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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06677060 | Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin | PHASE3 | RECRUITING | 11,300 | — | — | Mar 14, 2025 | Dec 17, 2029 | May 18, 2026 | 942 | United States, Argentina +33 |
Time to first occurrence of any of the components of the composite of: * Hospitalisation for HF * HF without hospitalisation * CV death
| Arm | Type | Description |
|---|---|---|
| Baxdrostat/Dapagliflozin | EXPERIMENTAL | Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose. |
| Placebo/Dapagliflozin | EXPERIMENTAL | Patients will receive a dose of dapagliflozin in combination with matching placebo |
| Name | Type | Description |
|---|---|---|
| Baxdrostat and dapagliflozin | DRUG | baxdrostat tablet and dapagliflozin tablet |
| Placebo and dapagliflozin | OTHER | placebo tablet and dapagliflozin tablet |
Inclusion Criteria: * Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent. * Diagnosed with T2DM and requiring treatment * Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease) * History of HTN and an...