NCT00239967|CompletedPhase 3

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

ADAGIO-lipids

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

Sanofi ClinicalTrials.gov

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1 other identifier

EFC5823

Study Type

interventional

Target

803

Locations

14 countries

Sites

Timeline

RegisteredOct 2005

StartedMay 2005

CompletionFeb 2007

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

803

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started May 2005

Geographic Reach

14 countries

14 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

Study Start

First participant enrolled

May 1, 2005

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed

Last Updated

April 7, 2009

Status Verified

April 1, 2009

Enrollment Period

1.8 years

First QC Date

October 13, 2005

Last Update Submit

April 6, 2009

Conditions

Dyslipidemia Obesity

Keywords

dyslipidemiaobesity

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Rimonabant (SR141716)DRUG

PlaceboDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.
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.

Contact the study team to confirm eligibility.