Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-536 · 4 trials · 4 indications
An Adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant whose parent or legal guardian had signed informed consent form to participate in a study; it did not necessarily have to have a causal relationship with this treatment or study participation. An AE could therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study participation whether or not it was considered related to the drug or study procedures. A TEAE was defined as any AE occurring after the start of TAK-536 administration, and until the end of follow-up period of 2 weeks.
The relatedness of TEAEs with resting 12-lead ECG was based upon investigator discretion.
The anthropometric measurements included weight, height and body mass index (BMI). The relatedness of TEAEs to anthropometric measurements was based upon investigator discretion.
The laboratory values outside the range (triglycerides greater than \[\>\] 2.5\*upper limit of normal \[ULN\], blood urea nitrogen \[BUN\] \>30 milligram per deciliter \[mg/dL\], estimated glomerular filtration rate \[eGFR\] less than \[\<\] 30 milliliter per minute per 1.73 square meter \[mL/min/1.73m\^2\], and glucose \<50 mg/dL were considered markedly abnormal for TEAEs. The relatedness of TEAEs to clinical laboratory parameters was based upon investigator discretion.
Vital signs included home sitting blood pressure (diastolic and systolic) and office sitting pulse rate (pulse rate per 1 minute). The pulse rate measured at the last measurement of the sitting blood pressure was used as the sitting pulse rate value. The relatedness of TEAEs to vital signs was based upon investigator discretion.
| Arm | Type | Description |
|---|---|---|
| TAK-536 | EXPERIMENTAL | 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 10 mg (fasted) + TAK-536 10 mg (fed) | EXPERIMENTAL | TAK-536 10 milligram (mg) granule formulation (pediatric formulation), once daily on Day 1 of Period 1 (6 days) in the morning under fasted condition, followed by wash-out (6 days), followed by TAK-536 10 mg granule formulation (pediatric formulation), once daily on Day 1 of Period 2 (6 days) after starting breakfast. |
| TAK-536 10 mg (fed) + TAK-536 10 mg (fasted) | EXPERIMENTAL | TAK-536 10 mg granule formulation (pediatric formulation), once daily on Day 1 of Period 1 (6 days) after starting breakfast, followed by wash-out (6 days), followed by TAK-536 10 mg granule formulation (pediatric formulation), once daily on Day 1 of Period 2 (6 days) in the morning under fasted condition. |
| TAK-536 Granules + TAK-536 Tablet | EXPERIMENTAL | TAK-536 10 milligram (mg), granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2. |
| TAK-536 Tablet + TAK-536 Granules | EXPERIMENTAL | TAK-536 10 mg, tablet (commercial formulation), under fasted condition, orally, once on Day 1 of Intervention Period 1, followed by a Washout Period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), under fasted condition, orally, once on Day 1 of Intervention Period 2. |
| Dry syrup formulation (Group a) | EXPERIMENTAL | One pack of the dry syrup formulation of TAK-536, containing 10 milligram (mg) of TAK-536, will be orally administered with water (200 milliliter \[mL\]) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2. |
| Dry syrup formulation (Group b) | EXPERIMENTAL | One 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one pack of the dry syrup formulation of TAK-536, containing 10 mg of TAK-536, will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2. |
| Granule formulation (Group a) | EXPERIMENTAL | One pack of the granule formulation of TAK-536, containing 10 mg of TAK-536,will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2. |
| Granule formulation (Group b) | EXPERIMENTAL | One 10 mg tablet of TAK-536 will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 1 and, after a washout period of 6 days or more, one pack of the granule formulation of TAK-536, containing 10 mg of TAK-536, will be orally administered with water (200 mL) at breakfast to fasting participants who have fasted for 10 hours or longer since the night prior to the administration of study medication in Period 2. |
| Name | Type | Description |
|---|---|---|
| TAK-536 | DRUG | TAK-536 granule formulation |
| TAK-536 Tablet | DRUG | TAK-536 10 mg tablet |
| TAK-536 Dry Syrup Formulation | DRUG | TAK-536 dry syrup formulation |
| TAK-536 Ganule Formulation | DRUG | TAK-536 granule formulation |
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 protocol requirements. 2. The participant's parent or the participant's legal guardian is capable of signing and dating a written i...
TAK-536, also known as azilsartan, is an investigational small molecule being studied for hypertension (high blood pressure). It is also being evaluated in healthy volunteers and Japanese healthy adult males in early-phase trials. The drug is in clinical development for use in children aged 2 to less than 6 years with high blood pressure.
TAK-536 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials of this investigational small molecule in Japan, focusing on hypertension and related studies in healthy volunteers.
TAK-536 is in Phase 1 clinical development, with completed bioequivalence and food effect studies in healthy Japanese adult males. A Phase 3 study in children aged 2 to less than 6 years with high blood pressure has also been completed. The drug remains investigational and is not yet approved.
TAK-536 has completed several clinical trials in Japan, including NCT02401464 and NCT03042299, which are Phase 1 bioequivalence studies of the pediatric formulation in Japanese healthy adult males. NCT03434977 is a Phase 1 food effect study in healthy volunteers, and NCT04668157 is a Phase 3 study in children with high blood pressure.
Yes, TAK-536 is also known as azilsartan. Clinical trials such as NCT03434977, titled 'A Phase 1 Food Effect Study of Azilsartan (TAK-536) Pediatric Formulation,' use both names interchangeably. This investigational small molecule is being studied for hypertension and related conditions.
TAK-536 is an angiotensin II receptor blocker (ARB) that targets the angiotensin II type 1 (AT1) receptor. By blocking this receptor, it is intended to lower blood pressure in patients with hypertension. The drug is being studied in pediatric populations with high blood pressure.