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

NCT ID: NCT00239967

Last Updated: 2009-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 803 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2007-02-28

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.

Conditions

Dyslipidemia; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Rimonabant (SR141716)

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-aventis Administrative Office

Macquarie Park, , Australia

Sanofi-aventis Administrative Office

São Paulo, , Brazil

Sanofi-aventis Administrative Office

Laval, , Canada

Sanofi-aventis Administrative Office

Hørsholm, , Denmark

Sanofi-aventis Administrative Office

Causeway Bay, , Hong Kong

Sanofi-aventis Administrative Office

Milan, , Italy

Sanofi-aventis Administrative Office

Kuala Lumpur, , Malaysia

Sanofi-aventis Administrative Office

México, , Mexico

Sanofi-aventis Administrative Office

Singapore, , Singapore

Sanofi-aventis Administrative Office

Midrand, , South Africa

Sanofi-aventis Administrative Office

Seoul, , South Korea

Sanofi-aventis Administrative Office

Bromma, , Sweden

Sanofi-aventis Administrative Office

Taipei, , Taiwan

Countries

United States; Australia; Brazil; Canada; Denmark; Hong Kong; Italy; Malaysia; Mexico; Singapore; South Africa; South Korea; Sweden; Taiwan

Other Identifiers

EFC5823

Identifier Type: -

Identifier Source: org_study_id