A Study of TAK-536 in Children From 2 to Less Than 6 Years Old With High Blood Pressure
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|ClinicalTrials.gov Identifier: NCT04668157|
Recruitment Status : Not yet recruiting
First Posted : December 16, 2020
Last Update Posted : March 17, 2021
The main aim of this study is to check the safety of TAK-536. This study will take place in Japan. At the first visit, the study doctor will check if each child can take part. For those who can take part, each participant will have a check-up by the study doctor. This might take 2 weeks or longer.
After this, parents or the caregivers of each participant will be given sachets that contain granules of TAK-536 to give to that participant. The participants will take the TAK-536 granules once a day for 52 weeks.
After treatment has finished, participants will visit the study clinic for a final check-up.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: TAK-536||Phase 3|
The drug being tested in this study is called TAK-536. TAK-536 is being tested in pediatric participants with hypertension aged 2 to less than 6 years. This study will look at the safety, efficacy, and pharmacokinetics of long-term administration of TAK-536.
The study will enroll 10 participants. Participants will receive the study drug (TAK-536) orally once daily before or after breakfast.
The initial dose of TAK-536 will be 0.1 mg/kg (not exceeding 2.5 mg/day). After the initial dose, TAK-536 will be titrated to 0.2 mg/kg (not exceeding 5 mg/day), 0.4 mg/kg (not exceeding 10 mg/day), and 0.8 mg/kg (not exceeding 20 mg/day) if the participants do not achieve the target blood pressure and no concerns are found in safety and tolerability.
This multi-center trial will be conducted in Japan. The overall time to participate in this study is approximately 56 weeks. Participants will make multiple visits to the clinic.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Open-label, Multicenter, Long-term Study to Evaluate the Safety, Efficacy and Pharmacokinetics of TAK-536 in Pediatric Subjects From 2 to Less Than 6 Years of Age With Hypertension|
|Estimated Study Start Date :||March 16, 2021|
|Estimated Primary Completion Date :||January 22, 2024|
|Estimated Study Completion Date :||January 22, 2024|
TAK-536 granule formulation, orally once daily before or after breakfast. The initial dose of TAK-536 will be 0.1 mg/kg (not exceeding 2.5 mg/day). After the initial dose, TAK-536 will be titrated to 0.2 mg/kg (not exceeding 5 mg/day), 0.4 mg/kg (not exceeding 10 mg/day), and 0.8 mg/kg (not exceeding 20 mg/day) if the subjects do not achieve the target blood pressure and no concerns are found in safety and tolerability.
TAK-536 granule formulation
- Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) [ Time Frame: 54 Weeks ]
- Number of Participants with TEAE Related to 12-lead Electrocardiograms [ Time Frame: 54 Weeks ]
- Number of Participants with TEAE Related to Anthropometric Measurement (Weight, Height and Body Mass Index (BMI)) [ Time Frame: 54 Weeks ]
- Number of Participants with TEAE Related to Clinical Laboratory Tests [ Time Frame: 54 Weeks ]
- Number of Participants with TEAE Related to Vital Sign (Office Sitting Pulse Rate and Home Sitting Blood Pressure) [ Time Frame: 54 Weeks ]
- Change from baseline in office trough sitting diastolic blood pressure at Week 12 and 52 (last observation carried forward [LOCF]) [ Time Frame: Baseline, up to Week 12 and 52 ]
- Change from baseline in office trough sitting systolic blood pressure at Week 12 and 52 (last observation carried forward [LOCF]) [ Time Frame: Baseline, up to Week 12 and 52 ]
- Percentage of participants who achieve the target blood pressure at Week 12 and 52 (LOCF) [ Time Frame: Baseline, up to Week 12 and 52 ]The target blood pressure is defined as the normal reference range for blood pressure by age according to Guidelines on the Clinical Examination for Decision Making of Diagnosis and Drug Therapy in Pediatric Patients with Cardiovascular Diseases by the Japanese Circulation Society JCS 2018 (JCS 2018).
- Cmax: Maximum Observed Plasma Concentration for TAK-536 [ Time Frame: Pre-dose and 2 hours post-dose ]
- AUC: Area Under the Concentration-Time Curve for TAK-536 [ Time Frame: Pre-dose and 2 hours post-dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04668157
|Contact: Takeda Study Registration Call Center||+1-877-825-3327||medinfoUS@takeda.com|
|Japanese Red Cross Nagoya Daini Hospital|
|Nagoya, Aichi, Japan|
|Aichi Children's Health and Medical Center|
|Obu, Aichi, Japan|
|Hyogo Prefectural Kobe Children's Hospital|
|Kobe, Hyogo, Japan|
|National Hospital Organization Kanazawa Medical Center|
|Kanazawa, Ishikawa, Japan|
|Miyagi Children's Hospital|
|Sendai, Miyagi, Japan|
|Tohoku University Hospital|
|Sendai, Miyagi, Japan|
|Okinawa Prefectural Nanbu Medical Center & Children's Medical Center|
|Shimajiri-gun, Okinawa, Japan|
|Jichi Medical University Hospital|
|Shimotsuke, Tochigi, Japan|
|Tokyo Metropolitan Children's Medical Center|
|Fuchu, Tokyo, Japan|
|Hiroshima Prefectural Hospital|
|Saitama Children's Medical Center|
|Shizuoka Childrens Hospital|
|Wakayama Medical University Hospital|
|Study Director:||Study Director||Takeda|