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Also known as TAK-536CCB tablet
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 developed by Takeda Pharmaceutical Company Limited for the treatment of Grade I or II essential hypertension. It has been studied in a Phase 2 clinical trial in Japan. It is a tablet formulation and is not yet approved for commercial use.
TAK-536CCB is being developed for the treatment of Grade I or II essential hypertension, a cardiovascular condition. Its clinical evaluation has focused on patients with this form of hypertension, specifically in a Phase 2 study conducted in Japan.
TAK-536CCB is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program evaluating this small molecule tablet for Grade I or II essential hypertension.
TAK-536CCB is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved for any indication.
TAK-536CCB has been evaluated in one completed Phase 2 trial, NCT02072330, titled a study of combined administration of TAK-536CCB and hydrochlorothiazide in patients with Grade I or II essential hypertension. The trial enrolled 353 patients in Japan and was randomized, double-blind, and active-controlled.
Yes, TAK-536CCB tablet is an alternative name for TAK-536CCB. Both refer to the same investigational small molecule developed by Takeda Pharmaceutical Company Limited for Grade I or II essential hypertension. The tablet form is the formulation used in its Phase 2 clinical trial.