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    Summary
    EudraCT Number:2007-004271-19
    Sponsor's Protocol Code Number:RLX.CHF.003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-29
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2007-004271-19
    A.3Full title of the trial
    A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure.

    Estudio de fase II/III, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de relaxina en sujetos con insuficiencia cardíaca aguda
    A.3.2Name or abbreviated title of the trial where available
    RELAX-AHF
    A.4.1Sponsor's protocol code numberRLX.CHF.003
    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 SponsorCorthera, Inc.
    B.1.3.4CountryUnited States
    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 nameRelaxin
    D.3.2Product code rhRlx
    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.3.9.3Other descriptive nameRelaxin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant human relaxin (rhRlx)
    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 hospitalized with Acute Heart Failure (AHF), normal to elevated blood pressure, and mild to moderate renal impairment. Pacientes hospitalizados con insuficiencia cardíaca aguda (ICA), presión arterial normal o elevada y disfunción renal leve o moderada
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10000803
    E.1.2Term Acute 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 Pre-RELAX-AHF Phase II pilot portion of the study has been completed. This

    amendment focuses on the RELAX-AHF main Phase III portion of the study.



    RELAX-AHF Main Phase:

    The objectives of this phase of the study are to confirm the efficacy of IV relaxin, in addition to

    standard therapy, in improving symptoms of heart failure, dyspnea, and in preventing

    intermediate term re-admission for HF or renal failure and cardiovascular death in subjects

    hospitalized for AHF
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to provide written informed consent

    2. Male or female ? 18 years of age, with body weight <160 kg

    3. Systolic blood pressure > 125 mmHg at the start of screening and at the end of screening

    4. Hospitalized for AHF. AHF is defined as including all of the following measured at any

    time between presentation (including the emergency department [ED]) and the end of

    screening:

    a. Dyspnea at rest or with minimal exertion

    b. Pulmonary congestion on chest radiograph

    c. BNP ? 350pg/mL or NT-pro-BNP ?1400 pg/mL

    5. Able to be randomized within 16 hours from presentation to the hospital, including the ED

    6. Received IV furosemide of at least 40 mg (or equivalent) at any time between admission

    to emergency services (either ambulance or hospital, including the ED) and the start of

    screening for the study

    7. Impaired renal function defined as an estimated glomerular filtration rate (eGFR) on

    admission between 30-75 mL/min/1.73 m2, calculated using the simplified Modification

    of Diet in Renal Disease (sMDRD) equation
    E.4Principal exclusion criteria
    1. Pregnant or breast-feeding women (women of child bearing potential must have the

    results of a negative pregnancy test recorded prior to study drug administration)

    2. Administration of intravenous radiographic contrast agent within 72 hours prior to

    screening or acute contrast-induced nephropathy at the time of screening

    3. Temperature >38°C (oral or equivalent) or sepsis or active infection requiring IV anti-

    microbial treatment

    4. Current (within 2 hours prior to screening) or planned (through the completion of study

    drug infusion) treatment with any IV therapies, including vasodilators (including

    nesiritide), positive inotropic agents and vasopressors, or mechanical support (intra-aortic

    balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist

    device), with the exception of IV nitrates at a dose of < 0.1 mg/kg/hr if the patient has a

    systolic BP > 150 mmHg at screening

    5. Current or planned ultrafiltration, hemofiltration, or dialysis

    6. Known significant pulmonary disease

    7. Known significant valvular disease (including any of the following: severe aortic stenosis

    [AVA < 1.0 or peak gradient > 50 on prior or current echocardiogram], severe aortic

    regurgitation, or severe mitral stenosis)

    8. Any organ transplant recipient, or patient currently listed for transplant or admitted for

    any transplantation

    9. Major surgery within 30 days

    10. Hematocrit < 25% or blood transfusion in the prior 14 days or active, life-threatening GI

    bleeding

    11. Major neurologic event, including cerebrovascular events, in the prior 60 days

    12. Clinical diagnosis of acute coronary syndrome within 45 days prior to screening

    (including the present admission) as determined by both clinical and enzymatic criteria

    13. Troponin > 3 times the upper limit of normal (including "borderline/intermediate")

    between presentation and screening.

    14. AHF due to significant arrhythmias (including any of the following: ventricular

    tachycardia, bradyarrhythmias with ventricular rate <45 beats per minute or any second

    or third degree AV block or atrial fibrillation/flutter with ventricular response of >120

    beats per minute)

    15. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive

    cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler

    echocardiographic assessments of diastolic function)

    16. Known hepatic impairment

    17. Non-cardiac pulmonary edema, including suspected sepsis

    18. Administration of an investigational drug or implantation of investigational device, or

    participation in another trial, within 30 days before screening or previous treatment with

    relaxin

    19. Inability to follow instructions or comply with follow-up procedures
    E.5 End points
    E.5.1Primary end point(s)
    The two primary efficacy endpoints for the Phase III RELAX-AHF are:



    1)Area Under the Curve (AUC) representing the change in patient-reported dyspnea from

    baseline measured by a 100-mm Visual Analog Scale (VAS) from baseline through Day 5

    2) Moderately or markedly better patient-reported dyspnea relative to the start of study drug

    on the 7-point Likert scale at 6, 12 and 24 hours (at all 3 timepoints)
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA117
    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
    Patients will be followed a minimum of 60 days and up to a maximum of 180 days from start of first study drug dose.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 880
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The treatment of care will be what is expected normally for this type of condition.
    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 Decision2009-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-14
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