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    The EU Clinical Trials Register currently displays   38869   clinical trials with a EudraCT protocol, of which   6391   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:2006-001711-30
    Sponsor's Protocol Code Number:RIMON R 00961
    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:2007-04-10
    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 number2006-001711-30
    A.3Full title of the trial
    A Pan-European randomized, parallel group, two-arm placebo-controlled, double-blind multicenter study of Rimonabant 20mg once daily in the treatment of abdominally obese patients with impaired fasting blood glucose with or without other comorbidities
    A.3.2Name or abbreviated title of the trial where available
    RIMON R 00961
    A.4.1Sponsor's protocol code numberRIMON R 00961
    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.3.9.1CAS number 168273-06-1
    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 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 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
    obese patients with impaired fasting blood glucose with or without other comorbidities.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level SOC
    E.1.2Classification code 10027433
    E.1.2Term Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose FPG , HDL-Cholesterol HDL-C and triglyceride TG levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with impaired fasting blood glucose and with or without associated comorbidities.
    E.2.2Secondary objectives of the trial
    To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference WC , body weight, glycemic parameters and lipid parameters. To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1 Informed consent must be obtained in writing for all subjects at enrollment into the study, 2 Male or female 18-75 years of age, 3 BMI 30Kg/m2, or 27kg/m2 if associated with risk factor s such as dyslipidemia, and 40kg/m2, 4 Willingness and ability to comply with the study protocol, 5 Waist Circumference 88 cm in women; 102 cm in men, 6 Confirmed by at least 2 measurements impaired Fasting Plasma Glucose FPG 8805; 100 mg/dl 5.6 mmol/L and 126 mg/dl 7.0 mmol/L in non diabetic patients, 7 LDL cholesterol 130 mg/dl 3.36 mmol/L including patients on a stable dose of statin therapy for at least 8 weeks prior to screening, Concomitant medications 8 Current treatment with statins and/or antihypertensive therapy must be at fixed and stable dose for at least 8 weeks prior to screening visit, 9 Patients, who are willing and in the opinion of the Investigator safely able to remain on stable and fixed doses of antihypertensive, and statins without adding additional medications or changing current treatment for the duration of the trial.
    E.4Principal exclusion criteria
    1 Pregnant or breast-feeding women, or women planning to become pregnant or breastfeed excluded by pregnancy test , 2 Absence of medically approved contraceptive methods for female of 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 see appendix A , 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 euthyro d status , 8 Established type 1 or 2 diabetes treated, or with at least 2 measures of fasting blood glucose 8805; 126 mg/dl /L, 9 Triglyceride level 400 mg/dL 4.52 mmol , 10 Systolic blood pressure 160 mm Hg or diastolic blood pressure 100 mmHg at screening visit, 11 Known severe renal dysfunction creatinine clearance 30 ml/min or nephrotic syndrome or urinalysis performed at screening by dipstick showing 2 or more protein, 12 Known severe hepatic impairment or AST and/or ALT 3 times the upper limit of normal at screening, 13 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 Cardiac abnormalities cardiac failure status NYHA III or IV, relevant acute abnormal finding seen on ECG at screening or within 6 months before screening, Any current malignancy or any cancer within the past five years except adequately treated basal cell skin cancer or cervix carcinoma in situ , Significant haematology abnormalities haemoglobin 100 g/L and/or neutrophils 1.5 G/L and/or platelets 100 G/L , 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, 14 Uncontrolled serious psychiatric illness such as a major depression, 15 History of alcohol or other substance abuse, 16 Hypersensitivity /intolerance to the active substance or to any of the excipients such as lactose, Concomitant medications prior to study entry 17 Administration of any investigational treatment drug or device within 30 days prior to screening, 18 Previous participation in a Rimonabant study, 19 Administration of any of the following within 3 months prior to screening visit a. Anti obesity drugs eg, sibutramine, orlistat , b. Other drugs for weight reduction phentermine, amphetamines , c. Herbal preparations for weight reduction, d. Nicotinic acid, fibrates or bile acid sequestrants , e. Prolonged use more than one week of systemic corticosteroids, neuroleptics. 20 Current use of antidepressants including bupropion
    E.5 End points
    E.5.1Primary end point(s)
    Mean change from baseline to month 12 in the co-primary endpoint FPG, HDL-C and triglyceride levels.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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 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 Yes
    E.8.1.4Double blind No
    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.8.5The 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
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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 2007-04-10. 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 state600
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3398
    F.4.2.2In the whole clinical trial 4830
    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 Decision2007-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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