Single Dose Escalation Study in Patients With Chronic Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00565565
First received: October 31, 2007
Last updated: May 5, 2013
Last verified: May 2013

October 31, 2007
May 5, 2013
October 2007
December 2008   (final data collection date for primary outcome measure)
To investigate the safety, tolerability, pharmacokinetics and the impact on pulmonary and systemic hemodynamics [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
The study is to investigate the safety, tolerability, pharmacokinetics and the impact on pulmonary and systemic hemodynamics of single doses of orally administered BAY 60-4552 in a single dose escalation design. [ Time Frame: 72 hours ]
Complete list of historical versions of study NCT00565565 on ClinicalTrials.gov Archive Site
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Single Dose Escalation Study in Patients With Chronic Heart Failure
Proof of Concept Study to Investigate Safety, Tolerability, Pharmacokinetics and the Impact on Pulmonary and Systemic Hemodynamics of a Single Oral Dose of BAY60-4552 in Patients With Biventricular Chronic Heart Failure and Pulmonary Hypertension in a Non-randomized, Non-blinded, Dose Escalation Design.

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Heart Failure
Drug: BAY60-4552
Single dose escalation starting with 1 mg
Experimental: Arm 1
Intervention: Drug: BAY60-4552
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00565565
12356, 2007-003216-54
No
Head Clinical Pharmacology, Bayer HealthCare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP