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

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00559650

Purpose

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.

Condition	Intervention	Phase
Congestive Heart Failure	Drug: Placebo Drug: BAY 58-2667	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	149
Study Start Date:	December 2007
Study Completion Date:	March 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Placebo Comparator	Drug: Placebo Will be standard therapy and placebo versus, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours
Arm 2: Experimental	Drug: BAY 58-2667 Will be standard therapy and BAY 58-2667, Uptitration from 100-600µg/g, intravenous, over maximum 48 hours

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559650

Show 71 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	12480, EudraCT Nr: 2007-003059-36
Study First Received:	November 15, 2007
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00559650 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Acute decompensated heart failure
Double blind study,
BAY 58-2667
Soluble guanylate cyclase activator

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 02, 2009