Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed for the treatment of essential hypertension and hypertension. It is a cardiovascular therapeutic that has been studied in clinical trials in Japan, including a Phase 3 long-term study in participants with essential hypertension.
TAK-536TCH is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is an investigational small molecule intended for the treatment of hypertension and essential hypertension.
TAK-536TCH has completed a Phase 3 clinical trial, making it an investigational drug that has advanced to late-stage clinical development. It is not approved and remains under investigation for the treatment of essential hypertension and hypertension.
TAK-536TCH has been studied in two completed trials in Japan. NCT02277691 was a Phase 3 long-term study in 341 participants with essential hypertension. NCT02348658 was a Phase 1 food effect study in 12 healthy male participants with hypertension.
TAK-536TCH is a distinct drug candidate from TAK-536, as indicated by its separate name. It is being developed by Takeda for hypertension and essential hypertension, and has completed Phase 3 testing.