Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004186-40 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess the safety of BMS-986259 in stable participants hospitalized for acute decompensated heart failure.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986259 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986259 | Drug | Specified dose on specified days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Clinically Relevant Hypotension | Clinically Relevant Hypotension is defined as occurrence of any of the following:
| From first dose to 30 days following first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | Day 1 and Day 5 of study treatment | |
| Time of Maximum Observed Serum Concentration (Tmax) | Day 1 and Day 5 of study treatment | |
Not provided
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0009 | Ciudad de Buenos Aires | Buenos Aires | 1180 | Argentina | ||
| Local Institution - 0007 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls |
Not provided
25 participants were randomized and treated.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo matching BMS-986259 |
| FG001 | BMS-986259 3 mg | BMS-986259 administered subcutaneously QD for 14 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
Specified dose on specified days |
|
| Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU)) |
| Day 1 and Day 5 of study treatment |
| Trough Concentration (Ctrough) | Day 2 through Day 14 of study treatment (with the exception of Day 11, for which data is not available) |
| Alberdi |
| Córdoba Province |
| 5000 |
| Argentina |
| Local Institution - 0028 | Córdoba | Córdoba Province | 5000 | Argentina |
| Local Institution - 0010 | Córdoba | Córdoba Province | X5000EPU | Argentina |
| Local Institution | Buenos Aires | Distrito Federal | C1093AAS | Argentina |
| Local Institution - 0025 | Córdoba | 5006 | Argentina |
| Local Institution - 0020 | Prague | 12808 | Czechia |
| Nemocnice Slany-Interna - kardiologicka ambulance | Slaný | 274 01 | Czechia |
| Local Institution - 0011 | Athens | 11527 | Greece |
| Local Institution - 0022 | Athens | 142 33 | Greece |
| Local Institution - 0014 | Tel Aviv | Tell Abīb | 6423906 | Israel |
| Local Institution | Jerusalem | 912001 | Israel |
| Local Institution | Petah Tikva | 4941492 | Israel |
| Local Institution - 0034 | Bialystok | 15 276 | Poland |
| Local Institution - 0030 | Wrocaw | 50-556 | Poland |
| Local Institution - 0027 | Wroclaw | 54-049 | Poland |
| Local Institution | Edinburgh | EH16 4SA | United Kingdom |
| Local Institution | Swindon | SN3 6BB | United Kingdom |
| Investigator Inquiry Form | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo matching BMS-986259 |
| BG001 | BMS-986259 3 mg | BMS-986259 administered subcutaneously QD for 14 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Experiencing Clinically Relevant Hypotension | Clinically Relevant Hypotension is defined as occurrence of any of the following:
| All treated participants | Posted | Number | Percent of participants | From first dose to 30 days following first dose |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Maximum Observed Serum Concentration (Cmax) | All participants receiving study drug with available measurements | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 and Day 5 of study treatment |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Time of Maximum Observed Serum Concentration (Tmax) | All participants receiving study drug with available measurements | Posted | Median | Full Range | Hours | Day 1 and Day 5 of study treatment |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU)) | All participants receiving study drug with available measurements | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day 1 and Day 5 of study treatment |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Trough Concentration (Ctrough) | All participants receiving study drug with available measurements | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 2 through Day 14 of study treatment (with the exception of Day 11, for which data is not available) |
|
|
All-cause mortality was assessed from first dose to study completion date (up to approximately 8 months). SAEs and NSAEs were assessed from first dose to 30 days following first dose.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo matching BMS-986259 | 2 | 13 | 5 | 13 | 3 | 13 |
| EG001 | BMS986259 3 mg | BMS-986259 administered subcutaneously QD for 14 days | 0 | 12 | 2 | 12 | 8 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemoconcentration | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Jul 6, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Day 1 |
|
| ||||
| Day 5 |
|
|
| Day 1 |
|
| ||||
| Day 5 |
|
|
| Denominators |
|---|
| Categories |
|---|
| Day 1 |
|
| ||||
| Day 5 |
|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Day 2 |
|
| ||||
| Day 3 |
|
| ||||
| Day 4 |
|
| ||||
| Day 5 |
|
| ||||
| Day 6 |
|
| ||||
| Day 7 |
|
| ||||
| Day 8 |
|
| ||||
| Day 9 |
|
| ||||
| Day 10 |
|
| ||||
| Day 12 |
|
| ||||
| Day 13 |
|
| ||||
| Day 14 |
|
|