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    Summary
    EudraCT Number:2007-002077-31
    Sponsor's Protocol Code Number:RIMON_L_01814
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-04-16
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-002077-31
    A.3Full title of the trial
    Effects of Rimonabant on urinary albumin excretion rate on the components of the metabolic syndrome in patients with type 2 diabetes mellitus and microalbuminuria on background ramipril treatment. A prospective, randomized, double-blind, placebo-controlled pilot study.
    A.3.2Name or abbreviated title of the trial where available
    EFFECTS
    A.4.1Sponsor's protocol code numberRIMON_L_01814
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 S.P.A
    B.1.3.4CountryItaly
    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 nameRIMONABANT
    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.3.10 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    Abdominal obese patients with type 2 diabetes mellitus and microalbuminuria.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10059179
    E.1.2Term Abdominal obesity
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effects of 9-month Rimonabant treatment as compared to placebo on overnight urinary albumin excretion (UAE) rate (considered as a continuous variable) in overweight (BMI >27), abdominal obese patients with T2DM and microalbuminuria (UAE 20-200 µg/min) on background ACE inhibitor (ramipril) therapy.
    E.2.2Secondary objectives of the trial
    To determine the effect of 9 months Rimonabant treatment versus placebo on changes in: Body weight, waist circumference (WC), BMI ; Glucose metabolic parameters (fasting glucose, fasting insulinemia, HbA1C, HOMA- IR); Lipid and lipoprotein profile (Total Cholesterol, HDL-C, LDL-C, triglyceride, apoprotein A1 and B); Hormone and adipokines concentrations (glucagone, leptin, adiponectin); GFR [as assessed by iohexol plasma clearance], albumin fractional clearance; Through (before study drug administration) and 24-hour blood pressure ; Need for antidiabetic, antihypertensive and lipid lowering agents ; Overall cardiovascular disease risk score ; Quality of life: IWQOL questionnaire . To determine the effect of 9 months Rimonabant treatment versus placebo on progression to macroalbuminuria (UAE >200 µg/min) and on regression to normoalbuminuria (UAE <20 µg/min). To assess the safety of 9 months Rimonabant treatment versus placebo in these patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Male or female 40-75 years of age; 2 T2DM (antidiabetic therapy and/or at least 2 values of fasting plasma glucose (FPG) >126 mg/dl) (ADA criteria); 3 BMI >27kg/m2 and <40kg/m2; 4 Waist Circumference >88 cm in women, >102 cm in men; 5 UAE 20-200 µg/min; 6 Treatment with ACEi or ARB as antihypertensive and/or antiproteinuric therapy (at least for 6 months and at least till 1 month prior to screening visit); 7 Informed consent must be obtained in writing for all subjects at enrollment into the study; 8 Willingness and ability to comply with the study protocol;
    E.4Principal exclusion criteria
    1 Inability to give a written informed consent; 2 Pregnant, breast feeding, pregnancy or breast feeding planning, and ineffective contraception in women with childbearing potential; 3 History of very low-calorie diet within 3 months prior to screening visit (lower than 1200 Kcal/day); 4 Weight change > 5 kg within 3 months prior to screening visit; 5 History of surgical procedures for weight loss (e.g., stomach stapling, bypass); 6 History of bulimia or anorexia nervosa as per DSM-IV criteria; 7 Presence of any clinically significant endocrine disease according to the investigator, in particular known abnormal TSH and free T4 blood level (Patients treated with thyroid replacement therapy must be on fixed and stable dose for at least 3 months prior to screening and must be in euthyroïd status); 8 Triglyceride level >400 mg/dL (4.52 mmol); 9 Systolic blood pressure > 160 mm Hg or diastolic blood pressure >100 mmHg at screening visit; 10 Known severe renal dysfunction (creatinine clearance < 30 ml/min) or nephrotic syndrome or urinalysis (performed at screening by dipstick) showing 2+ or more protein, or ischemic renal disease; 11 Known severe hepatic impairment or AST and/or ALT > 3 times the upper limit of normal at screening; 12 Presence of any condition (medical, including clinically significant abnormal laboratory tests, psychological, social or geographical) actual or anticipated that the investigator feels would compromise the patient’s safety or limit his/her successful participation to the study. In particular : a. Cardiac abnormalities: cardiac failure status NYHA III or IV, relevant acute abnormal finding seen on ECG at screening or within 6 months before screening; b. Any current malignancy or any cancer within the past five years (except adequately treated basal cell skin cancer or cervix carcinoma in situ); c. Significant haematology abnormalities (haemoglobin < 100 g/L and/or neutrophils <1.5 G/L and/or platelets <100 G/L); d. Acute psychiatric disorders, mental condition or clinical relevant history of epilepsy which could interfere with the patient’s compliance or safe participation in the study; 13 Ongoing major depressive illness; 14 Uncontrolled psychiatric illness; 15 Story of alcohol or other substance abuse; 16 Hypersensitivity/intolerance to the active substance or to any of the excipients such as lactose; 17 Concomitant medications prior and during the study: a. Administration of any investigational treatment (drug or device) within 30 days prior to screening; b. Previous participation in a Rimonabant study; c. Administration of any of the following within 3 months prior to screening visit: - Anti obesity drugs (eg, sibutramine, orlistat); - Other drugs for weight reduction (phentermine, amphetamines); - Herbal preparations for weight reduction; - Nicotinic acid, fibrates or bile acid sequestrants ; - Prolonged use (more than one week) of systemic corticosteroids, neuroleptics; d. Ongoing antidepressive treatment (including bupropion); e. Change of hypolipidemic therapy with statins within 8 weeks prior to screening visit.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline to month 9 in UAE.
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 2008-04-16. 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 state88
    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 Decision2008-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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