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)

September 23, 2015 updated by: Bayer

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Cinaciguat (BAY58-2667)
Infusion of 150 µg/h during 48h.
Drug: Cinaciguat (BAY58-2667)
Infusion of 100 µg/h during 48h
Drug: Cinaciguat (BAY58-2667)
Infusion of 50 µg/h during 48h
Experimental: Arm 2
Drug: Cinaciguat (BAY58-2667)
Infusion of 150 µg/h during 48h.
Drug: Cinaciguat (BAY58-2667)
Infusion of 100 µg/h during 48h
Drug: Cinaciguat (BAY58-2667)
Infusion of 50 µg/h during 48h
Experimental: Arm 3
Drug: Cinaciguat (BAY58-2667)
Infusion of 150 µg/h during 48h.
Drug: Cinaciguat (BAY58-2667)
Infusion of 100 µg/h during 48h
Drug: Cinaciguat (BAY58-2667)
Infusion of 50 µg/h during 48h
Placebo Comparator: Arm 4
Drug: Placebo
Infusion during 48h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dyspnea VAS (using a visual analogue scale)
Time Frame: 8 hours
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea assessment (Likert Scale)
Time Frame: up to follow-up (30 - 35 days)
up to follow-up (30 - 35 days)
Overall health status assessment (EQ-5D)
Time Frame: up to follow-up (30 - 35 days)
up to follow-up (30 - 35 days)
Changes in the dyspnea VAS at other time points
Time Frame: Up to follow up visit
Up to follow up visit
Dyspnea assessment through Likert scale
Time Frame: Up to follow up visit
Up to follow up visit
Overall health status assessment through EQ-5D Health Questionnaire
Time Frame: Up to the follow-up visit
Up to the follow-up visit
Global clinical assessment by the physician
Time Frame: At 8, 24, and 48 hours
At 8, 24, and 48 hours
Change in concomitant medications
Time Frame: During the treatment
During the treatment
Safety variables
Time Frame: Up to end of study
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
Up to end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

February 4, 2010

First Submitted That Met QC Criteria

February 5, 2010

First Posted (Estimate)

February 8, 2010

Study Record Updates

Last Update Posted (Estimate)

October 8, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14836 (NSD, Norway)
  • 2009-017082-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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