the observation period) 10. The participant has any of either ALT or AST at least 2.5 times the upper limit of standard value or total bilirubin at least 1.5 times the upper limit of standard value, severe hepatic dysfunction, active liver disease (regardless of etiology), and jaundice during the observation period.

11. The participant has hyperkalemia exceeding the upper limit of standard value during the observation period.

12. The participant has a history of hepatitis B, hepatitis C, or human immunodeficiency virus infection at the start of the observation period.

13. The participant has a history of hypersensitivity or allergy to angiotensin II receptor blockers (ARBs).

14. The participant requires treatment with prohibited concomitant drug(s). 15. Peripheral venous blood collection from the participant is difficult. 16. The participant had a clinically significant acute disease within 30 days from the day before study drug administration.

17. If female, the participant is pregnant or lactating, or intending to become pregnant before giving consent, during the study period, or within 1 month after study completion.

Study Design

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

Related Conditions & MeSH terms

• Hypertension
• Pediatric Hypertension

Intervention

Drug:
• TAK-536 5 mg
TAK-536 tablets
• TAK-536 10 mg
TAK-536 tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentrations (Cmax) of of TAK-536	Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.	Up to Day 15	No
Primary	Cumulative urinary excretion ratios of TAK-536	Urinary excretion rate of TAK-536 will be calculated from the urinary concentration and volume of each participant.	Up to 15 Days	No
Secondary	Number of participants who experience at least 1 treatment-emergent adverse event	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.	Up to 15 Days	Yes