Trial Condition(s):

Heart Failure

Single dose escalation study in patients with chronic heart failure

Bayer Identifier:

12356

ClinicalTrials.gov Identifier:

NCT00565565

EudraCT Number:

2007-003216-54

Study Completed

Trial Purpose

This study is to demonstrate the safety and tolerability of a single oral dose of BAY60-4552 in a single dose escalation design. Furthermore, this study examines the changes in hemodynamics after application of the test substance.42 hospitalized stable patients with chronic heart failure will be included. Several measurements will be performed to test how good the drug works and wether there are any unwanted reactions to the drug (e.g. blood tests, ECG, heart rate, blood pressure, adverse events). After a observation period the patient will be discharged from the hospital.

Inclusion Criteria
- Patients with chronic heart failure, undergoing routine invasive measurement of hemodynamic parameters
Exclusion Criteria
- Acute heart failure or acute decompensated heart failure, need for acute cardiologic intervention or surgery, severe renal or hepatic insufficiency, severe valvular disease

Trial Summary

Enrollment Goal
55
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Nelociguat (BAY60-4552)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Gießen, Germany, 35392

Status
Completed
 
Locations

Investigative Site

Bad Nauheim, Germany, 61231

Status
Completed
 

Trial Design