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    Summary
    EudraCT Number:2006-002951-33
    Sponsor's Protocol Code Number:RIMON_L_01031
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-01-27
    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 number2006-002951-33
    A.3Full title of the trial
    A 12-month multicentre, randomised, double-blind, placebo-controlled study with two parallel groups to assess the effects of rimonabant 20 mg in patients with abdominal obesity and microalbuminuria, with type 2 diabetes mellitus or dyslipidaemia with or without other cardiometabolic risk factors.
    ?Estudio multicéntrico, aleatorizado, doble ciego, de dos grupos paralelos, controlado con placebo y de 12 meses de duración de los efectos de rimonabant 20 mg en pacientes con obesidad abdominal y microalbuminuria, con diabetes mellitus tipo 2 o dislipemia, con o sin otros factores de riesgo cardiometabólico?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to assess the effects of rimonabant 20 mg in patients with abdominal obesity and microalbuminuria, with type 2 diabetes mellitus or dyslipidaemia with or without other cardiometabolic risk factors.
    Estudio de los efectos de rimonabant 20 en pacientes con obesidad abdominal y microalbuminuria, con diabetes mellitus tipo 2 o dislipemia, con o sin otros factores de riesgo cardiometabólico
    A.3.2Name or abbreviated title of the trial where available
    RIALTO
    RIALTO
    A.4.1Sponsor's protocol code numberRIMON_L_01031
    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 Sponsorsanofi-aventis, 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 supportsanofi-aventis, s.a.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla 2
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.5Fax number-
    B.5.6E-mailES-unidadestudiosclinicos@sanofi.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 ACOMPLIA
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis
    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.3.4Pharmaceutical 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 INNrimonabant
    D.3.9.2Current sponsor codeSR141716
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 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
    Patients with abdominal obesity, with type 2 diabetes mellitus or dyslipidaemia, with or without other cardiometabolic risk
    factors.
    Pacientes con obesidad abdominal y microalbuminuria, con diabetes mellitus tipo 2 o dislipemia, con o sin otros factores de riesgo cardiometabólico.
    E.1.1.1Medical condition in easily understood language
    Patients with abdominal obesity, with type 2 diabetes mellitus or dyslipidaemia, with or without other cardiometabolic risk
    factors.
    Pacientes con obesidad abdominal y microalbuminuria, con diabetes mellitus tipo 2 o dislipemia, con o sin otros factores de riesgo cardiometabólico.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10059179
    E.1.2Term Abdominal obesity
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect on microalbuminuria levels of treatment with rimonabant 20 mg
    versus a placebo during a 12 month period. The treatment was administered in
    conjunction with a slightly reduced calorie diet to patients with abdominal obesity, with
    type 2 diabetes mellitus or dyslipidaemia, with or without other cardiometabolic risk
    factors.
    Evaluar el efecto del tratamiento con rimonabant 20 mg frente a placebo durante un período de 12 meses en los niveles de microalbuminuria, al ser administrado junto a una dieta levemente hipocalórica a pacientes con obesidad abdominal, con diabetes mellitus tipo 2 o dislipemia, con o sin otros factores de riesgo cardiometabólico.
    E.2.2Secondary objectives of the trial
    Percentage of patients in both arms of the study whose levels of microalbuminuria decrease, stabilise, increase towards macroalbuminuria or are unchanged after 12 months of treatment with rimonabant or placebo.
    To assess the effect of treatment with rimonabant 20 mg versus placebo over a 12 month period on:
    Anthropometric Variables (weight and waist circumference).
    Glycaemia profile: fasting glycaemia, fasting insulinaemia and HbA1c.
    Lipid and lipoprotein profile: triglycerides, total cholesterol, HDL-C, LDL-C, apolipoproteins A1 and B.
    Inflammatory markers: hs-CRP, IL-6, TNF-?.
    Adipocytokines: adiponectin.
    Blood pressure.
    Glomerular filtration rate.
    To assess the quality of life: questionnaire IWQOL was completed at baseline visit
    and at 3, 6, and 12 months.
    Safety parameters:
    - Incidence of adverse events in each group, including neuropsychiatric events
    - Laboratory assessments.
    ? Porcentaje de pacientes en ambos brazos del estudio cuyos niveles de microalbuminuria disminuyen, se normalizan, aumentan a macroalbuminuria o no se alteran tras 12 meses de tratamiento con rimonabant o placebo.
    ? Evaluar el efecto del tratamiento con rimonabant 20 mg versus placebo durante un período de 12 meses sobre:
    - Variables antropométricas (peso y perímetro de cintura).
    - Perfil glucémico: glucemia en ayunas, insulinemia en ayunas y HbA1c.
    - Perfil lipídico y lipoproteico: triglicéridos, colesterol total, HDL-C, LDL-C, Apolipoproteínas A1 y B.
    - Marcadores inflamatorios: hsPCR, IL-6, TNF-?.
    - Adipocitocinas: adiponectina.
    - Presión arterial.
    - Tasa de filtración glomerular.
    ? Evaluar la calidad de vida: cuestionario IWQOL (Anexo 1) en la visita basal, 3, 6, y 12 meses.
    ? Parámetros de seguridad:
    - Incidencia de acontecimientos adversos en cada grupo, incluidos los neuropsiquiátricos (Anexo 2)
    - Evaluaciones analíticas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or women aged ? 30 years and < 75 years.
    2. BMI > 27 kg/m2 and < 40 kg/m2.
    3. Willingness and ability to comply with the study protocol.
    4. Written informed consent at the time of enrolment into the study.
    5. Waist circumference > 102 cm in men and > 88 cm in women.
    6. Microalbuminuria ? 20 mg/g creatinine and < 300 mg/g creatinine in at least
    two of three morning urine samples taken on 3 separate days prior to the
    baseline visit.
    7. Type 2 diabetes and/or dyslipidaemia.
    Generales: incluyendo cambios reflejados en la Enmienda nº 1 de fecha 16 de octubre 2006, en la Enmienda nº 2 de fecha 22 de marzo de 2007 y en la Enmienda nº 3 de fecha 07 de noviembre de 2007 y Enmienda nº 4 de 30 de abril de 2008

    1. Hombres o mujeres de edad ?30 años y ? 75 años.
    2. IMC > 27 kg/m2 y < 40 kg/m2.
    3. Disposición y capacidad para cumplir con el protocolo del estudio.
    4. Consentimiento informado por escrito en el momento de la inclusión en el estudio.
    5. Perímetro de cintura > 102 cm en los hombres y > 88 cm en las mujeres.
    6. Microalbuminuria ? 20 mg/g creatinina y < 300 mg/g creatinina en al menos dos de tres muestras de orina matinal de tres días diferentes previos a la visita basal
    7. Diabéticos tipo 2 y/o dislipémicos

    DEFINICIÓN PACIENTE DIABÉTICO TIPO 2 PARA ESTE ESTUDIO:

    Diagnóstico clínico de DMT2 según criterio de la ADA en tratamiento con dieta + sulfonilurea o glinida y/o metformina y HbA1c < 9 %. El tratamiento antidiabético debe ser estable como mínimo 4 semanas antes de la visita de selección.

    DEFINICIÓN PACIENTE DISLIPÉMICO PARA ESTE ESTUDIO:

    Paciente no tratado o tratado con estatinas y/o ezetimibe y/o fibratos a dosis estable como mínimo las 8 semanas anteriores a la visita de selección con LDL-C < 155 mg/dl (4,00 mmol/L)

    Y que cumpla al menos uno de los criterios siguientes:

    a. HDL-C < 40 mg/dL (1,03 mmol/L) para hombres y < 50 mg/dL (1,29 mmol/L) para mujeres.
    b. Trigliceridemia ?150 mg/dL (1,69 mmol/l) y ? 400 mg/dL (4.52 mmol/L)
    E.4Principal exclusion criteria
    1. Breastfeeding or pregnant women or who expect to become pregnant.
    2. Non-use of approved methods of contraception in women of child-bearing
    potential.
    3. History of very low calorie diet in the 3 months prior to the screening visit
    (<1200 kcal/day).
    4. Change in weight > 5 kg in the 3 months prior to the screening visit.
    5. History of surgery for weight loss (such as vertical banded gastroplasty,
    gastric by-pass, etc.)
    6. History of bulimia or anorexia nervosa according to DSM-IV definition.
    7. Any clinically significant endocrine disorder, in the opinion of the
    investigator, especially known alterations in the blood concentration of TSH
    and free T4.
    Generales: incluyendo cambios reflejados en la Enmienda nº 1 de fecha 16 de octubre 2006, en la Enmienda nº 2 de fecha 22 de marzo de 2007 y en la Enmienda nº 3 de fecha 07 de noviembre de 2007 y Enmienda nº 4 de 30 de abril de 2008

    1. Mujeres lactantes o embarazadas o que tengan previsto quedar embarazadas.
    2. Ausencia de métodos anticonceptivos aprobados para uso clínico en mujeres en edad fértil.
    3. Antecedentes de dieta altamente hipocalórica en los 3 meses previos a la visita de selección (<1200 kcal/día).
    4. Cambio de peso > 5 kg en los 3 meses anteriores a la visita de selección.
    5. Antecedentes de intervenciones quirúrgicas para perder peso (como, gastroplastia vertical anillada, derivación gástrica, etc.)
    6. Historia de bulimia o anorexia nerviosa por criterio DSM-IV (Anexo 3).
    7. Presencia de cualquier enfermedad endocrina clínicamente significativa a criterio del investigador, especialmente alteraciones conocidas de las concentraciones sanguíneas de THS y T4 libre.
    Nota: se pueden incluir pacientes eutiroideos sometidos a tratamiento sustitutivo si la dosis de tiroxina permanece estable durante un mínimo de 3 meses antes de la visita de selección.
    8. Diabetes tipo 1
    9. Trigliceridemia > 400 mg/dL (4,52 mmol/L)
    10. Disfunción renal grave (aclaramiento de creatinina < 30 ml/min) o tasa de filtración glomerular < 30 ml/min/1,73 m2 (MDRD-4 fórmula de variables).
    11. Hepatitis crónica o hepatopatía clínicamente significativa conocida o ALT y/o AST > 3x el límite superior del rango normal en la visita de selección.
    12. PAS> 160 mmHg o PAD > 100 mmHg en la selección (previo a la randomización).
    13. Presencia de cualquier situación (médica, incluidas las pruebas analíticas con alteraciones clínicamente significativas, fisiológica, social o geográfica) real o prevista que el investigador considere que afectaría a la seguridad del paciente o limitaría el éxito de su participación en el estudio. Sobre todo:
    ? Alteraciones cardíacas: insuficiencia cardíaca NYHA III o IV, alteraciones agudas significativas observadas en el ECG en la selección o en los 6 meses anteriores a la selección,
    ? Cualquier proceso maligno o cáncer en los cinco últimos años (excepto carcinoma basocelular o carcinoma de cuello uterino in situ tratados),
    ? Alteraciones importantes en los parámetros hematológicos (hemoglobina < 100 g/L y/o neutrófilos < 1.500 células/?l y o plaquetas < 100.000 células/?l),
    ? Enfermedades del sistema nervioso central como por ejemplo epilepsia.
    ? Depresión mayor u otras enfermedades psiquiátricas.
    ? Pacientes con ideación suicida en el momento actual y/o historia de ideación suicida y trastorno depresivo.

    14. Historia de abuso de alcohol u otras sustancias (excepto tabaco).
    15. Hipersensibilidad / intolerancia a la sustancia activa o alguno de los excipientes como lactosa.

    Medicación concomitante previa a la visita de selección

    16. Administración de cualquier tratamiento en fase de investigación clínica (fármaco o producto sanitario) en los 30 días previos a la visita de selección
    17. Tratamiento previo con rimonabant.
    18. Administración de cualquiera de los siguientes productos en los 3 meses previos a la visita de selección
    - Fármacos contra la obesidad (como, sibutramina o orlistat).
    - Otros fármacos adelgazantes (fentermina, anfetaminas).
    - Fitopreparados adelgazantes.
    - Ácido nicotínico, secuestradores de ácidos biliares o fármacos Omega 3 (p ej. Omacor)
    - Uso prolongado (más de una semana) de corticosteroides sistémicos o neurolépticos
    - Antidepresivos (incluido bupropion)
    - Insulina (excepto un episodio de administración< 7 días)
    - tiazolidinodionas, inhibidores de la ?-glucosidasa o cualquier asociación de estos fármacos antidiabéticos (excepto asociación de sulfonilureas o glinidas y metformina)
    19. En los pacientes diabéticos tipo 2, inicio o cambio del tratamiento con sulfonilureas o glinidas y/o metformina, en las 4 semanas previas a la visita de selección.
    20. Inicio o cambio del tratamiento antihipertensivo en las 12 semanas previas a la visita de selección.
    21. Inicio o cambio del tratamiento con estatinas y/o ezetimibe y/o fibratos en las 8 semanas previas a la visita de selección.
    E.5 End points
    E.5.1Primary end point(s)
    Change between baseline and month 12 in microalbuminuria levels
    Cambio relativo entre la situación basal y el Mes 12 en el nivel de microalbuminuria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    month 12
    Mes 12
    E.5.2Secondary end point(s)
    -
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    -
    -
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open 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 concerned43
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Close database
    Cierre de la base de datos.
    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 months33
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months33
    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.1.2.1Number of subjects for this age range: 550
    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 state550
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 550
    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 Decision2006-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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