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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05562934 | An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients. | PHASE2 | COMPLETED | 189 | — | — | Nov 8, 2022 | Aug 27, 2024 | Jan 12, 2026 | 78 | United States, Australia +14 |
To evaluate the efficacy and dose-response relationship of different doses of XXB750 compared to placebo in reducing the mean 24 hours ambulatory systolic blood pressure from baseline at Week 12. Automated arterial BP determinations and pulse rate readings were made with Microlife Watch BP Office 2G, an automated digital BP device. The primary outcome measure was evaluated using an optimally weighted contrast test following the Multiple Comparison Procedure-Modeling (MCP-MOD) methodology. There were five candidate models to capture the shape of the dose-response relationship for XXB750 at Week 12 endpoint. The outcome for the single best candidate model is shown in the Statistical Analysis section.
| Arm | Type | Description |
|---|---|---|
| Dose 1 | EXPERIMENTAL | Lowest dose |
| Dose 2 | EXPERIMENTAL | Dose 2 |
| Dose 3 | EXPERIMENTAL | Dose 3 |
| Dose 4 | EXPERIMENTAL | Highest dose |
| Dose 5 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| XXB750 drug | BIOLOGICAL | SC injection |
| Placebo | OTHER | SC injection |
Inclusion Criteria: 1. Male and female participants who are ≥ 18 years old. 2. Signed informed consent prior to participation in the study. 3. Apparent rHTN at screening (Visit 1) defined as uncontrolled BP with an office msSBP ≥ 140 mmHg despite treatment with stable (i.e., unchanged for ≥4 weeks)...