Placebo Controlled, Randomized, Double-Blind, Multi-Center Study to Investigate the Efficacy and Tolerability of BAY 58-2667 - Tabular View

Tracking Information

First Received Date ^ICMJE

November 15, 2007

Last Updated Date

June 9, 2009

Start Date ^ICMJE

December 2007

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary efficacy outcome measure will be the change of pulmonary capillary wedge pressure (PCWP) from baseline to 8 hours versus placebo. [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The primary efficacy outcome measure will be the change of pulmonary capillary wedge pressure (PCWP) from baseline to 8 hours versus placebo. [ Time Frame: 8 hours ]

Change History

Complete list of historical versions of study NCT00559650 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality of Life [ Time Frame: Up to 30 days Follow-up ] [ Designated as safety issue: No ]
Rehospitalization [ Time Frame: Up to 30 days Follow-up ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Quality of Life [ Time Frame: Upto 30 days Follow-up ]
Rehospitalization [ Time Frame: upto 30 days Follow-up ]

Descriptive Information

Brief Title ^ICMJE

Placebo Controlled, Randomized, Double-Blind, Multi-Center Study to Investigate the Efficacy and Tolerability of BAY 58-2667

Official Title ^ICMJE

Placebo Controlled, Randomized, Double-Blind, Multi-Center, Multinational Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 Given Intravenously in Patients With Decompensated Chronic Congestive Heart Failure

Brief Summary

The purpose of this study is to assess a dose titration scheme, of a new drug (BAY 58-2667) given intravenously, to evaluate if this is safe and can help to improve the well-being, symptoms (e.g. breathing) and outcome of decompensated heart failure. Patients living with chronic heart failure have a risk of increased number of hospitalisations because of worsening of their condition (decompensated heart failure). The current treatment of acute heart failure consists of oxygen and medical treatment with vasodilators and positive inotropic agents (drugs, which should strengthen the pump function of the heart) which have their limitations. Therefore there is a need for new drugs in treatment of acute heat failure.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Congestive Heart Failure

Intervention ^ICMJE

Drug: Placebo
Drug: BAY 58-2667

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

149

Completion Date

March 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with decompensated chronic congestive heart failure, NYHA functional class III-IV, either ischemic or non-ischemic, requiring hospitalization, and with clinical indication for parenteral pharmacotherapy and invasive hemodynamic monitoring (i.e indwelling Swan-Ganz pulmonary artery catheter) and PCWP >/= 18 mmHg.
Patients must have the clinical diagnosis of CHF made at least 3 month prior to enrollment.
Male or female patients, age 18 years or more.

Exclusion Criteria:

Females of child-bearing potential.
Acute de-novo heart failure.
Acute myocardial infarction and/or myocardial infarction within 30 days.
Valvular heart disease requiring surgical intervention during the course of the study.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Croatia, Czech Republic, Estonia, Germany, Hungary, Israel, Italy, Lithuania, Poland, Russian Federation, Serbia, Slovenia, Spain, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00559650

Responsible Party

Therapeutic Area Head, Bayer HealthCare AG

Study ID Numbers ^ICMJE

12480, EudraCT Nr: 2007-003059-36

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

June 2009

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