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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03357731 | A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function | PHASE2 | COMPLETED | 49 | — | — | Nov 30, 2017 | May 10, 2019 | Jul 27, 2020 | 18 | United States, Japan +2 |
| NCT03016325 | Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure | PHASE2 | COMPLETED | 329 | — | — | Jan 13, 2017 | Nov 12, 2019 | Jan 6, 2021 | 116 | United States, Argentina +11 |
The objective is to evaluate the effects of BMS-986231 on the left ventricular (LV) systolic function by stroke volume index (SVI) assessed by echocardiography compared to placebo.
Percentage of participants with clinically relevant hypotension, defined by systolic blood pressure (SBP) \< 90 mm Hg (confirmed by a repeated value \< 90 mm Hg) or symptoms of hypotension, up to 6 hours after the end of study drug infusion
| Arm | Type | Description |
|---|---|---|
| Placebo/BMS-986231/NTG | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| Placebo/NTG/BMS-986231 | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| NTG/Placebo/BMS-986231 | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| NTG/BMS-986231/Placebo | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| BMS-986231/Placebo/NTG | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| BMS-986231/NTG/Placebo | EXPERIMENTAL | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| Part 1 Cohort 1 HNO Donor | EXPERIMENTAL | - |
| Placebo Part 1 Cohort 1 | PLACEBO_COMPARATOR | - |
| Part 2 Cohort 2 HNO Donor- low dose | EXPERIMENTAL | - |
| Part 2 Cohort 2 HNO Donor- high dose | EXPERIMENTAL | - |
| Placebo Part 2 Cohort 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| HNO Donor | DRUG | Infusion |
| Nitroglycerin (NTG) | DRUG | Infusion |
| Placebo | OTHER | Infusion |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Heart failure with reduced ejection fraction (LVEF on echocardiogram of 40% or less) * Stable guideline directed therapy for heart failure including oral diu...