Acute Heart FailurePhase 2COMPOSE 2NCT01067859
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)
A Phase 2 study testing Cinaciguat (BAY58-2667) in people with Acute Heart Failure, run by Bayer at 30 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Cinaciguat (BAY58-2667)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 30 sitesin 9 countries
- Study dates
- Mar 2010to Nov 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
30 sites in 9 countries.
30 sites in 9 countries
United States6 sites
Study site
Birmingham, Alabama, 35294
Study site
Boston, Massachusetts, 02114
Study site
Cincinnati, Ohio, 45267-0542
Study site
Columbus, Ohio, 43210
Study site
Jacksonville, Florida, 32209
Study site
Philadelphia, Pennsylvania, 19141
Argentina5 sites
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, 1078
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1039AAO
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1181ACH
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1428DCO
Study site
Quilmes, Buenos Aires
Germany5 sites
Study site
Bad Krozingen, Baden-Wurttemberg, 79189
Study site
Bad Nauheim, Hesse, 61231
Study site
Bad Oeynhausen, North Rhine-Westphalia, 32545
Study site
Berlin, State of Berlin, 12559
Study site
Düsseldorf, North Rhine-Westphalia, 40225
Mexico4 sites
Study site
Guadalajara, Jalisco, 44280
Study site
Guadalajara, Jalisco, 44670
Study site
Mexico City, Mexico City, 57000
Study site
México D.F.
Belgium3 sites
Study site
Aalst, 9300
Study site
Bruxelles - Brussel, 1070
Study site
Leuven, 3000
France3 sites
Study site
Créteil, 94010
Study site
Paris, 75475
Study site
Toulouse, 31403
About this study
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)
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.
- Conditions
- Acute Heart Failure
- Being tested
- Cinaciguat (BAY58-2667), Placebo
- Keywords
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinaciguat (BAY58-2667)Drug
Infusion of 25 µg/h during 48 hours
Cinaciguat (BAY58-2667)Drug
Infusion of 10 µg/h during 48 hours
PlaceboDrug
Infusion of placebo during 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Cinaciguat (BAY58-2667) |
| Arm 2 | Experimental | Not described Receives: Drug: Cinaciguat (BAY58-2667) |
| Arm 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Capillary Wedge Pressure
Measured: 8 hours
Secondary outcomes (3)
Cardiac index (CI)
Measured: 8 hours and 48 hours
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Measured: Follow up (after 30+5 days)
Right atrial pressure (RAP)
Measured: 8 hours and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067859
- Sponsor's protocol ID
- 14663
- Other IDs
- 2009-014378-16, 2009
- Acronym
- COMPOSE 2
- Status last verified
- Nov 2014
- First submitted
- 11 Feb 2010
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01067859
- Acronym / sponsor ID
- COMPOSE 2 / 14663
- Conditions
- Acute Heart Failure
- Keywords
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Cinaciguat (BAY58-2667) |
| Arm 2 | Experimental | Drug: Cinaciguat (BAY58-2667) |
| Arm 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cinaciguat (BAY58-2667)Infusion of 25 µg/h during 48 hours | Drug | Arm 1 |
| Cinaciguat (BAY58-2667)Infusion of 10 µg/h during 48 hours | Drug | Arm 2 |
| PlaceboInfusion of placebo during 48 hours | Drug | Arm 3 |
Primary outcome
Pulmonary Capillary Wedge Pressure
Time frame: 8 hours
3 secondary outcomes
Cardiac index (CI)
Time frame: 8 hours and 48 hours
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Follow up (after 30+5 days)
Right atrial pressure (RAP)
Time frame: 8 hours and 48 hours
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
30 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cinaciguat (BAY58-2667) in people with Acute Heart Failure, run by Bayer at 30 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Argentina, Germany, Mexico, Belgium and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Capillary Wedge Pressure (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.