Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TAK-536TCH tablet
TAK-536TCH · 2 trials · 2 indications
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Vital signs included supine and standing systolic and diastolic blood pressure (SBP and DBP) respectively and office sitting pulse. Vital signs were considered abnormal if they were beyond the values defined in categories.
Reported TEAE is categorized into investigations System Organ Class (SOC) related to body weight.
Reported TEAE is categorized into cardiac disorders and investigations system organ class (SOC) related to ECG.
The number of participants with any markedly abnormal clinical laboratory test values collected throughout study. RBC = Red blood cells, ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyl transferase, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit. Laboratory vallues were considered abnormal if they were beyond the values defined in categories.
AUC(0-48) is a measure of the area under the plasma concentration time-curve from time 0 to 48 hours postdose.
AUC(0-120) is a measure of the area under the plasma concentration time-curve from time 0 to 120 hours postdose.
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Urinary excretion ratio (percent \[%\] of dose) of TAK-536, its metabolite M-I, M-II and HCTZ in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.
Urinary excretion ratio (% of dose) of AML in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.
| Arm | Type | Description |
|---|---|---|
| TAK-536TCH | EXPERIMENTAL | For 4 weeks during the run-in period, one tablet of TAK-536CCB (as TAK-536/AML, 20 mg/5 mg, respectively) orally, once daily, before or after breakfast. For 48 weeks during 52 weeks of the treatment period, one tablet of TAK-536TCH (as TAK-536/AML/HCTZ, 20 mg/5 mg/12.5 mg, respectively) orally, once daily, before or after breakfast. For the remaining 4 weeks of the treatment period, one tablet each of TAK-536CCB and HCTZ 12.5 mg orally, once daily, before or after breakfast. |
| Fasted dosing followed by fed dosing | OTHER | Dosing in the fasted state followed by fed dosing |
| Fed dosing followed by fasted dosing | OTHER | Dosing in the fed state followed by fasted dosing |
| Name | Type | Description |
|---|---|---|
| TAK-536TCH tablet | DRUG | TAK-536TCH tablets |
| TAK-536CCB tablet | DRUG | TAK-536CCB tablets |
| HCTZ 12.5 mg tablet | DRUG | HCTZ tablets |
| TAK-536TCH | DRUG | TAK-536TCH tablets |
Inclusion Criteria: 1. In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant signs and dates a written informed consent form prior to the initiation of any study procedures. 3. The participant ...
TAK-536TCH is an investigational small molecule tablet developed by Takeda Pharmaceutical Company Limited for the treatment of hypertension, including essential hypertension. It is being studied as an oral therapy in Japan. TAK-536TCH is also known as the TAK-536TCH tablet.
TAK-536TCH is being developed to treat essential hypertension, the most common form of high blood pressure. Its clinical program includes a Phase 3 long-term study in participants with essential hypertension in Japan, as well as an earlier Phase 1 food effect study in participants with hypertension.
TAK-536TCH is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical studies evaluating the drug in hypertension, including a Phase 3 long-term trial conducted in Japan.
TAK-536TCH has reached Phase 3 development. A Phase 3 long-term study of TAK-536TCH in participants with essential hypertension has been completed, and a Phase 1 food effect study of the final formulation tablet has also been completed. The drug remains investigational.
TAK-536TCH has been studied in two completed trials. NCT02277691 was a Phase 3 long-term study in participants with essential hypertension that enrolled 341 participants in Japan. NCT02348658 was a Phase 1 food effect study of the TAK-536TCH final formulation tablet that enrolled 12 healthy male volunteers in Japan.
Yes. TAK-536TCH tablet is an alternative name for TAK-536TCH, referring to the same oral tablet formulation developed by Takeda. The Phase 1 food effect study NCT02348658 specifically evaluated the final formulation tablet of TAK-536TCH.