Status:
TERMINATED
Evaluation of the Rimonabant Impact on the Regression of Asymptomatic Damage Caused by Cardiovascular Risk Factors
Lead Sponsor:
Sanofi
Conditions:
Obesity
Microalbuminuria
Eligibility:
All Genders
30-75 years
Phase:
PHASE3
Brief Summary
Primary objective: * To assess the effect on microalbuminuria levels of treatment with rimonabant 20 mg versus a placebo during a 12 month period. Secondary objectives: * Percentage of patients in ...
Eligibility Criteria
Inclusion
- Body Mass Index \> 27 kg/m2 and \< 40 kg/m2.
- Waist circumference \> 102 cm in men and \> 88 cm in women.
- Microalbuminuria \>= 20 mg/g creatinine and \< 300 mg/g creatinine in at least two of three morning urine samples taken on 3 separate days prior to the baseline visit.
- Type 2 diabetes and/or dyslipidaemia.
Exclusion
- Breastfeeding or pregnant women or who expect to become pregnant.
- Non-use of approved methods of contraception in women of child-bearing potential.
- History of very low calorie diet in the 3 months prior to the screening visit (\<1200 kcal/day).
- Change in weight \> 5 kg in the 3 months prior to the screening visit.
- History of surgery for weight loss (such as vertical banded gastroplasty, gastric by-pass, etc.)
- History of bulimia or anorexia nervosa according to DSM-IV definition.
- Any clinically significant endocrine disorder, in the opinion of the investigator, especially known alterations in the blood concentration of TSH and free T4.
- Type 1 Diabetes
- Triglyceridaemia \> 400 mg/dl (4.52 mmol/l)
- Severe renal dysfunction
- Chronic Hepatitis or clinically known significant liver disease or ALT and/or AST \> 3x the upper limit of the normal range at the screening visit.
- Hypertension at the screening visit.
- Presence of any condition (medical, including clinically significant abnormal laboratory tests, physiological, social or geographical) actual or anticipated that the investigator feels would compromise the patient's safety or limit his/her successful participation to the study.
- History of abuse of alcohol or other substances (except smoking).
- Hypersensitivity or intolerance to the active ingredient or any of the excipients, such as lactose.
- Concomitant medication prior to the screening visit
- Administration of any treatment undergoing clinical investigation (drug or medical device) in the 30 days prior to the screening visit.
- Previous treatment with rimonabant.
- Administration of any of the following products in the 3 months prior to the screening visit
- Anti-obesity drugs (such as, sibutramine or orlistat).
- Other weight loss drugs (phentermine,amphetamines).
- Weight loss herbal preparations.
- Nicotinic acid, fibrates, bile acid sequestrants or Omega 3 drugs (e.g. Omacor).
- Prolonged use (more than a week) of systemic corticosteroids or neuroleptics
- Antidepressants (including bupropion)
- Insulin, thiazolidinediones, α-glucosidase inhibitors, meglitinides or any group of antidiabetic drugs (except combination of biguanides and sulfonylureas)
- In type 2 diabetes patients, start of or change in treatment with sulfonylureas and/or metformin, in the 4 weeks prior to the screening visit.
- Start of or change in treatment with antihypertensive drugs in the 12 weeks prior to the screening visit.
- Start of or change in treatment with statins and/or ezetimibe in the 8 weeks prior to the screening visit.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00458081
Start Date
March 1 2007
End Date
January 1 2009
Last Update
December 10 2010
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Barcelona, Spain