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   43865   clinical trials with a EudraCT protocol, of which   7286   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:2011-005499-41
    Sponsor's Protocol Code Number:CLAF237A2411
    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:2012-10-30
    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 number2011-005499-41
    A.3Full title of the trial
    A double blind, double dummy, randomised, multi-centre study to assess the tolerability and efficacy profile of vildagliptin compared to gliclazide as dual therapy with metformin in Muslim patients with type 2 diabetes fasting during Ramadan
    Estudio multicéntrico, aleatorizado, doble ciego, con doble simulación para evaluar el perfil de tolerabilidad y eficacia de vildagliptina en comparación con gliclazida como terapia dual con metformina en pacientes musulmanes con diabetes tipo 2 en ayuno durante el Ramadán
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vildagliptin compared to gliclazide as dual therapy with metformin in Muslim patients with type 2 diabetes fasting during Ramadan
    Estudio doble ciego, aleatorizado, multicéntrico para demostrar en pacientes con DM2 musulmanes con el ayuno durante el Ramadán si hay menos eventos hipoglucémicos en la vildagliptina más metformina frente a la rama de gliclazida más metformina y la reducción de la HbA1c con el tratamiento con vildagliptina más metformina no es inferior a la gliclazida con metformina.
    A.3.2Name or abbreviated title of the trial where available
    STEADFAST
    A.4.1Sponsor's protocol code numberCLAF237A2411
    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 SponsorNovartis Farmacéutica S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica S.A.
    B.5.2Functional name of contact pointMarta Blay
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34933064200
    B.5.5Fax number34934290
    B.5.6E-maileecc.novartis@novartis.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 Yes
    D.2.1.1.1Trade name Galvus
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameVildagliptin
    D.3.2Product code LAF237
    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 INNVILDAGLIPTIN
    D.3.9.1CAS number 274901-16-5
    D.3.9.4EV Substance CodeSUB25199
    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.IMP: 2
    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.2.1.1.1Trade name Etform 500
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz GmbH
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameMetformin
    D.3.4Pharmaceutical form Film-coated 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 INNMETFORMIN HYDROCHLORIDE
    D.3.9.1CAS number 1115-70-4
    D.3.9.4EV Substance CodeSUB03200MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.IMP: 3
    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.2.1.1.1Trade name GLICLAZIDE SANDOZ
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameGliclazide
    D.3.4Pharmaceutical form Capsule
    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 INNGLICLAZIDE
    D.3.9.1CAS number 21187-98-4
    D.3.9.4EV Substance CodeSUB07921MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    Type 2 Diabetes Mellitus
    Diabetes Mellitus tipo 2
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes Mellitus
    Diabetes Mellitus tipo 2
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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 in Muslim patients with T2DM who plan to fast during the Ramadan fasting period:
    1. The proportion of patients with at least one HE (Hypoglycaemic event) is lower in the vildagliptin plus metformin arm compared to the gliclazide plus metformin arm during the Ramadan fasting period.
    2. The efficacy of vildagliptin plus metformin by testing the hypothesis that the HbA1C reduction with vildagliptin plus metformin is not inferior to that of gliclazide plus metformin from randomisation to the last visit.
    The study needs to meet both co-primary objectives to declare positive.
    Este estudio se declarará positivo si se cumplen los dos objetivos principales. Evaluar en pacientes musulmanes con DMT2 que tengan intención de ayunar durante el período de ayuno del Ramadán:
    1. La proporción de pacientes con al menos un AH es inferior en el brazo de vildagliptina más metformina en comparación con el brazo de glicazida más metformina durante el período de ayuno del Ramadán. Los AHs se definen en la Tabla 6-3.
    2. Se comprobará la eficacia de vildagliptina más metformina mediante la hipótesis de que la reducción de los niveles de HbA1c con vildagliptina más metformina no es inferior a la de glicazida más metformina desde la aleatorización hasta la última visita.
    E.2.2Secondary objectives of the trial
    1. evaluate the proportion of patients with an increase in HbA1c (<=0.3%), taken at visit 3 to the last visit with no HEs during Ramadan in the vildagliptin plus metformin (A) arm versus the gliclazide plus metformin arm (B).
    2. evaluate the efficacy of A by testing the hypothesis that the HbA1c reduction with A is superior to that of B from randomisation to the last visit
    3. Evaluate HbA1c change, taken at Visit 3 to study end.
    4. Evaluate the incidence of severe HEs during Ramadan
    5. Evaluate, in a selected sub-group (approx 25 patients/arm), 72h continuous subcutaneous glucose monitoring (CGM, masked to patients) comparing glucose fluctuation during the first 10 days of Ramadan.
    6. Evaluate the treatment adherence during Ramadan
    7. Evaluate the body weight change taken at Visit 3 to the last visit
    8. Evaluate the unscheduled visits to the HCP, at Visit 3 to the last visit
    9. Evaluate the number of days fasted during Ramadan
    10. Safety and tolerability
    1. Evaluar la proporción de pacientes sin un aumento de HbA1c (? 0,3%), registrados en la Visita 3 hasta la última visita sin que se registren AHs durante el Ramadán en el brazo de vildagliptina más metformina (A) versus el brazo de glicazida más metformina (B).
    2. Evaluar la eficacia de A mediante la comprobación de la hipótesis de que la reducción de HbA1c con A es superior a B desde la aleatorización hasta la última visita.
    3. Evaluar el cambio en los niveles de HbA1c, registrados en la Visita 3 hasta el final del estudio.
    4. Evaluar la incidencia de AHs severos durante el período de ayuno del Ramadán.
    5. Evaluar, en un subgrupo de pacientes (aprox 25/brazo), 72h de monitorización subcutánea continua de la glucosa (MCG, enmascarada para los pacientes) comparando la fluctuación de la glucosa durante los 10 primeros días del período de ayuno del Ramadán.
    6. Evaluar el cumplimiento del tratamiento durante el período de Ramadán.

    Para ver otros revisar el protocolo.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Substudy on evaluation of Glucose fluctuations through Continuous Glucose Monitoring (CGM):
    In a subset of about 50 patients (approximately 25 subjects in each arm), 72h continuous glucose monitoring (CGM) will be performed during the first 10 days of Ramadan fasting period at experienced centres.
    The CGM data will be downloaded to a computer for evaluation of glucose profiles and
    fluctuation. The mean amplitude of glycemic excursions (MAGE) will be used for assessing glucose fluctuations during the day. The MAGE during the day for each patient will be summarised descriptively (with mean, standard deviation, median, minimum and maximum) by treatment and day. A figure indicating the mean MAGE over time (in days) will be shown.
    Subestudio para evaluar las fluctuaciones de Glucosa con el CGM.
    En un subgrupo de unos 50 pacientes, se realizará una MCG de 72h durante los primeros 10 días del período de ayuno del Ramadán en centros con experiencia.
    Los datos sobre la MCG se descargarán en un ordenador para evaluar los perfiles de glucosa y su fluctuación. La amplitud media de las excursiones glucémicas (MAGE) se utilizará para evaluar las fluctuaciones de la glucosa durante el día.
    E.3Principal inclusion criteria
    - Confirmed T2DM diagnose
    - Plan to fast during Ramadan
    -Treated with a combination of a stable dose of metformin and an SU for at least 12 weeks and HbA1c <= 8.5% at Visit 1
    - Taking a sulfonylurea treatment less than 3 years prior to Visit 1
    - Body mass index (BMI) >= 22 AND <= 45 KG/M2 at Visit 1

    Other protocol-defined inclusion criteria may apply
    - Diagnóstico confirmado de DMT2 mediante criterios estándar.
    - Se deberá obtener el consentimiento informado por escrito antes de realizar cualquier evaluación.
    - IMC ? 22 hasta ? 45 kg/m2 en la Visita 1.
    - Haber sido tratados con una combinación de una dosis estable de metformina (?1500mg al día) y una SU durante al menos 12 semanas y tener unos niveles de HbA1c ? 8,5% en la Visita 1.
    - Haber estado tomando un componente de SU durante no más de 3 años antes de la Visita 1.
    - Tener intención de ayunar durante el Ramadán.

    Para ver otros criterios de inclusión, referir al protocolo.
    E.4Principal exclusion criteria
    -Pregnant or nursing (lactating) women
    -History of hypersensitivity to any of the study drugs
    -Patients taking any other anti-diabetes drug (oral or injection) other than metformin and an SU component
    - Inability to comply with the study procedures or medications
    Other protocol-definied exclusion criteria may apply
    - Mujeres embarazadas o en período de lactancia.
    - Historia de hipersensibilidad a cualquiera de los medicamentos del ensayo.
    - Pacientes que estén tomando cualquier otro fármaco antidiabético (oral o inyección) distinto a metformina y un componente de SU.
    - Incapacidad de cumplir con los procedimientos o las medicaciones del estudio.

    Para ver otros criterios de exclusión, referir al protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    1.Proportion of patients experiencing at least one Hypoglycaemic Evenet (HE) during the Ramadan fasting period
    2. Change in glycosylated hemoglobin (HbA1c) level from "Baseline" to "endpoint" to test non-inferiority
    1. La proporción de pacientes con al menos un AH durante el período de ayuno del Ramadán.
    2. Reducción de los niveles de HbA1c desde la aleatorización hasta la última visita para evaluar no inferioridad.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. 1 month
    2. from baseline to endpoint (average of 21 weeks)
    1. 1 mes
    2. desde la basal hasta el final (media de 21 semanas)
    E.5.2Secondary end point(s)
    1. Proportion of patients without an increase in HbA1c (<=0.3%) with no HE
    2. Change in HbA1c from visit 3 to endpoint
    3. Number of serious HE during the Ramadan fasting period
    4. Mean amplitude of glycaemic excursions (MAGE) to measure glucose fluctuations during the day
    5. Change in body weight from pre-Ramadan visit (Visit 3 ) to end of study
    6. Treatment adhererence during the Ramadan fasting period
    7. Number of unscheduled visit to health care professional
    8. Number of days fasted during the Ramadan fasting period
    9. Change in HbA1c level from baseline to endpoint to test superiority
    1. Evaluar la proporción de pacientes sin un aumento de los niveles de HbA1c (? 0,3%), sin que se registren AHs.
    2. Reducción de los niveles de HbA1c desde la aleatorización hasta la última visita.
    3. Evaluar la incidencia de AHs severos durante el período de ayuno del Ramadán.
    4. Evaluar la fluctuación de la glucosa durante el día.
    5. Evaluar el cambio en el peso corporal registrado en la Visita 3 hasta la última visita, en el brazo de vildagliptina más metformina en comparación con el brazo de glicazida más metformina.
    8. Evaluar las visitas no programadas que se realicen a los PS, en la Visita 3 hasta la última visita, en el brazo de vildagliptina más metformina en comparación con el brazo de glicazida más metformina.
    9. Evaluar el número de días de ayuno en el brazo de vildagliptina más metformina en comparación con el brazo de glicazida más metformina durante el período de ayuno del Ramadán.
    10. Seguridad y tolerabilidad.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.HbA1c timeframe: From any time within (week -4) to (day-1) before the start of Ramadan fasting period to within 4 weeks post-Ramadan fasting period; HE timeframe: 1month
    2. From anytime within (week -4) to (day -1) before the start of Ramadan fasting period to within 4 weeks post-Ramadan fasting period
    3. 1 month
    4. 10 days
    5. From any time within (week-4) to (day -1) before the start of Ramadan fasting period to within 4 weeks post-Ramadan fasting period
    6. 1month
    7. visit 3 (anytime from week-4 to day-1 before the start of the Ramadan fasting period) to visit 4 (within 4 weeks post-Ramadan fasting period)
    8. 1 month
    9. from baseline to endpoint (average of 21 weeks)
    1. HbA1c periodo: en cualquier momento desde semana -4 hasta día -1 antes de empezar el periodo de ayuno del Ramadan hasta las 4 semanas posteriores a la finalización del ayuno; HE periodo: 1 mes
    2. En cualquier momento desde la semana -4 hasta el día -1 antes de empezar el periodo de ayuno del Ramadan hasta las 4 semanas post-Ramadán.
    3. 1 mes
    4. 10 días
    5. En cualquier momento desde la semana -4 hasta el día -1 antes de empezar el periodo de ayuno del Ramadan hasta las 4 semanas post-Ramadán.
    6. 1 mes
    7. Visita 3 (en cualquier momento desde la semana -4 hasta el día -1 antes de empezar el periodo de ayuno del Ramadan hasta las 4 semanas post-Ramadán.
    8. 1 mes
    9. Desde la basal hasta final (media de 21 semanas)
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) Yes
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Denmark
    Egypt
    Germany
    India
    Indonesia
    Jordan
    Kuwait
    Lebanon
    Malaysia
    Russian Federation
    Saudi Arabia
    Spain
    Sweden
    Tunisia
    Turkey
    United Arab Emirates
    United Kingdom
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    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: 497
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 552
    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)
    None
    Ninguno
    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 Decision2012-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-05
    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-Mon Apr 29 21:30:01 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA