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

Obesity Clinical Trial

— ADAGIO-lipids  

Official title:

A Randomized, Double-Blind, Two-Arm Placebo-Controlled, Parallel-Group, Multicenter Study of Rimonabant 20 mg Once Daily in the Treatment of Atherogenic Dyslipidemia in Abdominally Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239967
• Other study ID #: EFC5823
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2005
• Last updated: April 6, 2009
• Start date: May 2005
• Est. completion date: February 2007

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 803
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Obesity

Intervention

Drug:
• Rimonabant (SR141716)

• Placebo

Locations

Country	Name	City	State
Australia	Sanofi-aventis Administrative Office	Macquarie Park
Brazil	Sanofi-aventis Administrative Office	Sao Paulo
Canada	Sanofi-aventis Administrative Office	Laval
Denmark	Sanofi-aventis Administrative Office	Horsholm
Hong Kong	Sanofi-aventis Administrative Office	Causeway Bay
Italy	Sanofi-aventis Administrative Office	Milano
Korea, Republic of	Sanofi-aventis Administrative Office	Seoul
Malaysia	Sanofi-aventis Administrative Office	Kuala Lumpur
Mexico	Sanofi-aventis Administrative Office	Mexico
Singapore	Sanofi-aventis Administrative Office	Singapore
South Africa	Sanofi-aventis Administrative Office	Midrand
Sweden	Sanofi-aventis Administrative Office	Bromma
Taiwan	Sanofi-aventis Administrative Office	Taipei
United States	Sanofi-aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HDL cholesterol and TG plasma levels over a period of one year.
Secondary	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