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    Summary
    EudraCT Number:2007-004271-19
    Sponsor's Protocol Code Number:RLX.CHF.003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-02
    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 ConcernedItaly - Italian Medicines Agency
    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
    A.3.2Name or abbreviated title of the trial where available
    RELAX
    A.4.1Sponsor's protocol code numberRLX.CHF.003
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorBAS Medical Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 rhR1x
    D.3.4Pharmaceutical form Solution for 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 µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 typeNon Applicabile
    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 placeboSolution for 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), hypertension and mild to moderate renal impairment
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10007554
    E.1.2Term Cardiac 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 overall objectives of this study are to test the ability of relaxin to improve symptoms (dyspnea and signs of heart failure) and renal function in patients hospitalized with acute heart failure (AHF), hypertension and mild to moderate renal impairment; to evaluate the safety of relaxin in these patients; and to evaluate the ability of relaxin to reduce long term mortality/morbidity in these patients
    E.2.2Secondary objectives of the trial
    The secondary efficacy endpoints are: Proportion of patients with renal impairment defined as a &#8805; 25% increase in serum creatinine from baseline to Day 5 Time from study drug initiation to death or rehospitalization for HF or renal dysfunction through Day 60 in the combined RELAX-AHF-1 and -2 studies
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to provide written informed consent 2. Male or female &#8805; 18 years of age, with body weight <115 kg 3. Systolic blood pressure > 125 mmHg at the time of screening 4. Hospitalized for AHF. AHF is defined as including all of the following at screening: a. Dyspnea at rest or with minimal exertion b. Pulmonary congestion as evidenced by interstitial edema on chest radiograph c. BNP &#8805; 350pg/mL or NT-pro-BNP &#8805;1400 pg/mL measured at any time between presentation (including the emergency department [ED]) and screening 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 screening for the study 7. Impaired renal function defined as a creatinine clearance on admission between 30-75 mL/min, 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 theresults 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 >38C (oral or equivalent) or sepsis or active infection requiring IV antimicrobial 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 (intraaortic 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. Diabetic nephropathy with proteinuria +2 or greater by dipstick 7. Significant pulmonary disease (history of oral daily steroid dependency, history of dependency on bronchodilators or need for intubation in the past for acute exacerbation,or currently receiving IV steroids) 8. Significant stenotic valvular disease (severe aortic stenosis [AVA < 1.0 or peak gradient > 50 on prior or current echocardiogram], or severe mitral regurgitation, severe aortic regurgitation, or severe mitral stenosis) 9. Any organ transplant recipient, or patient currently listed for transplant or admitted for any transplantation 10. Major surgery within 30 days 11. Hematocrit < 25% or blood transfusion in the prior 14 days or active, life-threatening GI bleeding 12. Major neurologic event, including cerebrovascular events, in the prior 60 days 13. Clinical diagnosis of acute coronary syndrome within 45 days prior to screening(including the present admission) as determined by both clinical and enzymatic criteria 14. Troponin > 3 times the upper limit of normal between presentation and screening. 15. AHF due to significant arrhythmias (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) 16. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function) 17. Known hepatic impairment (as evidenced by total bilirubin > 3 mg/dL, albumin < 2.8 mg/dL, or increased ammonia levels if performed) 18. Non-cardiac pulmonary edema, including suspected sepsis 19. 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 20. Inability to follow instructions or comply with follow-up procedures
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with marked or moderate improvement in subject-reported dyspnea score using the Likert 7-point scale at both 12 and 24 hours following the start of study drug infusion in the absence of worsening heart failure symptoms and signs between 3 and 24 hours following the start of study drug infusion.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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
    Fase II/III
    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.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    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 No
    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
    I pazienti saranno seguiti per un minimo di 60 giorni o per un massimo di 180 dall'amministrazione della prima dose del farmaco in studio
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-07-02. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 900
    F.4.2.2In the whole clinical trial 2330
    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 Decision2008-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-08
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