Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43392   clinical trials with a EudraCT protocol, of which   7179   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools

    < Back to search results

    Print Download

    EudraCT Number:2011-006208-11
    Sponsor's Protocol Code Number:1544?H?254
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-02-28
    Trial results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-006208-11
    A.3Full title of the trial
    A randomized, controlled multicenter clinical trial comparing endoscopic band ligation versus oral carvedilol in the primary
    prophylaxis of esophageal variceal bleeding in patients with cirrosis
    Ensayo clínico multicéntrico, aleatorizado y controlado que compara la ligadura endoscópica con banda con el carvedilol oral en la profilaxis primaria de la hemorragia de varices esofágicas en pacientes con cirrosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study comparing the use of a medical procedure (endoscopic band ligation) versus a drug treatment (carvedilol) to prevent bleeding of esophageal varices in patients with liver disease.
    Estudio que compara el uso de un procedimiento médico (ligadura endoscópica) frente a medicamento (carvedilol) para evitar el sangrado de várices esofágicas en pacientes con enfermedad del hígado.
    A.4.1Sponsor's protocol code number1544?H?254
    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 SponsorCAIBER
    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 supportMINISTERIO DE SANIDAD Y POLITICA SOCIAL
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCAIBER
    B.5.2Functional name of contact pointUCICEC ALBACETE
    B.5.3 Address:
    B.5.3.2Town/ cityALBACETE
    B.5.3.3Post code02008
    B.5.4Telephone number34967597375
    B.5.5Fax number3493227 98 77
    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 Yes
    D. name Carvedilol ratiopharm 6,25 mg comprimidos recubiertos con película EFG
    D. of the Marketing Authorisation holderRatiopharm España, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameCarvedilol ratiopharm 6,25 mg comprimidos recubiertos con película EFG
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 72956-09-3
    D.3.9.3Other descriptive nameCARVEDILOL
    D.3.9.4EV Substance CodeSUB06153MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Esophageal variceal bleeding in patients with cirrhosis
    Hemorragia de várices esofáficas en pacientes con cirrosis
    E.1.1.1Medical condition in easily understood language
    Bleeding of varices of Esophagus in patients with hepatic disease
    Sangrado de várices de esófago en pacientes con enfermedad hepática
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether carvedilol improves bleeding free survival in patients with cirrhosis and medium or large esophageal varices when compared with endoscopic band ligation.
    Evaluar si el carvedilol mejora la supervivencia libre de sangrado en pacientes con cirrosis y varices esofágicas medianas o grandes, en comparación con la ligadura endoscópica con banda.
    E.2.2Secondary objectives of the trial
    1. To evaluate whether carvedilol, as compared to endoscopic band ligation,
    a) improves survival
    b) decreases the incidence of variceal bleeding and of bleeding from non-variceal sources
    c) decreases the development of other complications of portal hypertension (ascites, spontaneous bacterial peritonitis, bacterial infections, hepatorrenal syndrome, and hepatic encephalopathy).
    2. To compare the incidence of portal vein thrombosis between both treatment arms.
    3. To compare the rate of adverse events.
    4. To compare the costs of both treatments.
    1. Evaluar si el carvedilol, en comparación con la ligadura endoscópica con banda:
    a) mejora la supervivencia
    b) disminuye la incidencia de hemorragia por varices y de hemorragias de origen no varicoso
    c) disminuye el desarrollo de otras complicaciones de la hipertensión portal (ascitis, peritonitis bacteriana espontánea, infecciones bacterianas, síndrome hepatorrenal y encefalopatía hepática).
    2. Comparar la incidencia de trombosis venosa portal entre ambos brazos de tratamiento.
    3. Comparar la tasa de eventos adversos.
    4. Comparar costes de ambos tratamientos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Age from 18 to 80 years.
    ? Liver cirrhosis diagnosed by liver biopsy or unequivocal clinical, analytical or radiologic criteria
    ? Presence of esophageal varices or gastroesophageal varices type GOV1, medium or large in size (>5 mm)
    ? Ability to understand study procedures and to comply with them for the entire length of the study.
    ? Edad entre 18 y 80 años.
    ? Cirrosis hepática diagnosticada por biopsia hepática o por criterios clínicos, analíticos o radiológicos inequívocos.
    ? Presencia de varices esofágicas o gastroesofágicas tipo GOV1, medianas o grandes (> 5 mm)
    ? Capacidad para entender los procedimientos del estudio y para cumplir con ellos durante toda la duración del mismo.
    E.4Principal exclusion criteria
    ? Previous esophageal variceal bleeding.
    ? Pregnant or lactating patients
    ? Known hypersensibility to carvedilol
    ? Contraindications to carvedilol.
    ? Patients already taking beta-blockers
    ? Previous endoscopic band ligation or endoscopic injection sclerotherapy
    ? Total portal vein thrombosis or portal vein cavernoma
    ? Hepatocellular carcinoma out of Milano criteria
    ? End-stage liver disease as indicated by a Child-Pugh score over 13.
    ? Extrahepatic malignancy that significantly affects survival
    ? Previous TIPS or porto-caval shunt
    ? Sangrado previo de várices esofágicas.
    ? Pacientes embarazadas o en período de lactancia.
    ? Hipersensibilidad conocida a carvedilol
    ? Contraindicaciones para el carvedilol.
    ? Pacientes que ya toman beta-bloqueantes.
    ? Previa ligadura endoscópica con banda o escleroterapia por inyección endoscópica.
    ? Trombosis venosa portal total o cavernoma de la vena porta
    ? Carcinoma hepatocelular que no cumple los criterios de Milano.
    ? Enfermedad hepática terminal (puntuación Child-Pugh > 13).
    ? Tumor maligno extrahepático que afecta significativamente a la supervivencia
    ? TIPS o derivación porto-cava previa.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first variceal bleeding or death.
    Tiempo hasta el primer sangrado de várices o muerte.
    E.5.1.1Timepoint(s) of evaluation of this end point
    In every follow up visit (V1-V7)
    En todas las visitas de seguimiento (V1-V7)
    E.5.2Secondary end point(s)
    1.Time to variceal bleeding.
    2. Time to death.
    3. Time to death or liver transplantation.
    4. Incidence of clinical decompensation (development of ascites, spontaneous bacterial peritonitis, bacterial infections, hepatorenal syndrome or hepatic encephalopathy).
    5. Incidence of portal vein thrombosis, assessed by abdominal Doppler-ultrasound.
    6. Proportion of patients with adverse events.
    7. Proportion of patients with severe adverse events.
    8. Costs of the Management of the patients.
    1. Tiempo hasta el sangrado de várices.
    2. Tiempo hasta la muerte.
    3. Tiempo hasta la muerte o el trasplante hepático.
    4. Incidencia de descompensación clínica (desarrollo de ascitis, peritonitis bacteriana espontánea, infecciones bacterianas, síndrome hepatorrenal o encefalopatía hepática).
    5. Incidencia de trombosis de la vena porta, evaluada por Doppler abdominal.
    6. Proporción de pacientes con acontecimientos adversos.
    7. Proporción de pacientes con acontecimientos adversos graves.
    8. Costes del manejo de los pacientes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. In every follow up visit (V1-V7)
    2. In every follow up visit (V1-V7)
    3. In every follow up visit (V1-V7)
    4. In every follow up visit (V1-V7)
    5. V2-V7
    6. V0-V7
    7. V0-V7
    8. In every follow up visit (V1-V7)
    1. En todas las visitas de seguimiento (V1-V7)
    2. En todas las visitas de seguimiento (V1-V7)
    3. En todas las visitas de seguimiento (V1-V7)
    4. En todas las visitas de seguimiento (V1-V7)
    5. V2-V7
    6. V0-V7
    7. V0-V7
    8. En todas las visitas de seguimiento (V1-V7)
    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 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 No
    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. 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E. description
    Ligadura endoscópica por banda
    Endoscopic band ligation
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 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: 290
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state390
    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)
    After completion of the study, patients will continue the treatment and
    the follow up visits as recomended by the rutine clinical practice.
    Tras la finalización del estudio los pacientes continuarán con el
    tratamiento y seguimiento correspondientes a la práctica clínica
    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 Decision2012-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands