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

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00239967

First received: October 13, 2005

Last updated: April 6, 2009

Last verified: April 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 13, 2005

Last Updated Date

April 6, 2009

Start Date ^ICMJE

May 2005

Primary Completion Date

February 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00239967 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Dyslipidemia
Obesity

Intervention ^ICMJE

Drug: Rimonabant (SR141716)
Drug: Placebo

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

803

Completion Date

February 2007

Primary Completion Date

February 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

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

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00239967

Other Study ID Numbers ^ICMJE

EFC5823

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

ICD Study Director, sanofi-aventis

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi

PRS Account

Sanofi

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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