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

April 6, 2009 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

803

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Macquarie Park, Australia
        • Sanofi-Aventis Administrative Office
  • Brazil
      • Sao Paulo, Brazil
        • Sanofi-Aventis Administrative Office
  • Canada
      • Laval, Canada
        • Sanofi-Aventis Administrative Office
  • Denmark
      • Horsholm, Denmark
        • Sanofi-Aventis Administrative Office
  • Hong Kong
      • Causeway Bay, Hong Kong
        • Sanofi-Aventis Administrative Office
  • Italy
      • Milano, Italy
        • Sanofi-Aventis Administrative Office
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Sanofi-Aventis Administrative Office
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Sanofi-Aventis Administrative Office
  • Mexico
      • Mexico, Mexico
        • Sanofi-Aventis Administrative Office
  • Singapore
      • Singapore, Singapore
        • Sanofi-Aventis Administrative Office
  • South Africa
      • Midrand, South Africa
        • Sanofi-Aventis Administrative Office
  • Sweden
      • Bromma, Sweden
        • Sanofi-Aventis Administrative Office
  • Taiwan
      • Taipei, Taiwan
        • Sanofi-Aventis Administrative Office
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HDL cholesterol and TG plasma levels over a period of one year.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

October 13, 2005

First Submitted That Met QC Criteria

October 13, 2005

First Posted (Estimate)

October 17, 2005

Study Record Updates

Last Update Posted (Estimate)

April 7, 2009

Last Update Submitted That Met QC Criteria

April 6, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC5823

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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