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

• Register: EUCTR
• Last refreshed on: 24 January 2022
• Main ID: EUCTR2006-001711-30-GR
• Date of registration: 15/02/2007
• Prospective Registration: Yes
• Primary sponsor: sanofi aventis Groupe
• 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
• 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
• Date of first enrolment: 07/06/2007
• 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: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): yes

Countries of recruitment

Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Norway, Portugal, Slovakia, 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 = 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 euthyroïd status),
8) Established type 1 or 2 diabetes treated, or with at least 2 measures of fasting blood glucose = 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.
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

abdominally obese patients with impaired fasting blood glucose with or without other comorbidities
MedDRA version: 8.1 Level: LLT Classification code 10059179 Term: Abdominal obesity

Intervention(s)

Trade Name: Acomplia
Product Name: rimonabant
Product Code: SR141716
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: rimonabant
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)

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.

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

Secondary ID(s)

2006-001711-30-IE

RIMON_R_00961

Ethics review

Status: Approved
Approval date: 05/06/2007
Contact:

Results

• Results available: Yes
• Date Posted: 11/05/2016
• Date Completed: 04/02/2009
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-001711-30/results