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darusentan · 4 trials · 3 indications
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| 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 |
| Group 1 | ACTIVE_COMPARATOR | Group 1 will receive oral darusentan 100mg for 2 weeks during Phase 1 then placebo for 2 weeks during Phase 2. |
| Group 2 | ACTIVE_COMPARATOR | Group 2 will receive placebo for 2 weeks during Phase 1 then oral darusentan 100 mg for two weeks during Phase 2 |
| 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 |
| darusentan 100 mg | DRUG | All subjects will receive oral darusentan 100 mg for a total of 2 weeks and placebo for 2 weeks. |
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...
Darusentan is an investigational small molecule being developed for cardiovascular conditions, specifically hypertension and coronary artery disease. In clinical trials, it has been studied for resistant hypertension, including resistant systolic hypertension, and for effects on endothelial dysfunction in coronary artery disease. It is not approved and remains in clinical development.
Darusentan is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. Gilead is conducting clinical trials to evaluate the drug's safety and efficacy in hypertension and coronary artery disease.
Darusentan is in Phase 2 clinical development. While some completed trials were Phase 3, the drug's current development stage is Phase 2. It is investigational and not FDA approved. All three completed trials have finished, and no active trials are currently ongoing.
Darusentan has been studied in three completed trials. NCT00330369 (DORADO) was a Phase 3 placebo-controlled trial in 352 patients with resistant hypertension. NCT00364026 was a Phase 2 trial in resistant systolic hypertension. NCT00389779 (DORADO-AC) was a Phase 3 active-controlled trial in 849 patients. NCT00738049 was a Phase 2 trial in 40 patients with coronary artery disease.
Darusentan is a small molecule developed for cardiovascular conditions. Its specific molecular target has not been disclosed in the available trial information. Clinical studies have evaluated its effects on blood pressure in resistant hypertension and on endothelial dysfunction in coronary artery disease.
No alternative names for darusentan have been identified in the available information. The drug is referred to solely as darusentan in clinical trial records and development documentation from Gilead Sciences.