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
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)
2 other identifiers
interventional
5
9 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2010
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2010
CompletedFirst Posted
Study publicly available on registry
February 12, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedOctober 8, 2015
November 1, 2014
6 months
February 11, 2010
September 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pulmonary Capillary Wedge Pressure
8 hours
Secondary Outcomes (3)
Cardiac index (CI)
8 hours and 48 hours
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Follow up (after 30+5 days)
Right atrial pressure (RAP)
8 hours and 48 hours
Study Arms (3)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALArm 3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (30)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Jacksonville, Florida, 32209, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Cincinnati, Ohio, 45267-0542, United States
Unknown Facility
Columbus, Ohio, 43210, United States
Unknown Facility
Philadelphia, Pennsylvania, 19141, United States
Unknown Facility
Quilmes, Buenos Aires, Argentina
Unknown Facility
Buenos Aires, Ciudad Auton. de Buenos Aires, 1078, Argentina
Unknown Facility
Buenos Aires, Ciudad Auton. de Buenos Aires, C1039AAO, Argentina
Unknown Facility
Buenos Aires, Ciudad Auton. de Buenos Aires, C1181ACH, Argentina
Unknown Facility
Buenos Aires, Ciudad Auton. de Buenos Aires, C1428DCO, Argentina
Unknown Facility
Graz, Styria, 8020, Austria
Unknown Facility
Innsbruck, Tyrol, 6020, Austria
Unknown Facility
Aalst, 9300, Belgium
Unknown Facility
Bruxelles - Brussel, 1070, Belgium
Unknown Facility
Leuven, 3000, Belgium
Unknown Facility
Créteil, 94010, France
Unknown Facility
Paris, 75475, France
Unknown Facility
Toulouse, 31403, France
Unknown Facility
Bad Krozingen, Baden-Wurttemberg, 79189, Germany
Unknown Facility
Bad Nauheim, Hesse, 61231, Germany
Unknown Facility
Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
Unknown Facility
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Unknown Facility
Berlin, State of Berlin, 12559, Germany
Unknown Facility
Dublin, DUBLIN 9, Ireland
Unknown Facility
Guadalajara, Jalisco, 44280, Mexico
Unknown Facility
Guadalajara, Jalisco, 44670, Mexico
Unknown Facility
Mexico City, Mexico City, 57000, Mexico
Unknown Facility
México D.F., Mexico
Unknown Facility
Quezon City, 1102, Philippines
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2010
First Posted
February 12, 2010
Study Start
March 1, 2010
Primary Completion
September 1, 2010
Study Completion
November 1, 2010
Last Updated
October 8, 2015
Record last verified: 2014-11