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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2006-001711-30-NL |
Date of registration:
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28/09/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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:
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21/12/2006 |
Target sample size:
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4830 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001711-30 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Austria
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Belgium
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Bulgaria
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Czech Republic
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Denmark
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Finland
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France
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Greece
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Hungary
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Ireland
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Italy
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Lithuania
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Netherlands
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Norway
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Portugal
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Slovenia
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Sweden
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United Kingdom
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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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
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Intervention(s)
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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
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Primary Outcome(s)
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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.
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Primary end point(s): Mean change from baseline to month 12 in the co-primary endpoints : FPG, HDL-C and triglyceride levels.
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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.
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Secondary ID(s)
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2006-001711-30-IE
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RIMON_R_00961
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Source(s) of Monetary Support
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Results
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Results available:
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