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

NCT ID: NCT00458081

Last Updated: 2010-12-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-01-31

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 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

Conditions

Obesity; Microalbuminuria; Diabetes Mellitus, Type 2; Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Rimonabant

Group Type: EXPERIMENTAL

Rimonabant

Intervention Type: DRUG

20 mg once per day + slightly reduced calorie diet

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo once per day + slightly reduced calorie diet

Interventions

Rimonabant

20 mg once per day + slightly reduced calorie diet

Intervention Type: DRUG

Placebo

placebo once per day + slightly reduced calorie diet

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

José Mª Taboada

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Countries

Spain

Other Identifiers

EudraCT # : 2006-002951-33

Identifier Type: -

Identifier Source: secondary_id

RIMON_L_01031

Identifier Type: -

Identifier Source: org_study_id