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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2007-002492-14
    Sponsor's Protocol Code Number:EFC10139
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-02-01
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2007-002492-14
    A.3Full title of the trial
    A randomized, double-blind, parallel-group, multicenter, multinational study to assess the long-term effect, over 1 year, of rimonabant 10 mg in comparison with rimonabant 20 mg after an initial treatment period of 6 months with rimonabant 20 mg in overweight or obese patients
    A.3.2Name or abbreviated title of the trial where available
    MODERATO
    A.4.1Sponsor's protocol code numberEFC10139
    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-aventis recherche & developpement
    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 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 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 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 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) 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 nameRimonabant
    D.3.2Product code SR141716
    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 codeSR141716
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with BMI > or = 30 kg/m2 or BMI > 27 kg/m2 with associated risk factors such as Type 2 Diabetes mellitus or Dyslipidemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 10.1
    E.1.2Level LLT
    E.1.2Classification code 10045260
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 10.1
    E.1.2Level LLT
    E.1.2Classification code 10058108
    E.1.2Term <Manually entered code. Term in E.1.1>
    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, over a period of 12 months (1 year), the effect on weight loss and weight maintenance of rimonabant 10 mg in comparison with rimonabant 20 mg in overweight/obese patients after an initial treatment period of 6 months with rimonabant 20 mg.
    E.2.2Secondary objectives of the trial
    - To assess the effect of rimonabant over a period of 12 months (1 year) on:
    - Waist circumference,
    - HDL-Cholesterol and triglycerides (TG),
    - Fasting plasma glucose (FPG), fasting-insulin.
    - To evaluate the long-term safety and tolerability of rimonabant 10 mg and 20 mg over a period of 12 months followed by a 75-day post treatment follow-up period (1 year + 75 days), after randomization, in overweight/obese patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria are to be applied for entering the open run-in period

    - Male or female patients aged > or = 18 years.
    - BMI > or = 30 kg/m² or BMI > 27 kg/m² with associated risk factor(s) such as type 2 diabetes or dyslipidemia.
    E.4Principal exclusion criteria
    A. Exclusion criteria related to study methodology

    Exclusion criteria for entering the open, run-in period
    - Weight loss > 5 kg within three months prior to screening Visit.
    - Patients with conditions/concomitant diseases making them non evaluable for the efficacy assessment:
    - Presence of any clinically significant endocrine disease according to the Investigator (euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least three months prior to screening Visit).
    - Presence of type 1 diabetes.
    - Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient’s safety or successful participation in the study, including uncontrolled serious psychiatric illness such as major depression, suicidal ideation and medical history of suicide attempt
    - Presence or history of cancer within the past five years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer.
    - Previous participation in a clinical study with rimonabant.
    - Administration of other investigational drugs within 30 days prior to screening Visit.
    - Absence of effective contraceptive method for females of childbearing potential.
    - Pregnancy.
    - Related to previous or concomitant medications that could bias evaluation of primary and secondary endpoints:
    - Within 3 months prior to screening visit and/or between the screening visit and the first visit of the open, run-in period:
    - Administration of anti-obesity drugs (sibutramine, orlistat).
    - Administration of other drugs for weight reduction (e.g., phentermine, amphetamines).
    - Administration of thyroid preparations or thyroxine (except in patients on stable replacement therapy)
    - Exenatide or other GLP-1 analogues,
    - Sitagliptin,
    - Insulin therapy.
    - Prolonged administration (more than one week) of neuroleptics.
    - Within 6 weeks prior to screening visit and/or between the screening visit and the first visit of the open, run-in period:
    - Administration of herbal preparations for weight reduction.
    - Administration of systemic long-acting corticosteroids.
    - Prolonged use (more than one week) of other systemic corticosteroids.
    - Change in the oral antidiabetic treatment (change of the dose, cessation, introduction, substitution).
    - Change in the lipid lowering treatment.
    - Change in the treatment with diuretics.
    - Related to laboratory findings:
    - Positive urine pregnancy test in females of childbearing potential at screening visit and the first visit of the open, run-in period.
    - Any relevant abnormality that could interfere with the efficacy or the safety assessments during the study drug administration.
    - Patients considered by the Investigator unsuitable candidates to receive an investigational drug.
    - Refusal or inability to give informed consent to participate to the study.
    - Presence of any other condition (e.g. geographic, social …) actual or anticipated, that the Investigator feels, would restrict or limit the patient’s participation for the duration of the study.

    Exclusion criteria for entering the double-blind treatment period
    - Absence of effective contraceptive method for females of childbearing potential.
    - Pregnancy.
    - Related to concomitant medications during the observation period that could bias evaluation of primary and secondary endpoints:
    - Within 3 months prior to screening visit and/or between the screening visit and the first visit of the open, run-in period:
    - Administration of anti-obesity drugs (sibutramine, orlistat).
    - Administration of other drugs for weight reduction (e.g., phentermine, amphetamines).
    - Administration of thyroid preparations or thyroxine (except in patients on stable replacement therapy).
    - Sitagliptin
    - Insulin therapy,
    • Prolonged administration (more than one week) of neuroleptics.- Prolonged administration (more than one week) of neuroleptics.- Related to laboratory findings:
    - Positive urine pregnancy test in females of childbearing potential at baseline visit.
    - Any relevant abnormality that could interfere with the efficacy or the safety assessments during the double-blind treatment period.


    B. Exclusion criteria related to rimonabant

    - Presence of uncontrolled serious psychiatric illness such as major depression, suicidal ideation and medical history of suicide attempt
    - Presence of hereditary problems of galactose intolerance (Lapp lactase deficiency, glucose galactose malabsorption).
    - Lactation.
    - Presence of severe renal or hepatic impairment.
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change in weight from baseline (randomization) to 12 months (1year).
    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 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) 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    same medicinal product but at higher dose (20 mg instead of 10 mg)
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days15
    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 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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 339
    F.4.2.2In the whole clinical trial 522
    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 Decision2008-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-02-27
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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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