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| ClinicalTrials.gov Identifier: NCT04318093 |
| Recruitment Status : Completed First Posted : March 23, 2020 Results First Posted : August 4, 2022 Last Update Posted : August 4, 2022 |
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation:Randomized; InterventionModel:ParallelAssignment; Masking:Quadruple(Participant,CareProvider,Investigator,OutcomesAssessor); PrimaryPurpose:Treatment |
| Condition | Acute Decompensated Heart Failure |
| Interventions | Drug: BMS-986259 Other: Placebo |
| Enrollment | 25 |
Participant Flow
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| Recruitment Details | |
| Pre-assignment Details | 25 participants were randomized and treated. |
| Arm/Group Title | Placebo | BMS-986259 3 mg |
|---|---|---|
 Arm/Group Description | Placebo matching BMS-986259 | BMS-986259 administered subcutaneously QD for 14 days |
| Period Title: Overall Study | ||
| Started | 13 | 12 |
| Completed | 10 | 9 |
| Not Completed | 3 | 3 |
| Reason Not Completed | ||
| Adverse Event | 2 | 2 |
| Participant withdrew consent | 1 | 0 |
| Other reasons | 0 | 1 |
Baseline Characteristics
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Top of Page Participant Flow Baseline Characteristics Outcome Measures Adverse Events Limitations and Caveats Information More Information
| Arm/Group Title | Placebo | BMS-986259 3 mg | Total | |
|---|---|---|---|---|
| Arm/Group Description | Placebo matching BMS-986259 | BMS-986259 administered subcutaneously QD for 14 days | Total of all reporting groups | |
| Overall Number of Baseline Participants | 13 | 12 | 25 | |
| Baseline Analysis Population Description | [Not Specified] | |||
| Age, Categorical Measure Type: Count of Participants Unit of measure: Participants | ||||
| Number Analyzed | 13 participants | 12 participants | 25 participants | |
| <=18 years | 0.0% | 0.0% | 0.0% | |
| Between 18 and 65 years | 4 30.8% | 6 50.0% | 10 40.0% | |
| >=65 years | 9 69.2% | 6 50.0% | 15 60.0% | |
| Age, Continuous Mean (Standard Deviation) Unit of measure: Years | ||||
| Number Analyzed | 13 participants | 12 participants | 25 participants | |
| 65.1 (12.18) | 63.1 (15.65) | 64.1 (13.69) | ||
| Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants | ||||
| Number Analyzed | 13 participants | 12 participants | 25 participants | |
| Female | 4 30.8% | 3 25.0% | 7 28.0% | |
| Male | 9 69.2% | 9 75.0% | 18 72.0% | |
| Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants | ||||
| Number Analyzed | 13 participants | 12 participants | 25 participants | |
| American Indian or Alaska Native | 0.0% | 0.0% | 0.0% | |
| Asian | 0.0% | 0.0% | 0.0% | |
| Native Hawaiian or Other Pacific Islander | 0.0% | 0.0% | 0.0% | |
| Black or African American | 0.0% | 0.0% | 0.0% | |
| White | 13 100.0% | 12 100.0% | 25 100.0% | |
| More than one race | 0.0% | 0.0% | 0.0% | |
| Unknown or Not Reported | 0.0% | 0.0% | 0.0% | |
Outcome Measures
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Adverse Events
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Limitations and Caveats
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Top of Page Participant Flow Baseline Characteristics Outcome Measures Adverse Events Limitations and Caveats Information More Information
[Not Specified]
More Information
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Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
| Name/Title: | Bristol-Myers Squibb Study Director |
| Organization: | Bristol-Myers Squibb |
| Phone: | Please email |
| EMail: | Clinical.Trials@bms.com |
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT04318093 |
| Other Study ID Numbers: | CV019-010 2019-004186-40 ( EudraCT Number ) |
| First Submitted: | March 20, 2020 |
| First Posted: | March 23, 2020 |
| Results First Submitted: | July 6, 2022 |
| Results First Posted: | August 4, 2022 |
| Last Update Posted: | August 4, 2022 |
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