Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.

    The EU Clinical Trials Register currently displays   37738   clinical trials with a EudraCT protocol, of which   6184   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2007-003059-36
    Sponsor's Protocol Code Number:Bay 58-2667/12480
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-10-29
    Trial results View results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedLithuania - SMCA
    A.2EudraCT number2007-003059-36
    A.3Full title of the trial
    Placebo controlled, randomized, double-blind, multi-center, multinational Phase IIb study to investigate the efficacy and tolerability of BAY 58-2667 given intravenously in patients with acute decompensated chronic congestive heart failure
    A.4.1Sponsor's protocol code numberBay 58-2667/12480
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBayer Healthcare AG
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBAY 58-2667
    D.3.2Product code BAY 58-2667
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcinaciguat
    D.3.9.1CAS number 329773-35-5
    D.3.9.2Current sponsor codeBAY 58-2667
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.005
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboIntravenous infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with acute decompensated chronic congested heart failure
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064653
    E.1.2Term Acute decompensated heart failure
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective of the study is to investigate the safety and efficacy of a titration phase (8 hours) and a maintenance phase (maximum 40 hours) of intravenous BAY 58-2667 in patients with acute decompensated chronic congestive heart failure with the need for parenteral pharmacotherapy and invasive haemodynamic monitoring (i.e. indwelling Swan-Ganz pulmonary artery catheter) and PCWP ≥ 18mmHg.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The following inclusion criteria must be met:

    • Patients with acute decompensated chronic congestive heart failure, NYHA functional class III-IV, either ischemic or non-ischemic, requiring hospitalization, and with clinical indication for parenteral pharmacotherapy and invasive hemodynamic monitoring (i.e indwelling Swan-Ganz pulmonary artery catheter) and PCWP ≥ 18 mmgHg.

    • Patients must have the clinical diagnosis of CHF made at least 3 month prior to enrollment.

    • Male or female patients, aged 18 years or more. Female patients should be postmenopausal for at least one year.

    • Patients must experience worsening of at least one of the symptoms below leading to hospitalization at the time of entry into the study:
    Dyspnea Symptoms such as:
    Dyspnea (labored or difficult breathing) at rest,
    Dyspnea (labored or difficult breathing) on minimal exertion
    Orthopnea (difficult breathing except in the upright position),
    Nocturnal dyspnea (awaken from sleep due to respiratory distress).
    Clinical evidence of volume overload such as:
    peripheral edema,
    hepatic congestion with ascites,
    pulmonary congestion/rales, or pleural effusion (chest X-ray)
    jugular venous distension.

    • Left ventricular ejection fraction < 40 % within the last 6 months.

    • Ability to understand and willing to sign informed consent form.
    E.4Principal exclusion criteria
    The following factors determined during the run-in period will automatically exclude the subject from participating in the trial:
    • Females of child-bearing potential.
    • 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, e.g. acute myocarditis.
    • Unstable angina requiring angiography
    • Cardiogenic shock
    • Patients requiring any of the following: : nitrates,( e.g. nitroprusside, nitroglycerin); vasodilators (e.g. nesiritide), any intravenous positive inotropic drug (e.g. levosimendan) or vasoconstrictive agents (e.g. catecholamines) within the last 3 hours (dobutamine up to 4 µg/kg/minute is allowed).
    • Need for endotracheal intubation and mechanical ventilation.
    • Patients with cardiac arrest or patients with history of cardiac arrest within 3 months, unless precipitated by an event such as an acute myocardial infarction, induction by catheter placement, severe transient electrolyte abnormality, an electrophysiology procedure, or addressed by automatic implantable cardioverter defibrillator placement.
    • Patients with increased risk of cardiac arrest (e.g. AV Block °III, QTc > 450 msec for men and QTc > 470 msec for women if patient is in sinus rhythm and there is no conduction delay in the ECG influencing the QT-interval.)
    • Ventricular fibrillation within 30 days (> 15 seconds long)
    • Patients showing during ECG monitoring uncontrolled ventricular rhythm disorder.
    • Uncontrolled atrial fibrillation or flutter or any supraventricular tachycardia.
    • Cardiac surgery within the last month (such as cardiac revascularization surgery, valvular surgery, biventricular resynchronization procedure, ventricular reduction surgery or cardiac myoplasty, implantation of mechanical ventricular assist device).
    • Systolic blood pressure < 100 mmHg or > 180 mmHg.
    • Heart rate ≥ 120 BPM
    • Pulmonary embolism within the last 30 days prior to enrollment.
    • PDE 5 inhibitor use within the last 48 hours.
    • Strong CYP2C8 (inhibitors like gemfibrozil(stop at least 24 hours before study drug infusion)
    • Heart failure secondary to pulmonary disease and patients with primary pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.
    • History of or clinically significant evidence of any severe disease other than heart failure that preclude participation.
    • Known significant liver disease (e.g. acute clinical hepatitis, chronic active hepatitis, cirrhosis).
    • Calculated creatinine clearance < 30 mL/min. using MDRD or Cockroft Gault equation
    • BMI < 20 kg/m2 (BMI equal to 20 is accepted)
    • Drug- or alcohol abuse.
    • Concomitant participation in another trial or study.
    • Therapy with another investigational product within 30 days prior start of study
    • Any other condition or therapy, which in the opinion of the Principal Investigator would make the patient unsuitable for this study and presumably will not allow participation for the full planned study period.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome measure will be the change of pulmonary capillary wedge pressure (PCWP) from baseline to 8 hours versus placebo.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Information not present in EudraCT
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 210
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice