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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00389779 | DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension | PHASE3 | COMPLETED | 849 | — | — | Sep 1, 2006 | Aug 1, 2009 | Mar 18, 2014 | 147 | United States, Argentina +8 |
| NCT00330369 | DORADO - Fixed Doses of Darusentan as Compared to Placebo in Resistant Hypertension | PHASE3 | COMPLETED | 352 | — | — | Jun 1, 2006 | Jan 1, 2009 | Mar 18, 2014 | 115 | United States, Argentina +9 |
| NCT00364026 | A Clinical Study to Evaluate the Effects of Darusentan on Safety and Efficacy in Subjects With Resistant Systolic Hypertension Receiving Combination Therapy With Three or More Blood Pressure Lowering Drugs | PHASE2 | COMPLETED | - | — | — | Jun 1, 2004 | Jul 1, 2005 | Jan 18, 2007 | - | — |
| Arm | Type | Description |
|---|---|---|
| Darusentan | EXPERIMENTAL | Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily for 14 weeks |
| Guanfacine | ACTIVE_COMPARATOR | Placebo to match darusentan for 2-week placebo run-in period, followed by guanfacine 1 mg capsules administered orally once daily for 14 weeks |
| Darusentan Placebo | PLACEBO_COMPARATOR | Placebo to match darusentan for 2-week placebo run-in period, followed by placebo to match darusentan administered orally once daily for 14 weeks |
| Darusentan 50 mg | EXPERIMENTAL | Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 50 mg administered orally once daily for 14 weeks |
| Darusentan 100 mg | EXPERIMENTAL | Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 100 mg administered orally once daily for 14 weeks |
| Darusentan 300 mg | EXPERIMENTAL | Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 300 mg administered orally once daily for 14 weeks |
| Name | Type | Description |
|---|---|---|
| Darusentan | DRUG | Darusentan capsules administered orally once daily |
| Guanfacine | DRUG | Guanfacine capsules administered orally once daily |
| Darusentan Placebo | DRUG | Placebo to match darusentan administered orally once daily |
SELECTED INCLUSION CRITERIA: 1. Subjects who are competent to provide written consent; 2. Aged 35 to 80 years; 3. Subjects with diabetes and/or chronic kidney disease must have an average sitting systolic blood pressure greater than or equal to 130 mmHg; 4. All other subjects must have an average s...