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    Summary
    EudraCT Number:2006-002403-13
    Sponsor's Protocol Code Number:Ularitide-1502
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2006-11-03
    Trial 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 number2006-002403-13
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blinded, Placebo-controlled Study of Ularitide in the Treatment of Subjects with Acute Decompensated Heart Failure
    A.4.1Sponsor's protocol code numberUlaritide-1502
    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 SponsorPDL BioPharma 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 nameUlaritide
    D.3.4Pharmaceutical form Powder for 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.3.8INN - Proposed INNularitide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboPowder for solution 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
    Acute decompensated heart failure
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    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
    To compare the efficacy and safety of ularitide with placebo in subjects hospitalized for symptomatic ADHF.
    E.2.2Secondary objectives of the trial
    To characterize the pharmacokinetic (limited to steady-state concentration [Css] and clearance [CL]) and immunogenicity profiles of ularitide versus placebo in subjects hospitalized for symptomatic ADHF. To assess a subject’s change in quality of life throughout dosing and during follow up compared with baseline.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Males and females ≥ 18 years.
    2) Unplanned hospitalization for ADHF.
    3)Randomization within 24 hours after presentation to emergency department or hospital for ADHF.
    4) Dyspnea at rest as assessed by the subject. Subject must have the ability to interpret and report self-assessed dyspnea
    5) At least 1 of the following 2 criteria:
    •Prior medical history of CHF (eg, prior hospitalization for CHF) or left ventricular ejection fraction <40%, as determined by appropriate imaging techniques, such as echocardiography, nuclear scintigraphy, or contrast left ventriculography in the past 12 months.
    •Clinical evidence (at screening) of heart failure, including abnormal jugular venous pressure (JVP) (eg, >8 cm above the clavicle, assessed at 45°angle), rales or crackles more than a third above bases, or 2+ lower extremity edema.
    6) Radiographic evidence (at screening) of pulmonary congestion (eg, redistribution, alveolar or interstitial edema, or pleural effusions).
    7) On optimal background therapy for ADHF (as determined by the investigator); subjects are required to have received, at a minimum, at least one hour of oxygen supplementation and at least one dose of IV furosemide at a minimum dose of 40 mg (or another diuretic at a comparable dose; eg, 2 mg bumetanide or 20 mg torsemide), with the last bolus being delivered >2 hours before study drug administration is initiated.
    8) If subject received IV opiate, the last dose should have been >3 hours before administration of study drug.
    9) If the subject is a woman of potential childbearing age, documentation of a negative urine pregnancy test result within 24 hours prior to randomization.
    10) Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).
    E.4Principal exclusion criteria
    1) Breathing rate <18 breaths per minute (measured during 60 seconds).
    2) A systolic blood pressure (SBP) less than or equal to 110 mmHg or >200 mmHg within an hour before randomization, or SBP <120 mmHg for subjects receiving intravenous (IV) inotropics or vasodilators. A SBP <90 mmHg any time before randomization. (Subjects on baseline IV inotropes or vasodilators must be on a stable dose for ≥3 hours prior to randomization.)
    3) Brain natriuretic peptide (BNP) <400 pg/mL or NT pro-BNP <1200 pg/mL, anytime from initial presentation to hospital to randomization.
    4) Active ongoing myocardial ischemia, hospitalization for acute myocardial infarction, or administration of thrombolytic therapy in the last 30 days.
    5) Any cardiogenic shock (SBP <90 mmHg with signs or symptoms of organ hypoperfusion) from initial presentation to randomization.
    6) Body temperature ≥ 38ºC.
    7) Acute unstable clinical condition such as a hemodynamically significant arrhythmia or a persistent heart rate ≥130 bpm or is refractory to treatment (at the time of screening), or any unstable heart failure syndrome requiring any mechanical-assist device or emergency surgery.
    8) Acute decompensated heart failure associated with endocrine, metabolic, or drug-related toxicity.
    9) Percutaneous coronary intervention, coronary artery bypass graft surgery, other cardiac surgery, or major noncardiac surgery within 90 days prior to randomization.
    10) Any volume depletion or severe electrolyte imbalance.
    11) Anemia (hemoglobin <10 mg/dL or hematocrit <30%).
    12) Significant acute or chronic respiratory disorder (eg, severe chronic obstructive pulmonary disease) or primary pulmonary hypertension with baseline dyspnea that may interfere with the ability to interpret dyspnea assessments or hemodynamic measurements.
    13) For subjects with concomitant invasive hemodynamic monitoring (ie, pulmonary artery catheter monitoring): Baseline PCWP of ≤ 20 mmHg.
    E.5 End points
    E.5.1Primary end point(s)
    A statistically significant improvement in the mean scores of subject-assessed dyspnea, as measured by the 7 point Likert scale, and SGA, as measured by the 7 point Likert scale, at 6 hours from initiation of study drug infusion for the ularitide group compared with the placebo group. Additionally, a trend towards improvement in dyspnea at 3 hours and SGA at 3 and 48 hours from initiation of study drug infusion for the ularitide group compared with the placebo group will also be assessed.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 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) 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA152
    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 years2
    E.8.9.1In the Member State concerned months5
    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 months5
    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 2006-11-03. Yes
    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 Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1250
    F.4.2.2In the whole clinical trial 3000
    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 Decision2006-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-22
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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