E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Critically ill patients, male and female, admitted to hospital with decompensated chronic congestive heart failure and clinical indication for parenteral pharmacotherapy with invasive hemodynamic monitoring and a PCWP of higher or equal 18 mmHg. |
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MedDRA Classification |
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 |
The primary objective of part A is to investigate the hemodynamic and subjective effects on dyspnoea and well-being of 3 doses of BAY 58-2667 given intravenously over 2 hours per dose step in a dose escalation manner. In total, 3 dose steps per subject are planned.
The primary objective of part B is to investigate the hemodynamic effect of BAY 58-2667 given intravenously over 6 hours. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of part A is to investigate the safety, tolerability and pharmacokinetics of the respective dose levels.
The secondary objective of part B is to investigate the safety, tolerability and pharmacokinetics and subjective effects on dyspnoea of the respective dose levels of BAY 58-2667. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Critically ill patients, male and female, admitted to hospital with decompensated chronic congestive heart failure and clinical indication for parenteral pharmacotherapy with invasive hemodynamic monitoring and a PCWP of higher or equal 18 mmHg. ● Male patients older than 18 years of age. ●Postmenopausal female patients older than 55 years or women without childbearing potential based on surgical treatment like bilateral tubal ligation, bilateral ovarectomy or hysterectomy. ● Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period. ●Subjects must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures. |
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E.4 | Principal exclusion criteria |
● Women with childbearing potential; ● Heart Failure NYHA Class I + II; ● Acute heart failure; - RR < 100/60 mmHg - need for acute cardiologic intervention or surgery; - cardiogenic shock; - primary need for catecholamine; - need of invasive mechanical ventilation; ● Instable patient; ● Renal insufficiency creatinine 2 mg/dL = 177 µmol/L; ● Participation in another clinical trial during the preceding 3 months; ● Resting heart rate in the awake subject below 45 BPM or above 120 BPM; ● Relevant pathological changes in the ECG such as a second or third-degree AV block, ● Febrile illness within 1 week before the start of the study; ● Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies; ●A history of relevant diseases of the central nervous system or other organs; ● Subjects with a medical disorder, condition or history of such that would impair the subject’s ability to participate or complete this study in the opinion of the investigator or the sponsor; ● Subjects with hypersensitivity to the investigational drug, the control agent and/or to inactive constituents; |
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E.5 End points |
E.5.1 | Primary end point(s) | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 9 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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The date of final clean data base is defined as the end of the study. |
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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 | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |