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 - RIMON R 00961

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-001711-30-IT
• Date of registration: 10/04/2007
• Prospective Registration: Yes
• Primary sponsor: SANOFI-AVENTIS S.P.A
• Public title: 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 - RIMON R 00961
• Scientific title: 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 - RIMON R 00961
• Date of first enrolment: 25/05/2007
• Target sample size: 4830
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001711-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Norway, Portugal, Slovenia, Sweden, United Kingdom

Key inclusion & exclusion criteria

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

obese patients with impaired fasting blood glucose with or without other comorbidities.
MedDRA version: 9.1 Level: SOC Classification code 10027433 Term: Metabolism and nutrition disorders

Intervention(s)

Product Name: rimonabant
Pharmaceutical Form: Film-coated tablet
CAS Number: 168273-06-1
Current Sponsor code: SR141716
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Mean change from baseline to month 12 in the co-primary endpoint FPG, HDL-C and triglyceride levels.

Main Objective: 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.

Secondary Objective: 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.

Secondary ID(s)

2006-001711-30-IE

RIMON R 00961