Evaluation of the Rimonabant Impact on the Regression of Asymptomatic Damage Caused by Cardiovascular Risk Factors

• Status: Terminated
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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 both arms of the study whose levels of microalbuminuria decrease, stabilise, increase towards macroalbuminuria or are unchanged after 12 months of treatment with rimonabant or placebo.

• To assess the effect of treatment with rimonabant 20 mg versus placebo over a 12 month period on:

• Weight and waist circumference.

• Glycaemia profile: fasting glycaemia, fasting insulinaemia and HbA1c.

• Lipid and lipoprotein profile: triglycerides, total cholesterol, HDL-C, LDL-C, apolipoproteins A1 and B.

• Inflammatory markers

• Adipocytokines.

• Blood pressure.

• Glomerular filtration rate.

• To assess the quality of life by means of questionnaire filled in.

• Safety parameters

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Rimonabant

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.