An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effect of rimonabant 20 mg on HDL (high density lipoprotein) cholesterol and on TG (triglycerides) plasma levels over a period of one year when prescribed with a hypocaloric diet (600 kcal deficit per day) in abdominally obese patients with atherogenic dyslipidemia (low HDL and/or high TG plasma levels). The secondary objectives are to evaluate specific metabolic parameters, visceral fat (in selected sites), safety and tolerability of rimonabant 20 mg.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Rimonabant

Criteria

Inclusion Criteria:

• Male or female patients aged >= 18 years

• Waist circumference > 102 cm in men and > 88 cm in women

• Dyslipidemia consisting of:

• Triglyceridemia >= 1.5g/L (i.e. 1.69mmol/L) and ≤ 7.0g/L (i.e. 7.90mmol/L) AND/OR

• HDL cholesterol < 50mg/dL (1.29mmol/L) in women, < 40mg/dL (1.04mmol/L) in men

• If patient with type 2 diabetes are included they must be on a stable dose of oral antidiabetic medication (excluding glitazones) and should not be on insulin therapy

• Written informed consent

Exclusion Criteria:

• Weight change > 5 kg within 3 months prior to screening visit

• Pregnancy or lactation, or women planning to become pregnant

• Absence of medically approved contraceptive methods for females of childbearing potential

• Presence of any other condition (e.g. geographic, social…) actual or anticipated, that the Investigator feels that would restrict or limit the subject's participation for the duration of the study.

• Presence of any clinically significant endocrine disease (other than type 2 diabetes) according to the Investigator

• History of severe depression that could be defined as depression which necessitated the patient to be hospitalized, or patients with 2 or more recurrent episodes of depression or a history of suicide attempt.

• Presence or history of DSM-IV bulimia or anorexia nervosa- Positive test for hepatitis B surface antigen and/or hepatitis C antibody; Abnormal TSH level (TSH > ULN or < LLN ); Hemoglobin < 11g/dL and/or neutrophils > 1,500/mm3 and/or platelets < 100,000/mm3; Positive urine pregnancy test in females of childbearing potential.

• Within 3 months prior to screening visit and between the screening and the inclusion visit:

• Administration of anti obesity drugs (e.g., sibutramine, orlistat)

• Administration of other drugs for weight reduction including herbal preparations (phentermine, amphetamines)

• Thyroid preparations or thyroxine treatment (except in patients on replacement therapy on a stable dose)

• If patients with type 2 diabetes are included they must be on a stable dose of oral antidiabetic medication for at least 3 months and should not be expected to receive insulin therapy within 12 months: Insulin, Glitazones

• Any change in lipid lowering treatment (i.e. introduction of a new drug, change, cessation)- Administration of systemic long-acting corticosteroids- Prolonged use (more than 1 week) of systemic corticosteroids (or if daily dosage > 1000 µg equivalent beclomethasone

• Prolonged administration (more than one week) of antidepressants (including bupropion)

• Prolonged administration (more than one week) of neuroleptics.