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

Primary Purpose

Dyslipidemia, Obesity

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rimonabant (SR141716)
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring dyslipidemia, obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office
  • Sanofi-aventis Administrative Office

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 13, 2005
Last Updated
April 6, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00239967
Brief Title
An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Obesity
Keywords
dyslipidemia, obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
803 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rimonabant (SR141716)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
HDL cholesterol and TG plasma levels over a period of one year.
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-aventis Administrative Office
City
Macquarie Park
Country
Australia
Facility Name
Sanofi-aventis Administrative Office
City
Sao Paulo
Country
Brazil
Facility Name
Sanofi-aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-aventis Administrative Office
City
Horsholm
Country
Denmark
Facility Name
Sanofi-aventis Administrative Office
City
Causeway Bay
Country
Hong Kong
Facility Name
Sanofi-aventis Administrative Office
City
Milano
Country
Italy
Facility Name
Sanofi-aventis Administrative Office
City
Seoul
Country
Korea, Republic of
Facility Name
Sanofi-aventis Administrative Office
City
Kuala Lumpur
Country
Malaysia
Facility Name
Sanofi-aventis Administrative Office
City
Mexico
Country
Mexico
Facility Name
Sanofi-aventis Administrative Office
City
Singapore
Country
Singapore
Facility Name
Sanofi-aventis Administrative Office
City
Midrand
Country
South Africa
Facility Name
Sanofi-aventis Administrative Office
City
Bromma
Country
Sweden
Facility Name
Sanofi-aventis Administrative Office
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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