Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02072330 | Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB and Hydrochlorothiazide in Patients With Grade I or II Essential Hypertension. | PHASE2 | COMPLETED | 353 | — | — | Mar 1, 2013 | Dec 1, 2013 | Feb 26, 2014 | 13 | Japan |
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...