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    Summary
    EudraCT Number:2007-003013-14
    Sponsor's Protocol Code Number:EFC10144
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-09-17
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-003013-14
    A.3Full title of the trial
    A double-blind, randomized, placebo-controlled, parallel group study of rimonabant 20 mg daily for the treatment of Type 2 diabetic patients with nonalcoholic steatohepatitis (NASH)
    A.4.1Sponsor's protocol code numberEFC10144
    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 & development
    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 Yes
    D.2.1.1.1Trade name ACOMPLIA 20 mg film-coated tablets
    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.3.1Product namerimonabant
    D.3.2Product code A08XAX01
    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.3.10 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.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
    Diabetic patients with Non-Alcoholic Steato-Hepatitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10053219
    E.1.2Term Non-alcoholic steatohepatitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to demonstrate in patients with co-morbid Type 2 diabetes following 18 months treatment, the superiority of rimonabant 20 mg OD over placebo for improving the severity of NASH as measured by histological features of liver injury.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to demonstrate in patients with co-morbid diabetes following 18 months treatment, the superiority of rimonabant 20 mg OD over placebo:
    1) In severity of hepatic fibrosis as measured by hepatic fibrosis stage;
    2) In level of circulating plasma adiponectin;
    3) In level of circulating hyaluronate;
    4) In degree of insulin sensitivity;
    and,
    5) In AST/ALT level.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who are at least 18 years of age and with a diagnosis of NASH by liver biopsy performed within last 6 months (based on pre-defined histological criteria as confirmed by a central pathologist)

    2. Confirmed Type 2 DM diagnosed by fasting plasma glucose ≥ 126 mg/dl or 2-hour post load glucose ≥ 200 mg/dl during an OGTT (equivalent of 75 g anhydrous glucose in water) of at least 6 months duration.
    E.4Principal exclusion criteria
    Exclusion criteria related to study methodology
    1. Refusal or inability to give informed consent to participate in the study
    2. Average alcohol ingestion>21 units/wk(males)or>14 units/wk(females)[self-administered quantity-frequency and 7-day recall tests and confirmed by a family member]
    3. History of or presence of Type1 diab. mell.(requirement for insulin replacement and presence of autoantibodies, eg antipancreatic islet cell, insulin autoantibodies, tyrosine phosphate autoantibodies or GADAb)
    4. Hemoglobin A1C>9.0
    5. Other cause of chronic liver disease and/or hepatic steatosis(see protocol)
    6. Any contraindication to liver biopsy based on local standard for pre-liver biopsy risk assessment(for examples:see protocol)
    7. History of or planned gastrointestinal bypass surgery/intervention
    8. Hepatic Cirrhosis with a Child-Pugh classification of B or C(score>6)
    9. Concomitant Hepatocellular Carcinoma(HCC)(i.e. AFP>100 ng/mL on screening Liver Disease Panel or otherwise unexplained liver mass visualized on ultrasound or computed tomography examination of the liver)
    10. Previous hepatic transplantation
    11. Recent significant weight loss(>5% TBW within previous 6 months)
    12. ALT or AST >10 x ULN at screening or within 3 months of screening
    13. Recent(within 6 months of baseline liver biopsy and screening visit)or concomitant use of agent known to cause hepatic steatosis:corticosteroids, amiodarone, methotrexate, tamoxifen, tetracycline, high dose estrogens(standard HRT and oral contraceptive doses allowed),valproic acid
    14. Recent(within 3 months of baseline liver biopsy and screening visit)change in anti-diabetes treatment, such as a change in dose-regimen of anti-diabetes agent or introduction of new- antidiabetes agent(a specific diabetes medication/treatment page will be included in the CRF)
    15. Recent(within 3 months of baseline liver biopsy and screening visit) change in dose/regimen or introduction of:Vitamin E,Vitamin C,betaine,s-adenosyl methionine(SAM),ursodeoxycholate(UDCA),silymarin(silybin),fibrate,statin,pentoxyfilline,angiotensin II inhibitor
    16. Recent(within 3 months of baseline liver biopsy and screening visit) change in dose/regimen or introduction of weight loss agent such as:orlistat, sibutramine, rimonabant
    17. Any situation that in the Investigator’s opinion, may interfere with optimal study participation such as alcohol or drug abuse, domicile too distant from study site, potential non-compliance during the study or inability to cooperate because of a language problem or poor mental development
    18. Participation in any clinical study of an investigational agent within 30 days or five half-lives of the investigational agent, whichever is longer
    19. Presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic(if female), or any acute infectious disease or signs of acute illness that, in the opinion of the Investigator, might compromise the patient’s safe participation in this trial, including uncontrolled serious psychiatric illness such as major depression within the last 2 years, suicidal ideation of Type 4(1) or Type 5(2) on the C-SSRS or suicidal behavior within the last month, medical history of suicide attempt and history of other severe psychiatric disorder (eg schizophrenia or bipolar disorder). Any patient who scores 15 or higher on the PHQ-9 administered at the screening or randomization visit, or any patient whose response on the C-SSRS at the screening or randomization visit indicates suicidal behavior or is concerning for suicidal ideation (active suicidal ideation with some intent to act, without specific plan and active suicidal ideation with specific plan and intent), is NOT ELIGIBLE FOR RANDOMIZATION
    (1) Type 4 indicates Active Suicidal Ideation with Some Intent to Act, Without Specific Plan
    (2) Type 5 indicates Active Suicidal Ideation with Specific Plan and Intent
    20. Presence or history of multiple allergic reactions to drugs
    21. Presence or history of cancer within past 5 yrs with exception of adequately treated localized basal cell carcinoma of the skin, in situ cervical cancer or solid malignancy surgically excised in toto without recurrence for five years
    22. Women of childbearing potential not protected by effective contraceptive method of birth control or surgical sterilization and/or who are unwilling or unable to be tested for pregnancy
    Pregnancy status will be checked by serum pregnancy testing before initiation of study treatment and by urine pregnancy testing during the trial
    23. Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
    Exclusion criteria related to the sanofi-aventis compound
    24. Be pregnant or breastfeeding
    25. Hypersensitivity to rimonabant or to any of the excipients
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the mean change per year in NAS (NAFLD Activity score) between baseline and end of study biopsy evaluation.
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA69
    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 years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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 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 2007-09-17. Yes
    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 182
    F.4.2.2In the whole clinical trial 720
    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 Decision2008-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-11-05
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