An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients
Phase 3
Completed
- Conditions
- DyslipidemiaObesity
- Registration Number
- NCT00239967
- Lead Sponsor
- Sanofi
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 803
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HDL cholesterol and TG plasma levels over a period of one year.
- Secondary Outcome Measures
Name Time Method Cholesterol content of HDL2 and HDL3 subfractions,HDL particle size,ApoB,ApoA1,ApoCIII, FFA, indeces of LDL size,hs-CRP,adipokines, fasting glycemia and insulinemia, HbA1c),waist and weight measurements,visceral fat measured by CT scan
Trial Locations
- Locations (1)
Sanofi-aventis Administrative Office
🇨🇳Taipei, Taiwan