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BMS-986259 · 2 trials · 2 indications
Clinically Relevant Hypotension is defined as occurrence of any of the following: * Supine Systolic Blood Pressure (SBP) \<85 mmHg (confirmed by repeat measurement within 30 minutes), regardless of symptoms of hypotension * Supine SBP \<90 mmHg (confirmed by repeat measurement within 30 minutes) AND symptoms of hypotension (eg, dizziness, lightheadedness, etc).
| Arm | Type | Description |
|---|---|---|
| BMS-986259 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Arm A: Normal Renal Function | EXPERIMENTAL | - |
| Arm B: Mild Renal Impairment | EXPERIMENTAL | - |
| Arm C: Moderate Renal Impairment | EXPERIMENTAL | - |
| Arm D: Severe Renal Impairment | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-986259 | DRUG | Specified dose on specified days |
| Placebo | OTHER | Specified dose on specified days |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Participants currently hospitalized for acute decompensated heart failure (ADHF) * Participants must be hemodynamically stable, as assessed by the investigat...
BMS-986259 is an investigational small molecule being developed by Bristol-Myers Squibb for cardiovascular and renal conditions. It has been studied in acute decompensated heart failure and in renal failure. It is not approved and remains in clinical development.
BMS-986259 has been studied for acute decompensated heart failure and for renal failure. One Phase 2 trial evaluated it in participants with post-acute decompensated heart failure, and a Phase 1 trial evaluated it in participants with various levels of kidney function. It is investigational and not approved for any use.
BMS-986259 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored both clinical trials of the drug, the Phase 2 heart failure study and the Phase 1 kidney function study.
BMS-986259 has completed a Phase 2 trial in post-acute decompensated heart failure and a Phase 1 trial in participants with various levels of kidney function. Both studies are completed, and no trials are currently active. The drug remains investigational and has not been approved by the FDA.
BMS-986259 has been evaluated in two completed trials. NCT04318093 was a Phase 2 study of its safety in participants with post-acute decompensated heart failure, enrolling 25 people across Argentina, Czechia, Greece, Israel, Poland, and the United Kingdom. NCT04237831 was a Phase 1 pharmacokinetics, safety, and tolerability study in participants with various levels of kidney function, enrolling 30 people in the United States.
No. BMS-986259 is an investigational drug and has not been approved by the FDA. Its clinical program consists of a completed Phase 2 trial in post-acute decompensated heart failure and a completed Phase 1 trial in renal failure, with no active trials at this time.