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    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).

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    Summary
    EudraCT Number:2010-019009-40
    Sponsor's Protocol Code Number:A7331010
    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:2010-05-11
    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 number2010-019009-40
    A.3Full title of the trial
    Estudio clínico de Fase 2A, multicéntrico aleatorizado, doble ciego, controlado con placebo y con un fármaco activo, de diseño cruzado con dos cohortes y dos dosis, para la evaluación de la eficacia de la administración una vez al día de un inhibidor de la fosfodiesterasa 5 (PF 00489791) para el tratamiento del vasospasmo en el fenómeno de Raynaud primario y secundario.
    A PHASE 2A RANDOMIZED DOUBLE-BLINDED, PLACEBO AND ACTIVE CONTROLLED TWO COHORT TWO DOSES CROSS-OVER MULTI-CENTER CLINICAL STUDY TO ASSESS EFFICACY OF A ONCE DAILY ADMINISTRATION OF A PHOSPHODIESTERASE 5 INHIBITOR (PF-00489791) FOR THE TREATMENT OF VASOSPASM IN PRIMARY AND SECONDARY RAYNAUD?S PHENOMENON
    A.4.1Sponsor's protocol code numberA7331010
    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 SponsorPfizer, 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 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 namePF-00489791
    D.3.2Product code PF-00489791
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 853003-48-2
    D.3.9.3Other descriptive namePF-00489791
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.IMP: 2
    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-00489791
    D.3.2Product code PF-00489791
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 853003-48-2
    D.3.9.3Other descriptive namePF-00489791
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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
    Tratamiento del vasospasmo en el fenómeno de Raynaud primario y secundario.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10037912
    E.1.2Term Raynaud's phenomenon
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia de diferentes dosis de PF-00489791 sobre la puntuación RCS en pacientes con FRP y FRS.
    E.2.2Secondary objectives of the trial
    • Evaluar la eficacia de diferentes dosis de PF-00489791 sobre la frecuencia de crisis de FR en sujetos con FRP y FRS.
    • Evaluar la eficacia de diferentes dosis de PF-00489791 sobre la duración total de las crisis de FR en sujetos con FRP y FRS.
    • Evaluar la eficacia de diferentes dosis de PF-00489791 sobre la puntuación del dolor por el Raynaud en sujetos con FRP y FRS.
    • Evaluar la eficacia de diferentes dosis de PF-00489791 sobre los recuentos y la clasificación de las úlceras en sujetos con FRS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Un miembro debidamente cualificado del equipo del estudio del investigador deberá analizar y documentar la elegibilidad de los sujetos antes de su inclusión en el estudio.
    1. Varón o mujer de entre 18 y 65 años.
    2. Fenómeno de Raynaud activo definido como palidez digital episódica seguida de cianosis o eritema en respuesta al frío o las emociones.
    3. Los sujetos con FRS también deberán tener un diagnóstico de esclerodermia definida por los criterios del American College of Rheumatology (ACR) o por la presencia de al menos 3 de las 5 características del síndrome CREST (calcinosis, fenómeno de Raynaud, dismotilidad esofágica, esclerodactilia y telangiectasias).
    4. Los sujetos deben tener un mínimo de siete crisis de FR por semana en cinco o más días por semana. Este hecho lo podrá comunicar el paciente en la visita de selección.
    5. Enfermedad estable y necesidad de medicación durante los dos meses previos. Se permitirá el uso de bloqueantes de los canales de calcio, pero los sujetos no podrán modificar la dosis ni comenzar con bloqueantes de los canales de calcio una vez incluidos en el estudio. Se permitirá el uso de IECA en caso necesario por hipertensión y/o nefropatía relacionada con la esclerodermia.
    6. Tratamiento inmunodepresor inalterado tres meses antes del tratamiento con PF-00489791.
    7. Sujetos dispuestos a cumplir las visitas programadas, el plan de tratamiento, los análisis clínicos y otros procedimientos del estudio y capaces de hacerlo.
    8. Prueba de un documento de consentimiento informado, firmado y fechado personalmente, que indique que se ha informado al sujeto (o a su representante legal) de todos los aspectos pertinentes del estudio.
    E.4Principal exclusion criteria
    No podrán participar en el estudio los sujetos que se encuentren en cualquiera de las circunstancias siguientes:
    1. Fumadores activos. Se define a los ex fumadores como los que no han fumado durante al menos tres meses.
    2. Sujetos que utilizan tratamientos para dejar de fumar (por ejemplo, parches de nicotina).
    3. Sujetos con antecedentes de ictus, infarto de miocardio o arritmia potencialmente mortal en los últimos seis meses.
    4. Sujetos con hipertensión no controlada (PA sistólica > 150 mm Hg, PA diastólica > 100 mm Hg).
    5. Sujetos con diabetes mellitus no controlada con HbA1c > 7 %.
    6. Sujetos con insuficiencia cardíaca grave (clase IV de la clasificación de la New York Heart Association) o angina inestable en los últimos seis meses.
    7. Sujetos con inestabilidad hemodinámica o con presión arterial sistólica inferior a 90 mm Hg o hipotensión ortostática sintomática.
    8. Sujetos con insuficiencia hepática (ALT y/o AST > 3 veces el límite superior de la normalidad (LSN) y/o bilirrubina &#8805; 2 mg/dl) en la selección.
    9. Sujetos con insuficiencia renal (creatinina sérica > 2,5 veces el LSN) en la selección.
    10. Sujetos que se han sometido a una simpatectomía quirúrgica en los 12 meses previos.
    11. Sujetos con antecedentes de trombosis venosa profunda o linfedema de las extremidades superiores en los tres meses previos.
    12. Pacientes con alteraciones degenerativas hereditarias de la retina (como retinitis pigmentaria) o antecedentes de neuropatía óptica isquémica anterior no arterítica (NAION) o retinopatía diabética proliferativa sin tratar.
    13. Pacientes con intolerancia o alergia a los inhibidores de la PDE5 o con antecedentes de varias alergias de importancia clínica.
    14. Sujetos que actualmente tomen inhibidores de la fosfodiesterasa (en las 48 horas previas al día 0 de entrada en el estudio) o con uso crónico previo de inhibidores de la fosfodiesterasa por cualquier motivo (por ejemplo, sildenafilo, tadalafilo o vardenafilo).
    15. Sujetos que no pueden retirar los vasodilatadores o alguno de los tratamientos siguientes durante 14 días antes del comienzo del estudio:
    • Inhibidores potentes del citocromo P4503A4, por ejemplo, itraconazol, eritromicina, ke toconazol o inhibidores de la proteasa;
    • Nitratos o donantes de óxido nítrico;
    • Ritonavir o nicorandilo;
    • Teofilina;
    • Alfabloqueantes;
    • Iloprost;
    • Bosentano;
    • AINE;
    • IECA o inhibidores del receptor de la angiotensina;
    • Corticosteroides (a menos que sean en una dosis estable inferior o igual a 10 mg de prednisona al día o equivalente durante al menos 3 meses);
    • Ácido acetilsalicílico (a menos que sea en una dosis de 81 mg al día);
    • Dipiridamol;
    • Otros antiagregantes plaquetarios (por ejemplo, ticlopidina o clopidogrel).
    16. Sujetos con alcoholismo o drogadicción activa en los 5 últimos años.
    17. Sujetos con antecedentes de infección por el VIH o por hepatitis B o C.
    18. Mujeres que están embarazadas o en período de lactancia o que se plantean quedarse embarazadas en los próximos 4 meses. Mujeres en edad fértil que no se muestran dispuestas o no pueden utilizar un método anticonceptivo aceptable tal y como se recoge en este protocolo desde al menos 14 días antes de la primera dosis de la medicación del estudio y hasta 14 días después de la última dosis del fármaco del estudio.
    19. Sujetos con participación previa en un ensayo clínico de un fármaco o agente en investigación en los 30 días anteriores a la entrada en el estudio.
    20. Cualquier otro trastorno médico o psiquiátrico grave, agudo o crónico, o cualquier anomalía de laboratorio que pueda aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en investigación o interferir en la interpretación de los resultados del estudio y, en opinión del investigador, impedir la participación en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Variación de la puntuación RCS durante la cuarta semana de tratamiento con respecto al valor basal, comparando el fármaco activo con placebo.
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.6Cross over Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    As per protocol
    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 months1
    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 months1
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 124
    F.4.2.2In the whole clinical trial 208
    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)
    Normal treatment
    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 Decision2010-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-31
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