Back to resultsA Phase IIb Study to Investigate the Efficacy and Tolerability of Lower Doses Cinaciguat (25 µg/h, 10 µg/h) Given Intravenously to Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF) (COMPOSE 2)
Primary Purpose
Acute Heart Failure
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cinaciguat (BAY58-2667)
Cinaciguat (BAY58-2667)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Heart Failure focused on measuring Heart Failure
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 Congestive Heart Failure (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 Type
Experimental
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
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
1. Study Identification
Unique Protocol Identification Number
NCT01067859
Brief Title
A Phase IIb Study to Investigate the Efficacy and Tolerability of Lower Doses Cinaciguat (25 µg/h, 10 µg/h) Given Intravenously to Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
Acronym
COMPOSE 2
Official Title
A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of Low Dose BAY58-2667 (25 µg/h, 10 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
September 2010 (Actual)
Study Completion Date
November 2010 (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
5 (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
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Cinaciguat (BAY58-2667)
Intervention Description
Infusion of 25 µg/h during 48 hours
Intervention Type
Drug
Intervention Name(s)
Cinaciguat (BAY58-2667)
Intervention Description
Infusion of 10 µg/h during 48 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Infusion of placebo during 48 hours
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 (after 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 Congestive Heart Failure (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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0542
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
City
Quilmes
State/Province
Buenos Aires
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
1078
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1039AAO
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1428DCO
Country
Argentina
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8020
Country
Austria
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1070
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Creteil
ZIP/Postal Code
94010
Country
France
City
PARIS cedex 10
ZIP/Postal Code
75475
Country
France
City
Toulouse
ZIP/Postal Code
31403
Country
France
City
Bad Krozingen
State/Province
Baden-Württemberg
ZIP/Postal Code
79189
Country
Germany
City
Bad Nauheim
State/Province
Hessen
ZIP/Postal Code
61231
Country
Germany
City
Bad Oeynhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32545
Country
Germany
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
City
Berlin
ZIP/Postal Code
12559
Country
Germany
City
Dublin
ZIP/Postal Code
DUBLIN 9
Country
Ireland
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
City
Mexico D.F.
State/Province
México
ZIP/Postal Code
57000
Country
Mexico
City
México D.F.
Country
Mexico
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
12. IPD Sharing Statement
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
A Phase IIb Study to Investigate the Efficacy and Tolerability of Lower Doses Cinaciguat (25 µg/h, 10 µg/h) Given Intravenously to Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
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