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A Phase IIb Study to Investigate the Efficacy and Tolerability of Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF) (COMPOSE EARLY)

Primary Purpose

Heart Failure, Heart Decompensation

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 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 ovarectomy, 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 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

Outcomes

Primary Outcome Measures

Dyspnea VAS (using a visual analogue scale)

Secondary Outcome Measures

Dyspnea assessment (Likert Scale)
Overall health status assessment (EQ-5D)
Changes in the dyspnea VAS at other time points
Dyspnea assessment through Likert scale
Overall health status assessment through EQ-5D Health Questionnaire
Global clinical assessment by the physician
Change in concomitant medications
Safety variables
Frequency of TEAEs (AEs were considered to be treatment emergent if they started after the start of sthe study drug infusion to up to 2 calendar days after the end of the study drug infusion); treatment-emergent serious adverse events (SAEs); deaths; evaluation of renal and cardiac function; Change in heart rate; Change in systolic and diastolic blood pressure; Laboratory parameters (including parameters related to hematology, clinical chemistry, urinalysis, and biomarkers); ECG assessment

Full Information

First Posted
February 4, 2010
Last Updated
September 23, 2015
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01064037
Brief Title
A Phase IIb Study to Investigate the Efficacy and Tolerability of Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)
Acronym
COMPOSE EARLY
Official Title
A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of BAY 58-2667 (50 µg/h, 100 µg/h, 150 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF) Within 12 Hours After Hospital Admission (Pulmonary Artery Catheter eg, Swan-Ganz Not Required)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 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
Heart Failure, Heart Decompensation
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
62 (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 during 48h
Primary Outcome Measure Information:
Title
Dyspnea VAS (using a visual analogue scale)
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Dyspnea assessment (Likert Scale)
Time Frame
up to follow-up (30 - 35 days)
Title
Overall health status assessment (EQ-5D)
Time Frame
up to follow-up (30 - 35 days)
Title
Changes in the dyspnea VAS at other time points
Time Frame
Up to follow up visit
Title
Dyspnea assessment through Likert scale
Time Frame
Up to follow up visit
Title
Overall health status assessment through EQ-5D Health Questionnaire
Time Frame
Up to the follow-up visit
Title
Global clinical assessment by the physician
Time Frame
At 8, 24, and 48 hours
Title
Change in concomitant medications
Time Frame
During the treatment
Title
Safety variables
Description
Frequency of TEAEs (AEs were considered to be treatment emergent if they started after the start of sthe study drug infusion to up to 2 calendar days after the end of the study drug infusion); treatment-emergent serious adverse events (SAEs); deaths; evaluation of renal and cardiac function; Change in heart rate; Change in systolic and diastolic blood pressure; Laboratory parameters (including parameters related to hematology, clinical chemistry, urinalysis, and biomarkers); ECG assessment
Time Frame
Up to end of study

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 ovarectomy, 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
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-7240
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
City
Pardubice
ZIP/Postal Code
532 03
Country
Czech Republic
City
Praha 10
ZIP/Postal Code
10034
Country
Czech Republic
City
Praha 5
ZIP/Postal Code
15006
Country
Czech Republic
City
Praha 5
ZIP/Postal Code
15030
Country
Czech Republic
City
Jyväskylä
Country
Finland
City
Turku
Country
Finland
City
Dommartin-les-toul
ZIP/Postal Code
54201
Country
France
City
Paris Cedex 04
ZIP/Postal Code
75181
Country
France
City
Paris cedex 13
ZIP/Postal Code
75013
Country
France
City
Paris
ZIP/Postal Code
75475
Country
France
City
POITIERS Cedex
ZIP/Postal Code
86021
Country
France
City
Nürnberg
State/Province
Bayern
ZIP/Postal Code
90471
Country
Germany
City
Melsungen
State/Province
Hessen
ZIP/Postal Code
34212
Country
Germany
City
Mönchengladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41063
Country
Germany
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
City
Erfurt
State/Province
Thüringen
ZIP/Postal Code
99089
Country
Germany
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
City
Budapest
ZIP/Postal Code
H-1096
Country
Hungary
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
City
Ballinasloe
State/Province
Co. Galway
Country
Ireland
City
Dublin
ZIP/Postal Code
8
Country
Ireland
City
Dublin
ZIP/Postal Code
DUBLIN 4
Country
Ireland
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Nahariya
Country
Israel
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
City
Safed
ZIP/Postal Code
13100
Country
Israel
City
Pontedecimo
State/Province
Genova
ZIP/Postal Code
16164
Country
Italy
City
Casarano
State/Province
Lecce
ZIP/Postal Code
73042
Country
Italy
City
Cotignola
State/Province
Ravenna
ZIP/Postal Code
48010
Country
Italy
City
Bari
ZIP/Postal Code
70124
Country
Italy
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Roma
ZIP/Postal Code
00161
Country
Italy
City
Roma
ZIP/Postal Code
00192
Country
Italy
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8650
Country
Japan
City
Chigasaki
State/Province
Kanagawa
ZIP/Postal Code
253-8558
Country
Japan
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
399-8701
Country
Japan
City
Sunto
State/Province
Shizuoka
ZIP/Postal Code
411-8611
Country
Japan
City
Tanabe
State/Province
Wakayama
ZIP/Postal Code
646-8558
Country
Japan
City
Kagoshima
ZIP/Postal Code
892-0853
Country
Japan
City
Shizuoka
ZIP/Postal Code
421-0193
Country
Japan
City
Seoul
State/Province
Jongno-gu,
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
City
Krakow
ZIP/Postal Code
31-121
Country
Poland
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
City
Szczecin
ZIP/Postal Code
70-965
Country
Poland
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1449
Country
South Africa
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2194
Country
South Africa
City
Kuils River
State/Province
Western Cape
ZIP/Postal Code
7580
Country
South Africa
City
Worcester
State/Province
Western Cape
ZIP/Postal Code
6850
Country
South Africa
City
Torrevieja
State/Province
Alicante
ZIP/Postal Code
03186
Country
Spain
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Harrow
State/Province
London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
City
Northampton
State/Province
Northamptonshire
ZIP/Postal Code
NN1 5BD
Country
United Kingdom

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 Cinaciguat (150 µg/h, 100 µg/h, 50 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

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