Single Dose Escalation Study in Patients With Chronic Heart Failure - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00565565

Purpose

This study is to demonstrate the safety and tolerability of a single oral dose of BAY 60-4552 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.

Condition	Intervention	Phase
Chronic Heart Failure	Drug: BAY 60-4552	Phase I

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Proof of Concept Study to Investigate Safety, Tolerability, Pharmacokinetics and the Impact on Pulmonary and Systemic Hemodynamics of a Single Oral Dose of BAY 60-4552 in Patients With Biventricular Chronic Heart Failure and Pulmonary Hypertension in a Non-Randomized, Non-Blinded, Dose Escalation Design.

Further study details as provided by Bayer:

Primary Outcome Measures:

To investigate the safety, tolerability, pharmacokinetics and the impact on pulmonary and systemic hemodynamics [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Enrollment:	42
Study Start Date:	October 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: BAY 60-4552 Single dose escalation starting with 1 mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565565

Locations

Germany, Hessen

Bad Nauheim, Hessen, Germany, 61231

Gießen, Hessen, Germany, 35392

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer HealthCare AG ( Head Clinical Pharmacology )
Study ID Numbers:	12356, EudraCT Nr: 2007-003216-54
Study First Received:	October 31, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00565565
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Chronic Heart Failure

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Hypertension, Pulmonary
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009