The purpose of the study is to assess the safety of BMS-986259 in stable participants hospitalized for acute decompensated heart failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
Specified dose on specified days
Specified dose on specified days
Local Institution - 0009
Ciudad de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0007
Alberdi, Córdoba Province, Argentina
Percentage of Participants Experiencing Clinically Relevant Hypotension
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).
Time frame: From first dose to 30 days following first dose
Maximum Observed Serum Concentration (Cmax)
Time frame: Day 1 and Day 5 of study treatment
Time of Maximum Observed Serum Concentration (Tmax)
Time frame: Day 1 and Day 5 of study treatment
Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU))
Time frame: Day 1 and Day 5 of study treatment
Trough Concentration (Ctrough)
Time frame: Day 2 through Day 14 of study treatment (with the exception of Day 11, for which data is not available)
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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
...and 8 more locations