Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-536CCB · 1 trial · 1 indication
Change in the office trough sitting DBP from the end of the placebo run-in period (baseline \[Week 0\]) to the end of the treatment period (Week 10, last observation carried forward \[LOCF\])
| Arm | Type | Description |
|---|---|---|
| TAK-536CCB 20 mg/5 mg ＋Placebo (dual therapy) | ACTIVE_COMPARATOR | TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide (HCTZ) placebo for 10 weeks |
| TAK-536CCB 20 mg/5 mg ＋HCTZ 6.25 mg (triple therapy) | EXPERIMENTAL | TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide placebo (triple therapy) for the first 2 weeks of the treatment period and TAK-536CCB 20 mg/5 mg and HCTZ 6.25 mg for the remaining 8 weeks. |
| TAK-536CCB 20 mg/5 mg ＋HCTZ 12.5 mg (triple therapy) | EXPERIMENTAL | TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide placebo for the first 2 weeks of the treatment period and TAK-536CCB 20 mg/5 mg and HCTZ 12.5 mg (triple therapy) for the remaining 8 weeks. |
| Placebo ＋HCTZ 6.25 mg (HCTZ monotherapy) | ACTIVE_COMPARATOR | TAK-536CCB placebo and Hydrochlorothiazide 6.25 mg (HCTZ monotherapy) for 10 weeks from the start of the treatment period. |
| Placebo ＋Hydrochlorothiazide 12.5 mg (HCTZ monotherapy) | ACTIVE_COMPARATOR | TAK-536CCB placebo and Hydrochlorothiazide 12.5 mg (HCTZ monotherapy) for 10 weeks from the start of the treatment period. |
| Name | Type | Description |
|---|---|---|
| TAK-536CCB | DRUG | TAK-536CCB 20 mg/5 mg ＋Hydrochlorothiazide placebo tablets |
| TAK-536CCB + Hydrochlorothiazide | DRUG | TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide 6.25 mg tablets |
| Hydrochlorothiazide | DRUG | TAK-536CCB placebo and Hydrochlorothiazide 6.25 mg tablets |
Inclusion Criteria: 1. Grade I or II essential hypertension. 2. An office sitting systolic blood pressure of ≥ 150 and \< 180 mmHg, and an office sitting diastolic blood pressure of ≥ 95 and \< 110 mmHg during the placebo run-in period at Week -2 and Week 0. 3. Male or female aged 20 years or older...
TAK-536CCB is an investigational small molecule being developed for the treatment of Grade I or II Essential Hypertension, a form of high blood pressure. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
TAK-536CCB is being developed by Takeda Pharmaceutical Company Limited, a biopharmaceutical company listed on the stock exchange under the ticker symbol TAK. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with essential hypertension.
TAK-536CCB is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The drug is being studied for the treatment of Grade I or II Essential Hypertension.
TAK-536CCB has one completed Phase 2 clinical trial registered under NCT02072330. This study evaluated the efficacy and safety of TAK-536CCB combined with hydrochlorothiazide in 353 patients with Grade I or II Essential Hypertension in Japan. The trial was randomized, double-blind, and active-controlled.
TAK-536CCB is a specific formulation or combination product that includes TAK-536. The name TAK-536CCB indicates a combination of TAK-536 with a calcium channel blocker (CCB). This drug is being studied for the treatment of essential hypertension.