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    The EU Clinical Trials Register currently displays   43618   clinical trials with a EudraCT protocol, of which   7209   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).

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    EudraCT Number:2012-003219-77
    Sponsor's Protocol Code Number:2012-003219-77
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-12-20
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2012-003219-77
    A.3Full title of the trial
    Effects on Exercise Hemodynamics of Vasopressin Blockade by Conivaptan Infusion in Heart Failure
    Infusion af conivaptan hos patienter med kronisk stabilt hjertesvigt under arbejde
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects on Exercise Hemodynamics of Vasopressin Blockade by Conivaptan Infusion in Heart Failure Patients
    Infusion af conivaptan hos patienter med kronisk stabilt hjertesvigt under arbejde
    A.4.1Sponsor's protocol code number2012-003219-77
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCopenhagen University Hospital, Rigshospitalet
    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 supportCopenhagen University Hospital
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCopenhagen University Hospital, Rigshospitalet
    B.5.2Functional name of contact pointFinn Gustafsson
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.4Telephone number004535459743
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D. name Vaprisol
    D. of the Marketing Authorisation holderAstellas Pharma
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameVaprisol
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboInfusion
    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
    Heart Failure
    E.1.1.1Medical condition in easily understood language
    Decreased function of the heart (heart failure)
    Nedsat pumpefunktion af hjertet (hjertesvigt)
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10019279
    E.1.2Term Heart failure
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test if infusion of the V1A/V2-receptor blocker conivaptan improves hemodynamics and physical capacity in HF patients on optimal HF medical therapy and to improve understanding of the role of vasopressin in HF.
    At undersøge om infusion af V1A/V2-receptor blokkeren conivaptan medfører en forbedring af hæmodynamikken og arbejdskapaciteten hos hjertesvigtpatienter i optimal medicinsk behandling samt at forbedre forståelsen af vasopressinsystemet ved hjertesvigt.
    E.2.2Secondary objectives of the trial
    Not applicable
    Ikke anført
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age > 18 years
    -LVEF < 45 %
    -Treatment with beta-blockers and ACE-inhibitors for at least 1 month
    -NYHA-class II-III
    -Given informed consent

    Women, who have not yet entered menopause (defined as no menstrual bleeding in the last 12 months), will provide a negative urine HCG before entering the study
    -Alder > 18 år
    -Kendt LVEF < 45 %
    -Kendt hjertesvigtbehandling med beta-blokker og ACE-hæmmer i minimum 1 måned
    -NYHA-klasse II-III
    -Underskrevet informeret samtykke

    Kvinder der endnu ikke er indtrådt i menopause (defineret som udeblivende menstruation i minimum 1 år) skal aflevere negativ urin HCG inden indtrædelse i studiet.
    E.4Principal exclusion criteria
    -Signs of symptomatic or ongoing myocardial ischemia
    -Presence of hypovolemic hyponatremia (as judged by the investigator)
    -Clinical signs of volume depletion or dehydration
    -Hypernatremia (P-Na+) > 145 mmol/L
    -Chronic obstructive pulmonary disease (FEV1 < 1L)
    -Supine systolic blood pressure < 85 mmHg
    -Significant orthostatic hypotension
    -standing blood pressure < 80 mmHg or a blood pressure drop > 20 mmHg when changing from a supine to a standing position
    -Uncontrolled hypertension
    -Uncontrolled cardiac arrhythmias
    -Untreated serious hypothyroidism
    -Adrenal insufficiency
    -Poor echocardiographic window
    -Not able to perform exercise testing
    -Permanent atrial fibrillation or atrial fluttering
    -Planned coronary by-pass surgery
    -Moderate hepatic impairment (ALAT/ASAT > 3 UNL)
    -Presence of other diseases affecting treatment with conivaptan or the evaluation of safety
    -Severely decreased kidney function (eGFR < 20 ml/min)
    -Serum K+< 3.5 or > 5.5 mmol/L
    -Conivaptan intolerability
    -Corn allergy
    -Treatment with potent CYP3A-inhibitors (ketoconazole, otrakonazole, clarithromycin, ritonavir, indinavir)
    -Treatment with arginine vasopressin, oxytocin, desmopressin and other medications for the treatment of hyponatremia (lithium salts, urea and demeocycline)
    -Warfarin treatment
    -Presence of infection or active bleeding
    -Need of inotropic circulatory support within the last 30 days
    -Pregnant women or fertile women not taking safe contraception
    -Women who are breastfeeding
    -Hemodynamically significant heart valve disease estimated by echocardiography
    -The ability to understand written and oral Danish
    -Contraindication to insertion of Swan-Ganz catheter
    -Tegn til pågående symptomatisk eller asymptomatisk myokardie iskæmi
    -Tilstedeværelse af hypovolæmisk hyponatriæmi vurderet ved investigator (kliniske tegn til volumendepletion eller dehydrering)
    -Hypernatriæmi (P-Na+) > 145 mmol/L
    -Kronisk obstruktiv lungesygdom (FEV1 < 1 L)
    -Liggende systolisk blodtryk < 85 mmHg
    -Betydende ortostatisk hypotension
    -Stående systolisk blodtryk < 80 mmHg eller et blodtryksfald > 20 mmHg ved overgang fra liggende til stående stilling
    -Ukontrolleret hypertension
    -Ukontrollerede arytmier
    -Ubehandlet alvorlig hypothyroidisme
    -Binyrebark insufficiens
    -Ringe ekkokardiografisk indblik
    -Kan ikke gennemføre arbejdstest
    -Permanent atrieflimren/flagren
    -Planlagt koronar bypass operation
    -Betydende leverpåvirkning (ALAT/ASAT > x 3 ULN)
    -Tilstedeværelse af anden sygdom, der kan påvirke behandling med conivaptan eller evaluering af safety
    -Svært nedsat nyrefunktion (eGFR < 20 mL/min)
    -Serum kalium < 3.5 eller > 5.5 mM/L
    -Kendt overfølsomhed for conivaptan
    -Kendt allergi overfor majs (korn) produkter
    -Behandling med potente CYP3A inhibitorer (ketokonazol, itrakonazol, clarithromycin, ritonavir og indinavir)
    -Behandling med arginin vasopressin, oxytocin, desmopressin og andre medikamenter til behandling af hyponatriæmi (lithiumsalte, urea og demeocyclin)
    -Behandling med marevan
    -Aktiv infektion eller blødning
    -Behov for inotropisk kredsløbsstøtte inden for de sidste 30 dage
    -Gravide eller kvinder i den fertile alder der ikke tager sikker kontraception.
    -Ammende kvinder
    -Hæmodynamisk betydende hjerteklapsygdom vurderet ved ekkokardiografi
    -Skal kunne tale og forstå skriftligt og mundtligt dansk
    -Kontraindikationer mod anlæggelse af Swan-Ganz kateter
    E.5 End points
    E.5.1Primary end point(s)
    -PCWP at the submaximal exercise intensity of 50 % of the maximal exercise capacity
    -PCWP ved submaksimalt arbejde ved 50 % af den maksimale arbejdsintensitet
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 day
    1 dag
    E.5.2Secondary end point(s)
    -Cardiac index (CI) during submaximal exercise before and during conivaptan-infusion
    -Pulmonary and peripheral vascular resistance during exercise
    -Left ventricular end diastolic diameter during exercise
    -The Doppler-index of the left ventricular filling (E/e’) during exercise
    -The change in BNP, MR-ANP and copeptin from rest to submaximal exercise
    -Cardiac index (CI) under submaksimalt arbejde før og under infusion af conivaptan
    -Pulmonal og vaskulær modstand under arbejde
    -Venstre ventrikel slutdiastolisk diameter under arbejde
    -Dopplerindex af venstre ventrikels fyldning (E/e´) under arbejde
    -Ændring BNP, MR-ANP og copeptin fra hvile til submaksimalt arbejde
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 day
    1 dag
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Last visit of the last subject
    Sidste forsøgspersons sidste besøg
    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 months
    E.8.9.1In the Member State concerned days
    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.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 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 state20
    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)
    Patients will be contacted by telephone one week after the study has been ended
    Patienter vil blive kontaktet telefonisk en uge efter endt studie
    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 Decision2012-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-26
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