Trial Condition(s):

Heart Failure

BAY58-2667, iv dose titration over 6h infusion in patients

Bayer Identifier:

11615

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2005-004473-14

Study Completed

Trial Purpose

Primary objective:
Part A: To investigate the hemodynamic and subjective effects on dyspnea as well as well-being of the subjects following 3 intravenous (IV) doses of BAY 58-2667 given over 2 h per dose step in a dose escalation manner.
Part B: To investigate the hemodynamic effects of BAY 58-2667 given IV over 6 h.

Secondary objectives:
Part A: To investigate the safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of the respective dose levels.
Part B: To investigate the safety, tolerability, PD, PK, and subjective effects on dyspnea of the respective dose levels of BAY 58-2667.

Inclusion Criteria
- Critically ill subjects
- Male (older than 18 years ) and female (older than 55 years)
- Admitted to hospital with decompensated chronic CHF and clinical indication for parenteral pharmacotherapy with invasive hemodynamic monitoring and a pulmonary capillary wedge pressure of ≥18 mmHg 
- Postmenopausal female subjects or women without child bearing potential based on surgical treatment like bilateral tubal ligation, bilateral ovariectomy, or hysterectomy
Exclusion Criteria
- Women with childbearing potential; 
- Heart failure NYHA Class I and II
- Acute heart failure (blood pressure <100 mmHg systolic or <60 mmHg diastolic, need for acute cardiological intervention or surgery, cardiogenic shock, primary need for catecholamines, need for invasive mechanical ventilation)
- Unstable subjects
- Subjects with acute coronary syndrome; 
- Renal insufficiency with serum 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
- Medical disorders, condition or history that would impair the subject’s ability to participate or complete this study including the history of relevant diseases of vital organs, of the central nervous system; and 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 or with hypersensitivity to the investigational drug, the control agent and/ or to inactive constituents

Trial Summary

Enrollment Goal
60
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Cinaciguat (BAY58-2667)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

HELIOS Klinikum Erfurt GmbH

Erfurt, Germany, 99089

Status
Completed
 
Locations

St.-Johannes-Hospital Dortmund

Dortmund, Germany, 44137

Status
Completed
 
Locations

Evangelisches und Johanniter Klinikum

Duisburg, Germany, 47137

Status
Completed
 
Locations

Heliols Klinikum Wuppertal

Wuppertal, Germany, 42117

Status
Completed
 
Locations

Schüchtermann Klinik Herzzentrum Osnabrück/Bad Rothenfelde

Bad Rothenfelde, Germany, 49214

Status
Completed
 
Locations

Kerckhoff-Klinik GmbH

Bad Nauheim, Germany, 61231

Status
Completed
 
Locations

Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg

Halle, Germany, 06120

Status
Completed
 
Locations

Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55131

Status
Terminated
 

Trial Design