Single Dose Escalation Study in Patients With Chronic Heart Failure

Bayer

Status and phase: Completed; Phase 1

Conditions: Heart Failure

Treatments: Drug: BAY60-4552

Study type: Interventional

Funder types: Industry

Identifiers

NCT00565565

12356

2007-003216-54 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 5 patient groups

BAY60-4552, 1 mg

Experimental group

Description:

Subjects were planned to receive 1 mg of BAY60-4552 as solution

Treatment:

Drug: BAY60-4552

BAY60-4552, 2.5 mg

Experimental group

Description:

Subjects were planned to receive 2.5 mg of BAY60-4552 as tablet

Treatment:

Drug: BAY60-4552

BAY60-4552, 5 mg

Experimental group

Description:

Subjects were planned to receive 5.0 mg of BAY60-4552 as tablet

Treatment:

Drug: BAY60-4552

BAY60-4552, 7.5 mg

Experimental group

Description:

Subjects were planned to receive 7.5 mg of BAY60-4552 as tablet

Treatment:

Drug: BAY60-4552

BAY60-4552, 10 mg

Experimental group

Description:

Subjects were planned to receive 10 mg of BAY60-4552 as tablet

Treatment:

Drug: BAY60-4552