Status:
COMPLETED
An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients
Lead Sponsor:
Sanofi
Conditions:
Dyslipidemia
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
803 Patients enrolled
Trial Details
Trial ID
NCT00239967
Start Date
May 1 2005
End Date
February 1 2007
Last Update
April 7 2009
Active Locations (14)
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1
Sanofi-aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-aventis Administrative Office
Macquarie Park, Australia
3
Sanofi-aventis Administrative Office
São Paulo, Brazil
4
Sanofi-aventis Administrative Office
Laval, Canada