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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05001945 | Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension | PHASE2 | COMPLETED | 200 | — | — | Jul 1, 2021 | Oct 7, 2022 | Jan 5, 2024 | 44 | United States |
The primary outcome was defined as the change in office-measured (mean of last 2 of 5 unattended measurements using an automated oscillometric sphygmomanometer device after approximately 5 minutes of rest in the seated position) SBP from baseline to the end of Study Week 8. The primary efficacy analysis was performed using a mixed model repeated measures (MMRM) approach with defined fixed effects per the statistical analysis plan. A least-square estimate of the mean difference between each dose group and the placebo group is provided for Week 8.
| Arm | Type | Description |
|---|---|---|
| Placebo (Part I) | PLACEBO_COMPARATOR | Placebo tablet(s) by mouth once or twice daily. |
| Dose 1 (Part I) | EXPERIMENTAL | MLS-101 tablet(s) by mouth once or twice daily. |
| Dose 2 (Part I) | EXPERIMENTAL | MLS-101 tablet(s) by mouth once or twice daily. |
| Dose 3 (Part I) | EXPERIMENTAL | MLS-101 tablet(s) by mouth once or twice daily. |
| Placebo (Part II) | PLACEBO_COMPARATOR | Placebo tablet(s) by mouth once daily. |
| Dose (Part II) | EXPERIMENTAL | MLS-101 tablet(s) by mouth once daily. |
| Name | Type | Description |
|---|---|---|
| MLS-101 (Part I) | DRUG | MLS-101 tablet(s) by mouth once or twice daily. |
| Placebo (Part I) | OTHER | Placebo tablet(s) by mouth once or twice daily. |
| Placebo (Part II) | OTHER | Placebo tablet(s) by mouth once daily. |
| MLS-101 (Part II) | DRUG | MLS-101 tablet(s) by mouth once daily. |
Inclusion Criteria: 1. Male and nonpregnant, nonlactating female subjects ≥ 18 years of age. 2. Written informed consent Health Insurance Portability and Accountability Act authorization, and local patient privacy required documentation for this study have been obtained 3. Automated office blood pr...