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BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF) (COMPOSE 1)

Primary Purpose

Acute Heart Failure

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cinaciguat (BAY58-2667)
Cinaciguat (BAY58-2667)
Cinaciguat (BAY58-2667)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Heart Failure focused on measuring Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and non-pregnant, non-lactating female subjects, age >/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy
  • Subjects must have the clinical diagnosis of CHF made at least three months prior to enrollment

  • Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study:

    • dyspnea and
    • clinical evidence of volume overload

Exclusion Criteria:

  • 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
  • Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
  • Primary hypertrophic cardiomyopathy
  • Acute inflammatory heart disease, eg, acute myocarditis
  • Unstable angina requiring angiography

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

Outcomes

Primary Outcome Measures

Pulmonary Capillary Wedge Pressure

Secondary Outcome Measures

Cardiac index (CI)
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Right atrial pressure (RAP)

Full Information

First Posted
February 8, 2010
Last Updated
September 23, 2015
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01065077
Brief Title
BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
Acronym
COMPOSE 1
Official Title
A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY58-2667 (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
Keywords
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Arm Title
Arm 4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cinaciguat (BAY58-2667)
Intervention Description
Infusion of 150 µg/h during 48h
Intervention Type
Drug
Intervention Name(s)
Cinaciguat (BAY58-2667)
Intervention Description
Infusion of 100 µg/h during 48h
Intervention Type
Drug
Intervention Name(s)
Cinaciguat (BAY58-2667)
Intervention Description
Infusion of 50 µg/h during 48h
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Infusion of placebo during 48h
Primary Outcome Measure Information:
Title
Pulmonary Capillary Wedge Pressure
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Cardiac index (CI)
Time Frame
8 hours and 48 hours
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame
Follow up (30 + 5 days)
Title
Right atrial pressure (RAP)
Time Frame
8 hours and 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and non-pregnant, non-lactating female subjects, age >/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy Subjects must have the clinical diagnosis of CHF made at least three months prior to enrollment Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study: dyspnea and clinical evidence of volume overload Exclusion Criteria: 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 Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease Primary hypertrophic cardiomyopathy Acute inflammatory heart disease, eg, acute myocarditis Unstable angina requiring angiography
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4010
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
City
Oulu
ZIP/Postal Code
90220
Country
Finland
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17475
Country
Germany
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50924
Country
Germany
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66424
Country
Germany
City
Erfurt
State/Province
Thüringen
ZIP/Postal Code
99089
Country
Germany
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07740
Country
Germany
City
Haifa
ZIP/Postal Code
34362
Country
Israel
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
City
Tiberias
ZIP/Postal Code
31905
Country
Israel
City
San Fermo della Battaglia
State/Province
Como
ZIP/Postal Code
22020
Country
Italy
City
Brescia
ZIP/Postal Code
25100
Country
Italy
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
City
Mantova
ZIP/Postal Code
46100
Country
Italy
City
Torino
ZIP/Postal Code
10126
Country
Italy
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
City
Kure
State/Province
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
City
Higashiibaraki
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
City
Omura
State/Province
Nagasaki
ZIP/Postal Code
856-8562
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
City
Osaka
ZIP/Postal Code
543-0035
Country
Japan
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
City
Zgorzelec
ZIP/Postal Code
59-900
Country
Poland
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
City
Cluj-Napoca
ZIP/Postal Code
400001
Country
Romania
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
City
Moscow
ZIP/Postal Code
109263
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115093
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119881
Country
Russian Federation
City
Beograd
ZIP/Postal Code
11000
Country
Serbia
City
Nis
ZIP/Postal Code
18000
Country
Serbia
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
City
Lucenec
ZIP/Postal Code
984 39
Country
Slovakia
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
City
Celje
ZIP/Postal Code
3000
Country
Slovenia
City
Golnik
ZIP/Postal Code
4204
Country
Slovenia
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
City
Lugano
State/Province
Ticino
ZIP/Postal Code
6900
Country
Switzerland
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
22713287
Citation
Gheorghiade M, Greene SJ, Filippatos G, Erdmann E, Ferrari R, Levy PD, Maggioni A, Nowack C, Mebazaa A; COMPOSE Investigators and Coordinators. Cinaciguat, a soluble guanylate cyclase activator: results from the randomized, controlled, phase IIb COMPOSE programme in acute heart failure syndromes. Eur J Heart Fail. 2012 Sep;14(9):1056-66. doi: 10.1093/eurjhf/hfs093. Epub 2012 Jun 19.
Results Reference
result
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

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