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   43861   clinical trials with a EudraCT protocol, of which   7284   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

    Summary
    EudraCT Number:2012-003332-23
    Sponsor's Protocol Code Number:B1261007
    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:2013-02-28
    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 number2012-003332-23
    A.3Full title of the trial
    A phase 2, randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate the efficacy and safety of once-daily administration of a chemokine CCR2/5 receptor antagonist (PF-04634817) in adults with Type 2 diabetes and overt nephropathy.
    ESTUDIO DE FASE II MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y DE GRUPOS PARALELOS, PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE LA ADMINISTRACIÓN UNA VEZ AL DÍA DE UN ANTAGONISTA DEL RECEPTOR DE QUIMIOCINAS CCR2/5 (PF-04634817) EN ADULTOS CON DIABETES TIPO 2 Y NEFROPATÍA EVIDENTE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2 multi-centre study to evaluate the efficacy and safety of a chemokine CCR2/5 receptor antagonist in adults with type 2 diabetes and overt nephropathy.
    Estudio de fase II multicéntrico para evaluar la eficacia y la seguridad de un antagonista del receptor de quimiocinas CCR2/5 en adultos con diabetes tipo 2 y nefropatía evidente.
    A.3.2Name or abbreviated title of the trial where available
    A phase 2 study of a chemokine CCR2/5 receptor antagonist in Type 2 diabetes with overt nephropathy
    A.4.1Sponsor's protocol code numberB1261007
    A.5.4Other Identifiers
    Name:IND/IDE numberNumber:107268
    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 SponsorPfizer Inc., 235 42nd Street, New York, NY 10017, USA
    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 supportPfizer Inc., 235 42nd Street, New York, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.5Fax number+13037391119
    B.5.6E-mailClinicalTrials.govCallCentre@pfizer.com
    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 namePF-04634817-24 Drug Product
    D.3.2Product code PF-04634817-24
    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.3.8INN - Proposed INNNone available
    D.3.9.2Current sponsor codePF-04634817-24
    D.3.9.4EV Substance CodePF-04634817-24
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic nephropathy
    Nefropatía diabética
    E.1.1.1Medical condition in easily understood language
    Diabetic nephropathy
    Nefropatía diabética
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10061835
    E.1.2Term Diabetic nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    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 the efficacy of PF-04634817 compared to placebo in the reduction of albuminuria following 12 weeks of treatment in subjects with type 2 diabetes and overt nephropathy.
    Evaluar la eficacia de PF-04634817 en comparación con placebo en la reducción de la albuminuria tras 12 semanas de tratamiento en pacientes con diabetes tipo 2 y nefropatía evidente.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of PF-04634817 following 12 weeks of treatment.

    To evaluate the effect of PF-04634817 on renal function.

    To evaluate the pharmacodynamic profile of PF-04634817 following 12 weeks of treatment.

    To evaluate the pharmacokinetics of PF-04634817 in subjects with type 2 diabetes and overt nephropathy.
    Evaluar la seguridad y la tolerabilidad de PF-04634817 tras 12 semanas de tratamiento.
    Evaluar el efecto de PF-04634817 en la función renal.
    Evaluar el perfil farmacodinámico de PF-04634817 tras 12 semanas de tratamiento.
    Evaluar la farmacocinética de PF-04634817 en pacientes con diabetes tipo 2 y nefropatía evidente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the
    study:
    1. Male or female subjects ?18 years.

    2. Female subjects who are of non-child bearing potential (ie, meet at least one of the following criteria):
    - Have medically confirmed ovarian failure OR
    - Are medically confirmed to be postmenopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause) OR
    - Have undergone hysterectomy or bilateral oophorectomy.

    3. Clinical diagnosis of type 2 diabetes together with stages 3a or 3b CKD, based on an eGFR of 30-59 mL/min/1.73m2.

    4. Evidence of persistent, overt albuminuria; defined as a UACR ?300 mg/g (?33.9 mg/mmol) or UPCR ?390 mg/g (44.1 mg/mmol), or equivalent, for 3 months or longer.

    5. Stable background therapy of RAAS inhibition (ie, an ACE inhibitor and/or an ARB, which may also include an aldosterone antagonist in double RAAS but not triple RAAS inhibitor therapy) for at least 3 months before screening and to be maintained for the duration of the study.

    6. Resting BP ?165/105 mm Hg. Subjects with resting BP >135/85 but ?165/105 must be being treated with at least one antihypertensive medication in addition to ACEi or ARB and have been on a stable dose(s) for at least 30 days.

    7. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

    8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures.
    Los pacientes deben cumplir todos los criterios de inclusión siguientes para poder participar en el estudio:
    1. Hombres o mujeres mayores de ?18 años.
    2. Mujeres sin capacidad para concebir (es decir, cumplen al menos uno de los siguientes criterios):
    - Se les ha confirmado médicamente insuficiencia ovárica o
    - Se ha confirmado médicamente que son posmenopáusicas (han cesado las menstruaciones regulares durante al menos 12 meses consecutivos sin ninguna causa alternativa patológica o psicológica) o
    - Se han sometido a histerectomía u ooforectomía bilateral.
    3. Diagnóstico clínico de diabetes tipo 2 junto con ERC en estadios 3a o 3b, basado en una TFGe de 30-59 ml/min/1,73 m2.
    4. Signos de albuminuria evidente y persistente; definida como un UACR de ?300 mg/g (?33,9 mg/mmol) o un UPCR ?390 mg/g (44,1 mg/mmol), o equivalente, durante 3 meses o más.
    5. Tratamiento estable de base de inhibición de RAAS (es decir, un IECA y/o un BRA, que también podría incluir un antagonista de aldosterona en doble tratamiento inhibidor de RAAS, pero no triple) durante al menos 3 meses antes de la selección y que deberá mantenerse durante todo el estudio.
    6. Tensión arterial en reposo de ?165/105 mm Hg. Los pacientes con una tensión arterial >135/85 pero ?165/105 deben estar tratándose con al menos una medicación antihipertensiva además de IECA o BRA y haber recibido una dosis estable durante al menos 30 días.
    7. Evidencia de un documento de consentimiento informado fechado y firmado personalmente que indique que el paciente ha sido informado de todos los aspectos pertinentes del estudio.
    8. Desea y es capaz de cumplir con las visitas programadas, el plan de tratamiento, los análisis de laboratorio y otros procedimientos del estudio.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.

    2. Subjects who are diagnosed with autosomal dominant polycystic kidney disease (ADPCKD), severe peripheral vascular disease (PVD) or obstructive uropathy.

    3. Subjects who have had a kidney transplant, or who require renal replacement therapy, or are expected to require such therapy within 6 months.

    4. Subjects who have a history of proteinuria >8.5 g/day.

    5. Subjects who have serum albumin <2.0 g/dL (<20 g/L).

    6. Subjects with poorly controlled diabetes mellitus, defined as HbA1C >10.5%.

    7. Subjects on direct renin inhibitor therapy (aliskiren, Tekturna/Rasilez or Valturna).

    8. Subjects receiving or likely to receive during the study any moderate-strong inhibitors or inducers of cytochrome P450 3A4 eg, itraconazole, erythromycin, ketoconazole, protease inhibitors, verapamil or diltiazem (Appendix 1).

    9. Known history of human immunodeficiency (HIV) based on documented history with positive serological test, or positive HIV serological test at screening. (Note: a documented negative HIV test within 12 months of screening is acceptable and does not need to be repeated).

    10. Significant allergy or known intolerance to CCR2 or CCR5 inhibitors or any ingredient in the formulations.

    11. History of congestive heart failure (NYHA class III or IV) or unstable angina, or a history of myocardial infarction, stroke or transient ischemic attack in the previous 6 months.

    12. Any relevant, clinically-significant abnormalities on physical examination or clinically significant laboratory tests, including subjects with moderate liver function tests abnormalities >1.5 times the upper limit of normal.

    13. Family history of prolonged QT syndrome, or who themselves have a QTc >450 msec, a QRS >120 msec, or any clinically significant ischemic changes as assessed by the investigator by 12-lead supine ECG at screening. The ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject?s eligibility. Preference is for QT to be corrected using Fridericia's correction, although Bazett's correction can also be used.

    14. Subjects currently experiencing any clinically significant or unstable medical condition that might limit their ability to complete the study, or to comply with the requirements of the protocol, including: dermatologic disease, hematological disease, pulmonary disease, hepatic disease, gastrointestinal disease, genitourinary disease, endocrine disease, neurological disease and psychiatric disease.

    15. Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin). A subject is considered cured if there has been no evidence of cancer recurrence in the previous 5 years.

    16. Blood donation in the previous 4 weeks, or stated intention to donate blood or blood products during the period of the study or within 1 month following completion of the study.

    17. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.

    18. Participation in other studies within the previous 60 days, or five times the plasma half-life (if known) of the investigational drug (whichever is longer) before the current study begins and/or during study participation.

    19. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

    20. Pregnant females; breastfeeding females; females of childbearing potential; males not using highly effective contraception or not agreeing to continue highly effective contraception for at least 28 days after last dose of investigational product.
    Los pacientes que presenten cualquiera de los siguientes aspectos no podrán ser incluidos en el estudio:
    1. Pacientes con ERC derivada de diabetes tipo 1 o ERC no diabética.
    2. Pacientes a los que se haya diagnosticado enfermedad poliquística renal autosómica dominante (ADPCKD), vasculopatía periférica grave o uropatía obstructiva.
    3. Pacientes que se han sometido a trasplante renal o que necesitan terapia de sustitución renal o se espera que necesiten este tipo de terapia en los próximos 6 meses.
    4. Pacientes con antecedentes de proteinuria >8,5 g/día.
    5. Pacientes con albúmina sérica <2,0 g/dl (<20 g/l).
    6. Pacientes con diabetes mellitus mal controlada, definida como HbA1C >10,5%.
    7. Pacientes en terapia directa con inhibidor de renina (aliskiren, Tekturna/Rasilez o Valturna).
    8. Los pacientes que reciben o probablemente reciban durante el estudio cualquier inhibidor o inductor de moderado a fuerte del citocromo P450 3A4 p. ej., itraconazol, eritromicina, ketoconazol, inhibidores de la proteasa, verapamilo o diltiazem (Apéndice 1)
    9. Antecedentes conocidos de inmunodeficiencia humana (VIH) según antecedentes documentados mediante una prueba serológica positiva o positivo para la prueba serológica de VIH en la selección. (Nota: un resultado negativo documentado en la prueba de VIH realizada en los 12 meses anteriores a la selección es adecuado y no necesita repetirse).
    10. Alergia significativa o intolerancia a los inhibidores de CCR2 o CCR5 o cualquier excipiente de las formulaciones.
    11. Antecedentes de insuficiencia cardíaca congestiva (NYHA clase III o IV) o angina inestable, o de infarto de miocardio, ictus o accidente isquémico transitorio en los 6 meses previos.
    12. Cualquier anomalía relevante y clínicamente significativa detectada en la exploración física o en los análisis de laboratorio, como pacientes con resultados anómalos >1,5 del límite superior de la normalidad en las pruebas de función hepática.
    13. Antecedentes familiares de síndrome del QT largo, o pacientes que tienen un QTc >450 ms, un QRS >120 ms, o cualquier cambio isquémico clínicamente significativo según la evaluación del investigador mediante ECG de 12 derivaciones en decúbito supino durante la selección. El ECG debe repetirse dos veces más y debe utilizarse la media de los tres valores de QTc o QRS para determinar la elegibilidad del paciente. El método preferido para corregir el QT es la corrección de Fridericia, aunque también puede usarse la de Bazett.
    14. Los pacientes que actualmente estén experimentando cualquier enfermedad clínicamente significativa o médica inestable que pueda limitar su capacidad para completar el estudio o para cumplir con los requisitos del protocolo como: enfermedad dermatológica, hemopatía, neumopatía, hepatopatía, enfermedad gastrointestinal, endocrinopatía, neuropatía y enfermedades psiquiátricas.
    15. Cualquier neoplasia maligna que no se considere curada (excepto carcinoma basocelular y carcinoma epidermoide de la piel). Se considera que un paciente está curado si no ha habido ningún signo de recidiva del cáncer en los 5 años previos.
    16. Donación de sangre las 4 semanas previas o intención expresa de donar sangre o hemoderivados durante el período del estudio o en 1 mes tras la finalización del estudio.
    17. Los pacientes que sean miembros del personal del centro de investigación, los parientes de los miembros del personal del centro o los pacientes que sean empleados de Pfizer directamente implicados en la realización del estudio.
    18. Participación en otros estudios en los 60 días previos, o cinco veces la semivida plasmática del fármaco en investigación (si se conoce) (la que sea más larga) antes de que comience este estudio y/o durante la participación en el estudio.
    19. Otras enfermedades graves agudas o crónicas, médicas o psiquiátricas, o anomalías en los resultados de laboratorio que podrían aumentar el riesgo asociado con la participación en el estudio, con la administración del medicamento en investigación o que podrían interferir con la interpretación de los resultados del estudio y, a discreción del investigador, harían que el paciente no fuera apto para incorporarse a este estudio.
    20. Mujeres embarazadas; mujeres en período de lactancia; mujeres con capacidad para concebir; hombres que no estén utilizando anticonceptivos de alta eficacia o no estén de acuerdo en continuar con los anticonceptivos de alta eficacia durante al menos 28 días tras la última administración de la dosis del medicamento en investigación.
    E.5 End points
    E.5.1Primary end point(s)
    Urinary albumin:creatinine ratio (UACR)
    Cociente albúmina/creatinina en orina (UACR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 12
    En la semana 12
    E.5.2Secondary end point(s)
    Urinary albumin:creatinine ratio (UACR).

    Urinary protein:creatinine ratio (UPCR).

    Estimated glomerular filtration rate (eGFR) using the abbreviated (4 variable) Modification of Diet in Renal Disease (MDRD) formula.

    Estimated glomerular filtration rate (eGFR) using the eGFRcystatin formula.

    Serum creatinine.

    Serum cystatin C.

    Plasma glycosylated hemoglobin (HbA1c).

    An assessment of PF-04634817 exposure.
    - Cociente albúmina/creatinina en orina (UACR).
    - Cociente proteína/creatinina en orina (UPCR).
    - La tasa de filtración glomerular estimada (TFGe) utilizando la abreviación (variable 4) de la fórmula de modificación de la dieta en la enfermedad renal (MDER).
    - La tasa de filtración glomerular estimada (TFGe) mediante la fórmula de la cistatina.
    - La creatinina sérica.
    - La cistatina C sérica.
    - La glucohemoglobina plasmática (HbA1c).
    - Una evaluación de la exposición al PF-04634817.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Urinary albumin:creatinine ratio (UACR) at Weeks 4, 8, 12 and 16.

    Urinary protein:creatinine ratio (UPCR) at Weeks 4, 8, 12 and 16.

    Estimated glomerular filtration rate (eGFR) using the abbreviated (4 variable) Modification of Diet in Renal Disease (MDRD) formula at Week 1 (Day 7), and Weeks 4, 8, 12 and 16.

    Estimated glomerular filtration rate (eGFR) using the eGFRcystatin formula at Weeks 12 and 16.

    Serum creatinine at Week 1 (Day 7), and Weeks 4, 8, 12 and 16.

    Serum cystatin C at Weeks 12 and 16.

    Plasma glycosylated hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16.

    An assessment of PF-04634817 exposure at Weeks 0, 1, 4, 8 and 12.
    - Cociente albúmina/creatinina en orina (UACR) en las semanas 4, 8, 12 y 16.
    - Cociente proteína/creatinina en orina (UPCR) en las semanas 4, 8, 12 y 16.
    - La tasa de filtración glomerular estimada (TFGe) utilizando la abreviación (variable 4) de la fórmula de modificación de la dieta en la enfermedad renal (MDER) en la semana 1 (día 7) y en las semanas 4, 8, 12 y 16.
    - La tasa de filtración glomerular estimada (TFGe) mediante la fórmula de la cistatina en las semanas 12 y 16.
    - La creatinina sérica en la semana 1 (día 7), y en las semanas 4, 8, 12 y 16.
    - La cistatina C sérica en las semanas 12 y 16.
    - La glucohemoglobina plasmática (HbA1c) en las semanas 4, 8, 12 y 16.
    - Una evaluación de la exposición al PF-04634817 en las semanas 0, 1, 4, 8 y 12.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) 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.8.2.4Number 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    Germany
    India
    Italy
    Korea, Republic of
    Peru
    Poland
    Romania
    Spain
    United States
    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
    LVLS
    La última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    E.8.9.2In all countries concerned by the trial months6
    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: 106
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 No
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 39
    F.4.2.2In the whole clinical trial 176
    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)
    As per standard of care.
    Según práctica clínica habitual.
    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 Decision2013-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-22
    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-Thu Apr 25 23:26:16 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA