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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04318093
Other study ID # CV019-010
Secondary ID 2019-004186-40
Status Completed
Phase Phase 2
First received
Last updated
Start date November 6, 2020
Est. completion date July 19, 2021

Study information

Verified date August 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to assess the safety of BMS-986259 in stable participants hospitalized for acute decompensated heart failure.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date July 19, 2021
Est. primary completion date July 19, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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: - Acute cardiovascular condition other than heart failure (HF) decompensation - 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 Other protocol-defined inclusion/exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BMS-986259
Specified dose on specified days
Other:
Placebo
Specified dose on specified days

Locations

Country Name City State
Argentina Local Institution - 0007 Alberdi Cordoba
Argentina Local Institution Ciudad Autónoma de Buenos Aires Distrito Federal
Argentina Local Institution - 0009 Ciudad de Buenos Aires Buenos Aires
Argentina Local Institution - 0025 Cordoba
Argentina Local Institution - 0028 Cordoba Provincia DE Cordoba
Argentina Local Institution - 0010 Córdoba Cordoba
Czechia Local Institution - 0020 Praha 2
Czechia Nemocnice Slany-Interna - kardiologicka ambulance Slany
Greece Local Institution - 0011 Athens
Greece Local Institution - 0022 Athens
Israel Local Institution Jerusalem
Israel Local Institution Petah Tikva
Israel Local Institution - 0014 Tel Aviv Tell Abib
Poland Local Institution - 0034 Bialystok
Poland Local Institution - 0030 Wrocaw
Poland Local Institution - 0027 Wroclaw
United Kingdom Local Institution Edinburgh
United Kingdom Local Institution Swindon

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Argentina,  Czechia,  Greece,  Israel,  Poland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
From first dose to 30 days following first dose
Secondary Maximum Observed Serum Concentration (Cmax) Day 1 and Day 5 of study treatment
Secondary Time of Maximum Observed Serum Concentration (Tmax) Day 1 and Day 5 of study treatment
Secondary Area Under the Concentration-Time Curve Within a Dosing Interval (AUC(TAU)) Day 1 and Day 5 of study treatment
Secondary Trough Concentration (Ctrough) Day 2 through Day 14 of study treatment (with the exception of Day 11, for which data is not available)
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