Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure
NCT ID: NCT04318093
Last Updated: 2022-08-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2020-11-06
2021-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BMS-986259
BMS-986259
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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BMS-986259
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Participants must be hemodynamically stable, as assessed by the investigator
* Men must agree to follow specific methods of contraception, if applicable, while participating in the trial
* Women participants must have documented proof that they are not of childbearing potential
Exclusion Criteria
* Cardiogenic shock at presentation to emergency room (ER) or at any time before randomization
* Recipient of ventricular assist devices or use of any cardiac extracorporeal devices, within 12 weeks of study randomization
* Participants with contraindications to vasodilator therapy such as restrictive or obstructive cardiomyopathy, severe mitral or aortic stenosis
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0009
Ciudad de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0007
Alberdi, Córdoba Province, Argentina
Local Institution - 0028
Córdoba, Córdoba Province, Argentina
Local Institution - 0010
Córdoba, Córdoba Province, Argentina
Local Institution
Buenos Aires, Distrito Federal, Argentina
Local Institution - 0025
Córdoba, , Argentina
Local Institution - 0020
Prague, , Czechia
Nemocnice Slany-Interna - kardiologicka ambulance
Slaný, , Czechia
Local Institution - 0011
Athens, , Greece
Local Institution - 0022
Athens, , Greece
Local Institution - 0014
Tel Aviv, Tell Abīb, Israel
Local Institution
Jerusalem, , Israel
Local Institution
Petah Tikva, , Israel
Local Institution - 0034
Bialystok, , Poland
Local Institution - 0030
Wrocaw, , Poland
Local Institution - 0027
Wroclaw, , Poland
Local Institution
Edinburgh, , United Kingdom
Local Institution
Swindon, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Investigator Inquiry Form
Other Identifiers
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2019-004186-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV019-010
Identifier Type: -
Identifier Source: org_study_id
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