Clinical trial NCT00239967: An International Study of Rimonabant in Dyslipidemia With AtheroGenic Risk In Abdominally Obese Patients
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia
Obesity
Keywords: dyslipidemia
obesity
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 803
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: HDL cholesterol and TG plasma levels over a period of one year.
Secondary outcomes:
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
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-aventis Administrative Office
state: New Jersey
city: Macquarie Park
country: Australia
facility: Sanofi-aventis Administrative Office
city: Sao Paulo
country: Brazil
facility: Sanofi-aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-aventis Administrative Office
city: Horsholm
country: Denmark
facility: Sanofi-aventis Administrative Office
city: Causeway Bay
country: Hong Kong
facility: Sanofi-aventis Administrative Office
city: Milano
country: Italy
facility: Sanofi-aventis Administrative Office
city: Seoul
country: Korea, Republic of
facility: Sanofi-aventis Administrative Office
city: Kuala Lumpur
country: Malaysia
facility: Sanofi-aventis Administrative Office
city: Mexico
country: Mexico
facility: Sanofi-aventis Administrative Office
city: Singapore
country: Singapore
facility: Sanofi-aventis Administrative Office
city: Midrand
country: South Africa
facility: Sanofi-aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-aventis Administrative Office
city: Taipei
country: Taiwan
facility: Sanofi-aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: