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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01456169 | A Study to Evaluate the Effectiveness and Safety of a Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone in Patients With High Blood Pressure Who do Not Achieve Target Blood Pressure Following Treatment With Azilsartan Medoxomil Alone | PHASE3 | COMPLETED | 507 | — | — | Oct 1, 2011 | Jan 1, 2013 | Apr 23, 2014 | 108 | Bulgaria, Estonia +12 |
The change between trough systolic blood pressure measured at final visit or Week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.
| Arm | Type | Description |
|---|---|---|
| Azilsartan medoxomil 40 mg | ACTIVE_COMPARATOR | Azilsartan medoxomil 40 mg and placebo to chlorthalidone combination tablets, orally, once daily for up to 8 weeks. |
| Azilsartan medoxomil + chlorthalidone 40/12.5 mg | EXPERIMENTAL | Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks. |
| Azilsartan medoxomil + chlorthalidone 40/25 mg | EXPERIMENTAL | Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks. |
| Name | Type | Description |
|---|---|---|
| Azilsartan medoxomil/placebo | DRUG | Azilsartan medoxomil and placebo to chlorthalidone combination tablets |
| Azilsartan medoxomil - chlorthalidone | DRUG | Azilsartan medoxomil and chlorthalidone fixed dose combination tablets |
Inclusion Criteria: At Screening 1. The participant has grade 2-3 essential hypertension which is not adequately controlled, as defined by mean, trough, sitting, clinic systolic blood pressure (SBP): * ≥160 to ≤180 mm Hg in participants who have not received any antihypertensive medication in ...