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) (COMPOSE 2)

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 Low Dose BAY58-2667 (25 µg/h, 10 µg/h) Given Intravenously to Subjects With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

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)

5

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

  • Argentina
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina
    • Ciudad Auton. de Buenos Aires
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1039AAO
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1181ACH
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, 1078
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1428DCO
  • Austria
    • Steiermark
      • Graz, Steiermark, Austria, 8020
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
  • Belgium
      • Aalst, Belgium, 9300
      • Bruxelles - Brussel, Belgium, 1070
      • Leuven, Belgium, 3000
  • France
      • Creteil, France, 94010
      • PARIS cedex 10, France, 75475
      • Toulouse, France, 31403
  • Germany
      • Berlin, Germany, 12559
    • Baden-Württemberg
      • Bad Krozingen, Baden-Württemberg, Germany, 79189
    • Hessen
      • Bad Nauheim, Hessen, Germany, 61231
    • Nordrhein-Westfalen
      • Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
  • Ireland
      • Dublin, Ireland, DUBLIN 9
  • Mexico
      • México D.F., Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
      • Guadalajara, Jalisco, Mexico, 44670
    • México
      • Mexico D.F., México, Mexico, 57000
  • Philippines
      • Quezon City, Philippines, 1102
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • Florida
      • Jacksonville, Florida, United States, 32209
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0542
      • Columbus, Ohio, United States, 43210
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141

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 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

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Drug: Cinaciguat (BAY58-2667)
Infusion of 25 µg/h during 48 hours
Drug: Cinaciguat (BAY58-2667)
Infusion of 10 µg/h during 48 hours
PLACEBO_COMPARATOR: Arm 3
Drug: Placebo
Infusion of placebo during 48 hours
EXPERIMENTAL: Arm 2
Drug: Cinaciguat (BAY58-2667)
Infusion of 25 µg/h during 48 hours
Drug: Cinaciguat (BAY58-2667)
Infusion of 10 µg/h during 48 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulmonary Capillary Wedge Pressure
Time Frame: 8 hours
8 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiac index (CI)
Time Frame: 8 hours and 48 hours
8 hours and 48 hours
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: Follow up (after 30+5 days)
Follow up (after 30+5 days)
Right atrial pressure (RAP)
Time Frame: 8 hours and 48 hours
8 hours and 48 hours

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

March 1, 2010

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

February 11, 2010

First Submitted That Met QC Criteria

February 11, 2010

First Posted (ESTIMATE)

February 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 8, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14663
  • 2009-014378-16 (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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