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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00635232 | A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension | PHASE2 | COMPLETED | 261 | — | — | Mar 1, 2008 | Dec 1, 2008 | Sep 16, 2011 | 40 | United States |
| NCT00522925 | A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat Hypertension | PHASE2 | COMPLETED | 280 | — | — | Aug 1, 2007 | May 1, 2008 | Sep 16, 2011 | 15 | United States |
| Arm | Type | Description |
|---|---|---|
| Irbesartan 300mg | ACTIVE_COMPARATOR | Irbesartan 300 mg once daily |
| Placebo | PLACEBO_COMPARATOR | Blinded Placebo Treatment |
| PS433540 200mg | EXPERIMENTAL | PS433540 200mg once daily |
| PS433540 400mg | EXPERIMENTAL | PS433540 400mg once daily |
| PS433540 800mg | EXPERIMENTAL | PS433540 800mg once daily |
| 1 | PLACEBO_COMPARATOR | Matching Placebo |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| irbesartan | DRUG | 300 mg (2 x 150 mg capsules) once daily for 12 weeks |
| placebo | DRUG | placebo capsules once daily for 12 weeks |
| PS433540 | DRUG | 200 mg (2 x 100 mg capsules) once daily for 12 weeks |
Inclusion Criteria: * Males or females 18 - 70 years * Mean seated Systolic Blood Pressure (SBP) ≥ 140 mmHg and \< 180 mmHg and mean seated Diastolic Blood Pressure (DBP) \> 90 and \< 109 mmHg at two consecutive qualifying visits (Visits 3/3.5 and Visit 4). The mean difference in DBP between the tw...