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

Sponsor:	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

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Locations

United States, California

San Diego, California, United States, 92103-8765
United States, District of Columbia

Washington, District of Columbia, United States, 20010-2975
United States, Massachusetts

Boston, Massachusetts, United States, 02114-2696
United States, Ohio

Cincinnati, Ohio, United States, 45267-0564

Fairfield, Ohio, United States, 45014
United States, Texas

Dallas, Texas, United States, 75216-7167
Canada

Quebec, Canada, G1V 4G5
Canada, Nova Scotia

Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario

Toronto, Ontario, Canada, M5C 2T2
Croatia

Zagreb, Croatia, 10000

Split, Croatia, 21000
Czech Republic

Brno, Czech Republic, 62500

Plzen, Czech Republic, 30599

Brno, Czech Republic, 656 91

Hradec Kralove, Czech Republic, 500 05

Praha 2, Czech Republic, 12808
Estonia

Tallin, Estonia, 13419

Tartu, Estonia, 51014
Germany

Berlin, Germany, 12200
Germany, Baden-Württemberg

Heidelberg, Baden-Württemberg, Germany, 69120
Germany, Bayern

Würzburg, Bayern, Germany, 97080
Germany, Hessen

Bad Nauheim, Hessen, Germany, 61231
Germany, Mecklenburg-Vorpommern

Greifswald, Mecklenburg-Vorpommern, Germany, 17489
Germany, Nordrhein-Westfalen

Köln, Nordrhein-Westfalen, Germany, 50931

Bonn, Nordrhein-Westfalen, Germany, 53105

Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
Germany, Saarland

Homburg, Saarland, Germany, 66421
Germany, Sachsen-Anhalt

Halle, Sachsen-Anhalt, Germany, 06097
Germany, Thüringen

Jena, Thüringen, Germany, 07740

Erfurt, Thüringen, Germany, 99089
Hungary

Budapest, Hungary, H-1096

Debrecen, Hungary, 4032

Vac, Hungary, 2600

Zalaegerszeg, Hungary, 8900
Israel

Safed, Israel, 13100

Haifa, Israel, 34362

Tel Hashomer, Israel, 52621

Jerusalem, Israel, 91120
Italy

Pavia, Italy, 27100

Perugia, Italy, 06156

Milano, Italy, 20162

Bologna, Italy, 40138

Bergamo, Italy, 24128

Ferrara, Italy, 44100
Lithuania

Vilnius, Lithuania, 08661

Kaunas, Lithuania, 50009
Poland

Zabrze, Poland, 41-800

Szczecin, Poland, 70-111

Krakow, Poland, 31-202

Wroclaw, Poland, 50-981

Gdansk, Poland, 80-952
Russian Federation

Moscow, Russian Federation, 119048

Moscow, Russian Federation, 109263

Moscow, Russian Federation, 129090

Moscow, Russian Federation, 115093
Serbia

Beograd, Serbia, 11000

Sremska Kamenica, Serbia, 21204
Slovenia

Ljubljana, Slovenia, 1000

Golnik, Slovenia, 4202

Murska Sobota, Slovenia, 9000

Celje, Slovenia, 3000
Spain

Barcelona, Spain, 08036

Girona, Spain, 17007
Spain, A Coruña

Santiago de Compostela, A Coruña, Spain, 15706
Spain, Barcelona

Sabadell, Barcelona, Spain, 08208
Spain, Madrid

Majadahonda, Madrid, Spain, 28222
Sweden

Uppsala, Sweden, 751 85

Göteborg, Sweden, 413 45
United Kingdom, Derbyshire

Chesterfield, Derbyshire, United Kingdom, S44 5BL
United Kingdom, Greater London

Harrow, Greater London, United Kingdom, HA1 3UJ
United Kingdom, Hertfordshire

Barnet, Hertfordshire, United Kingdom, EN5 3DJ

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

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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

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 27, 2009