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    Summary
    EudraCT Number:2009-014378-16
    Sponsor's Protocol Code Number:Bay 58-2667/14663
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-12-22
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2009-014378-16
    A.3Full title of the trial
    A Placebo Controlled, Randomized, Double-Blind, Fixed-dose, Multicenter, Phase IIb Study to Investigate the Efficacy and Tolerability of Low Dose BAY 58-2667 (25 μg/h, 10 μg/h) Given Intravenously to Subjects with Acute Decompensated Chronic Congestive Heart Failure (ADHF)
    A.4.1Sponsor's protocol code numberBay 58-2667/14663
    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.1.3.4CountryGermany
    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.4.2Country
    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 % (W/V) percent weight/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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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
    Acute Decompensated Chronic Congestive Heart Failure (ADHF)
    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
    The primary objective of this study is to investigate the safety and efficacy of a fixed dose (10 µg/h or 25 µg/h) over at least 24 hours and up to 48 hours of intravenous BAY 58-2667 in subjects with acute decompensated chronic congestive heart failure needing parenteral pharmacotherapy and invasive hemodynamic monitoring (ie, indwelling pulmonary artery catheter [Swan-Ganz]) and pulmonary capillary wedge pressure (PCWP) ≥ 20 mmHg with CI ≤ 2.5. The primary endpoint will be to evaluate the PCWP reduction at eight hours.
    E.2.2Secondary objectives of the trial
    to evaluate the potential effects of three fixed doses of BAY 58-2667 (10 μg/h and 25 μg/h ) and placebo given intravenously on QT/QTc prolongation. An extended ECG/QT monitoring will be performed in this study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • 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 hysterectomy
    or
    Males and non-pregnant, non-lactating females, 18 years of age or older. For females of child-bearing potential, one of the following medically acceptable contraceptive methods must be used or they agree to abstain from heterosexual intercourse while participating in the study. One or more of these methods should be used during the study and continue for 30 days after completion of the study (i.e., the follow-up visit) :
    - Double-barrier methods of contraception (eg, condoms plus spermicidal foam)
    - Intrauterine contraceptive device
    - Approved pharmaceutical contraceptive product (eg, birth control pills or patches, long-term injectable or implantable hormonal contraceptive)
    • Subjects with ADHF, NYHA functional class III-IV, requiring hospitalization, and with clinical indication for parenteral pharmacotherapy and invasive hemodynamic monitoring (ie, in-dwelling pulmonary artery catheter [Swan-Ganz]) and PCWP ≥ 20 mmHg with CI ≤ 2.5 at run-in and baseline Note: PCWP and CI must be re-checked at baseline, immediately before starting study drug infusion, to ensure that this criterion is still met
    • Subjects must have the clinical diagnosis of CHF, either ischemic or non-ischemic, made at least three months prior to enrollment and a history of heart failure hospitalization or IV diuretic treatment required within the last 12 months
    • Subjects must experience worsening of both of the symptoms listed below leading to hospitalization at the time of hospital admission up to study run-in. Worsening of these symptoms does not need to be displayed at baseline.
    - Dyspnea Symptoms:
    > Dyspnea (labored or difficult breathing) at rest or
    > Dyspnea (labored or difficult breathing) on minimal exertion or
    > Orthopnea (difficult breathing except in the upright position) or
    > Nocturnal dyspnea (awaken from sleep due to respiratory distress)
    And
    - Clinical evidence of volume overload:
    > Peripheral edema or
    > Hepatic congestion with ascites or
    > Rales or pulmonary congestion or
    > Jugular venous distension
    • Left ventricular ejection fraction ≤40 % measured by any modality (echocardiography, nuclear testing, cardiac magnetic resonance imaging [MRI], ventricular angiography) in the patient’s medical history without intervening revascularization or cardiac surgery in the meantime
    • Systolic blood pressure ≥ 120 mm Hg and heart rate < 100 beats per minute [shock index (heart rate/systolic blood pressure) < 1] at run-in and baseline. Note: blood pressure and heart rate must be re-checked at baseline, immediately before starting study drug infusion, to ensure that this criterion is still met.
    • Ability to understand and willing to sign informed consent form
    E.4Principal exclusion criteria
    • Systolic blood pressure > 180 mm Hg at run-in or baseline. Note: blood pressure must be re-checked at baseline, immediately before starting study drug infusion, to ensure that this criterion is still met.
    • Acute de-novo heart failure
    • Acute myocardial infarction and/or myocardial infarction within the last 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
    • Cardiogenic shock
    • Subjects requiring any of the following medication: any intravenous vasodilating drug (eg, nitrates, nitroprusside) or any intravenous natriuretic peptide (eg, nesiritide, carperitide) within the last 3 hours prior to dosing with study medication, or any catecholamine or levosimendan within the last 30 days prior to dosing with study medication
    • Need for endotracheal intubation and mechanical ventilation
    • Subjects with cardiac arrest or subjects with history of cardiac arrest within three 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 or pacemaker
    • Subjects with increased risk of cardiac arrest (eg, QTc > 450 msec in males and QTc > 470 msec in females, atrial ventricular block II or III)
    • Ventricular fibrillation within the last 30 days (duration > 15 seconds), unless precipitated by a transient event or addressed by an implantable cardioverter defibrillator (ICD)
    • Subjects showing during ECG monitoring sustained or unsustained ventricular tachycardia, either monomorphic or polymorphic (unless precipitated by an event such as catheter placement)
    • Uncontrolled atrial fibrillation or flutter or any supraventricular tachycardia with a ventricular rate more than 100 bpm for more than 30 minutes
    • Cardiac surgery within the last 30 days (such as cardiac revascularization surgery, valvular surgery, biventricular resynchronization procedure, ventricular reduction surgery or cardiac myoplasty, implantation of mechanical ventricular assist device)
    • Implantation of a device (such as hemodynamic transcutaneous device, pacemaker, cardiac resynchronization therapy, or implantable cardioverter defibrillator within 30 days prior to enrollment
    • Pulmonary embolism within the last 30 days prior to enrollment
    • PDE 3 or PDE-5 inhibitor use within the last 48 hours prior to onset of study drug infusion
    • Strong CYP2C8 inhibitors like gemfibrozil or montelukast (must have already been stopped at least 24 hours before study drug infusion)
    • Heart failure secondary to pulmonary disease and subjects 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
    • Clinical relevant hepatic dysfunction (eg, induced by acute clinical hepatitis, chronic active hepatitis, cirrhosis) indicated by one of the following :
    - bilirubin > 2 times upper limit normal and alanine aminotransferase (ALT) > 3 times upper limit normal
    OR
    - signs of severe hepatic insufficiency (eg, impaired albumin synthesis with albumin < 35g/l, hepatic encephalopathy > Stage 1 [according to West Haven Criteria of Altered Mental Status In Hepatic Encephalopathy)
    • Body mass index (BMI ) ≤ 20 kg/m2
    • eGFR <30 mL/min using MDRD (Modification of Diet Renal Disease)
    • Ongoing 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 would make the subject 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)
    Change of pulmonary capillary wedge pressure (PCWP) from baseline to eight hours.
    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 No
    E.7.1.3.1Other 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 Yes
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days15
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 60
    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 Decision2010-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-03-01
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