An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients (ADAGIO-lipids)

Sanofi

Status and phase

Completed

Phase 3

Conditions

Obesity

Dyslipidemia

Treatments

Drug: Rimonabant (SR141716)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00239967

EFC5823

Details and patient eligibility

About

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.

Enrollment

803 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.