E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10019280 |
E.1.2 | Term | Heart failures |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To establish safety & tolerability of BMS-986259 when initiated inhospital in stabilized participants post-ADHF. |
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E.2.2 | Secondary objectives of the trial |
To evaluate serum PK parameters in participants with HF
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patients currently hospitalized for acute decompensated heart failure (ADHF) -Patients 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 - A female participant is eligible to participate if she is not pregnant or breastfeeding, and is not a WOCBP. - No healthy patients, only subjects |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of clinically relevant hypotension, defined as: - Supine SBP =< 85 mmHg (confirmed by repeat measurement within 30 minutes), regardless of symptoms of hypotension OR - Supine SBP =< 90 mmHg (confirmed by repeat measurement within 30 minutes) AND symptoms of hypotension |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Maximum observed plasma concentration (Cmax) - On day 5 2. Time of maximum observed plasma concentration (Tmax) - On day 5 3. Area under the concentrationtime curve in one dosing interval [AUC(TAU)] - On day 5 4. Concentration at 24 hours post-dose (C24) - On day 5 5. Incidence of Non-Serious Adverse Events - Up to 32 days 6. Incidence of Serious Adverse Events - Up to 70 days and up to 3 months for participants who develop Anti-Drug Antibody (ADA) 7. Incidence of clinically significant changes in vital signs of body temperature - Up to 22 days 8. Incidence of clinically significant changes in vital signs of respiratory rate - Up to 22 days 9. Incidence of clinically significant changes in vital signs of blood pressure - Up to 22 days 10. Incidence of clinically significant changes in vital signs of heart rate - Up to 22 days 11. Incidence of clinically significant changes in clinical laboratory tests of clinical chemistry - Up to 40 days 12. Incidence of clinically significant changes in clinical laboratory tests of hematology - Up to 40 days 13. Incidence of clinically significant changes in clinical laboratory tests of urinalysis - Up to 40 days 14. Incidence of clinically significant changes in electrocardiogram (ECG) parameters - Up to 22 days 15. Incidence of clinically significant changes from baseline in physical examination findings - Up to 22 days
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Endpoints from 1 to 4: On day 5 Endpoint 5: Up to 2 days Endpoint 6: Up to 70 days and up to 3 months for participants who develop Anti-Drug Antibody (ADA) Endpoints from 7 to 10 and from 14 to 15: Up to 22 days Endpoints from 11 to 13: Up to 40 days
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Israel |
Czechia |
Greece |
Netherlands |
Poland |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 13 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 10 |