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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2005-002942-20
    Sponsor's Protocol Code Number:EFC5826
    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:2005-11-25
    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 number2005-002942-20
    A.3Full title of the trial
    Ensayo aleatorizado, multinacional, multicéntrico, doble ciego, controlado con placebo, con dos grupos paralelos, de rimonabant 20 mg od, para la reducción del riesgo de acontecimientos cardiovasculares mayores en pacientes con obesidad abdominal con factores de riesgo asociados
    A.3.2Name or abbreviated title of the trial where available
    CRESCENDO
    A.4.1Sponsor's protocol code numberEFC5826
    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 SponsorSanofi-Synthelabo Recherche
    B.1.3.4CountryFrance
    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 Information not present in EudraCT
    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 namerimonabant
    D.3.2Product code SSR141716
    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.3.8INN - Proposed INNrimonabant
    D.3.9.1CAS number 168273-06-01
    D.3.9.2Current sponsor codeSSR141716 form 2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboFilm-coated tablet
    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
    Pacientes con obesidad abdominal de elevado riesgo para acontecimientos cardiovasculares (infartos de miocardio, ictus, o muerte cardiovascular ).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10051615
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostrar la eficacia de rimonabant frente a placebo para reducir el riesgo de infartos de miocardio, ictus, o muerte cardiovascular en pacientes con obesidad abdominal de elevado riesgo para dichos acontecimientos cardiovasculares.
    E.2.2Secondary objectives of the trial
    Demostrar la eficacia de rimonabant frente a placebo para reducir el riesgo de infarto de miocardio, ictus, muerte cardiovascular, u hospitalización por una causa cardiovascular (angina inestable, ataque isquémico transitorio, síncope, o procedimiento revascularizador urgente) en pacientes con obesidad abdominal de elevado riesgo para dichos acontecimientos cardiovasculares.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Obtención del consentimiento informado por escrito
    2. Hombres y mujeres de 55 años de edad o mayores, Y
    3. Presencia de obesidad abdominal, con una circunferencia de cintura superior a 102 cm (40 pulgadas) para hombres y superior a 88 cm (35 pulgadas) en mujeres en tres mediciones sucesivas en la visita basal, Y
    4. Presencia de al menos un equivalente de riesgo de enfermedad cardiaca coronaria (CHD) O dos factores de riesgo cardiovascular importantes

    Equivalentes de riesgo de enfermedad cardiaca coronaria:

    a) Infarto de miocardio (IM) reciente (en el plazo de los últimos 3 años) (dos de los tres criterios siguientes deben satisfacerse):
    • Dolor torácico isquémico característico o dolor en zonas referenciadas asociadas o síntomas equivalentes de angina,
    • Elevación de CK (al menos dos veces el límite superior de los valores normales para ese laboratorio) y/o CK-MB (al menos dos veces el límite superior de los valores normales para el laboratorio) y/o troponina T o I (al menos por encima del límite superior de normalidad para el laboratorio),
    • Desarrollo de ondas Q en al menos dos derivaciones adyacentes del ECG, o desarrollo de una nueva onda R dominante en V1.

    b) Angina estable con enfermedad coronaria multivaso documentada (definida como estenosis superior al 50% en al menos dos arterias coronarias epicardiales en la angiografía), y/o antecedentes de intervención coronaria percutánea multivaso (ICP) o injerto de derivación de arteria coronaria (CABG) multivaso JUNTO CON al menos uno de los tres criterios siguientes:
    • Angina pectoris inducida por ejercicio actual
    • Prueba de estrés del ECG positiva (depresión ST superior a 2 mm con segmentos ST basales normales)
    • Defecto reversible por imagen de perfusión miocárdica o anomalía de movimiento de la pared inducida por estrés en la prueba ecocardiográfica de estrés

    c) Enfermedad cerebrovascular reciente (en el plazo de los últimos 3 años), evidenciado por un episodio cerebrovascular isquémico (todos los criterios deben ser satisfechos):
    • Un déficit neurológico focal
    • Sin evidencias de origen cardio-embólico
    • Sin evidencia de origen no vascular en TAC o IRM

    Deben haberse realizado un TAC o IRM para documentar si hay una lesión y descartar enfermedad neurológica no isquémica.

    d) Enfermedad arterial periférica (PAD) sintomática documentada (uno de los siguientes criterios principales debe satisfacerse):
    • Claudicación intermitente actual (criterios OMS, por ejemplo dolor de pierna que aparece únicamente al andar y desaparece en menos de 10 minutos al estarse quieto) de supuesto origen aterosclerótico JUNTO CON índice tobillo/braquial igual a o inferior a 0,85 en cualquier pierna en reposo, O
    • Antecedentes de claudicación intermitente (criterios OMS anteriores) JUNTO CON intervención previa por amputación, o cirugía vascular reconstructiva, o angioplastia en una o ambas piernas debido a enfermedad aterosclerótica,

    e) Diabetes mellitus tipo 2 (glucosa plasmática en ayunas igual a o superior a 126 mg/dL ī›7,0 mmol/Lī en dos o más ocasiones)

    Factores de riesgo cardiovascular mayores:

    f) Síndrome metabólico, diagnosticado por la presencia de al menos 2 de los siguientes factores de riesgo (si se cumplen 3 de los factores de riego mencionados a continuación, esto es equivalente a dos factores de riesgo importantes y el paciente es elegible):
    • Concentración de triglicéridos en ayunas igual o superior a 150 mg/dL (1,69 mmol/L)
    • Colesterol-HDL inferior a 40 mg/dL (1,03 mmol/L) para hombres o inferior a 50 mg/dL (1,28 mmol/L) para mujeres
    • Glucosa plasmática en ayunas igual o superior a 110 mg/dL (6,1 mmol/L)
    • Presión arterial igual o superior a 130 mmHg sistólica y/o 85 mmHg diastólica en la visita basal

    g) Enfermedad cerebrovascular (al menos uno de los tres criterios siguientes debe satisfacerse):
    • Enfermedad asintomática de las arterias carótida, intracraneal, y/o vertebral, con una estenosis superior al 50%
    • Al menos una placa carotídea en la ultrasonografía, definida como una zona distinta con un grosor de la íntima-media (IMT) que supera dos veces la de las zonas colindantes, O
    • Procedimiento de revascularización cerebrovascular previa

    h) Enfermedad arterial renal, con estenosis superior al 60% en RM angiográfica, TAC angiográfico, o angiografía, o procedimiento de revascularización previa
    i) Historia previa de reparación de aneurisma aórtico abdominal
    j) Índice tobillo-braquial asintomático inferior a 0,85
    k) hs-PCR elevado superior a 3 mg/L
    l) Hombres de 65 años o más o mujeres de 70 años o más
    E.4Principal exclusion criteria
    * Relacionados con las características generales del paciente:
    1. Obesidad debida a alteración endocrina conocida, como hipotiroidismo, o hipopituitario u otra enfermedad endocrina
    2. Mujer embarazada o en periodo de lactancia, o mujer que planea quedarse embarazada o amamantar
    3. Dieta muy baja en calorías (1.200 calorías al día o menos) o procedimiento quirúrgico para perder peso (por ejemplo, grapado de estómago, bypass, etc.) en los 6 meses previos a la vista basal
    4. Presencia de alguna condición médica severa o edad avanzada de forma que no se prevé
    que el paciente sobreviva durante el periodo de seguimiento del estudio previsto
    5. Presencia de cualquier otra alteración médica o psicológica que, en opinión del Investigador, pueda comprometer la participación segura del paciente
    6. Presencia de cualquier condición (médica, psicológica, social o geográfica), actual o prevista, que el Investigador considere que podría restringir o limitar la participación del sujeto en el transcurso del estudio
    7. Recepción de algún tratamiento en investigación (fármaco o dispositivo) en los 30 días previos a la visita basal
    8. Participación previa en un estudio de rimonabant
    9. Alergia conocida a rimonabant o los excipientes

    * Relacionados con la condición cardiovascular:
    10. Enfermedad cardiovascular clínicamente significativa que, en opinión del investigador, es probable que precise intervención (ICP, CABG, reparación/sustitución de válvula, trasplante de corazón, PTA, cirugía bypass periférico, endarterectomía, etc.) en el mes siguiente a la aleatorización
    E.5 End points
    E.5.1Primary end point(s)
    Primera aparición de uno de los siguientes acontecimientos adjudicados por el Comité de Acontecimientos Clínicos
    • Cualquier IM,
    • Cualquier ictus, o
    • Muerte cardiovascular
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Último paciente, última visita.
    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 months50
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months50
    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) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-11-25. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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.4.2.2In the whole clinical trial 17000
    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 Decision2006-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-04-29
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    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
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