European Trial about Effect of RimoNabant on Abdominal obese patients with dysLipidemia

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1440

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 > 27 kg/m² and < 40 kg/m²,
4)Willingness and ability to comply with the study protocol,
5)Waist Circumference > 88 cm in women; > 102 cm in men,
6)HDL cholesterol < 40 mg/dL (1.03 mmol/L) for men; < 50 mg/dL (1.29 mmol/L) for women,
7)Triglycerides = 400 mg/dL (4.52 mmol/L) and = 150 mg/dL (1.69 mmol/L),
8)LDL cholesterol up to 155 mg/dl (4.00 mmol/L) including patients on a stable dose of statins and/or Ezetimibe therapy for at least 8 weeks prior to screening,

Concomitant medications:

9)Current treatment with statins and/or ezetimibe and/or antihypertensive therapy must be at fixed and stable dose for at least 8 weeks prior to screening visit,
10)Patients, who are willing and in the opinion of the Investigator safely assumed to remain on stable and fixed doses of antihypertensive, and/or statins and/or ezetimibe 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)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
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,
9)Triglyceride level > 400 mg/dL (4.52 mmol/L),
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.
f.Omega-3 fatty acid approved medication
20)Current use of antidepressants (including bupropion)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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