RIALTO: Evaluation of the Rimonabant Impact on the Regression of Asymptomatic Damage Caused by Cardiovascular Risk Factors
Study Details
Study Description
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:
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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.
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To assess the effect of treatment with rimonabant 20 mg versus placebo over a 12 month period on:
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Weight and waist circumference.
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Glycaemia profile: fasting glycaemia, fasting insulinaemia and HbA1c.
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Lipid and lipoprotein profile: triglycerides, total cholesterol, HDL-C, LDL-C, apolipoproteins A1 and B.
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Inflammatory markers
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Adipocytokines.
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Blood pressure.
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Glomerular filtration rate.
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To assess the quality of life by means of questionnaire filled in.
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Safety parameters
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Rimonabant
|
Drug: Rimonabant
20 mg once per day + slightly reduced calorie diet
|
| Placebo Comparator: Placebo
|
Drug: Placebo
placebo once per day + slightly reduced calorie diet
|
Outcome Measures
Primary Outcome Measures
- Relative change in the microalbuminuria level. [between baseline visit and Month 12]
Secondary Outcome Measures
- Percentage of patients whose albuminuria levels decrease, stabilise, are progressing towards macroalbuminuria, are unaltered. [between baseline visit and Month 12]
- Relative change and absolute change of Weight, Waist circumference, Body mass index (weight and height), Specific lipid parameters, Glycaemia control parameters, Proinflammatory markers, Adipocytokines, Glomerular filtration rate, Blood pressure [between baseline visit and Month 12]
- Evaluation of the Quality of Life (questionnaire IWQOL). [at baseline visit and at 3, 6 and 12 months visit]
- Safety (including neuropsychiatric events) and Laboratory assessments. [at each visit and at baseline, 3, 6 and 12 month visits]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Body Mass Index > 27 kg/m2 and < 40 kg/m2.
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Waist circumference > 102 cm in men and > 88 cm in women.
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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.
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Type 2 diabetes and/or dyslipidaemia.
Exclusion Criteria:
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Breastfeeding or pregnant women or who expect to become pregnant.
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Non-use of approved methods of contraception in women of child-bearing potential.
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History of very low calorie diet in the 3 months prior to the screening visit (<1200 kcal/day).
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Change in weight > 5 kg in the 3 months prior to the screening visit.
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History of surgery for weight loss (such as vertical banded gastroplasty, gastric by-pass, etc.)
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History of bulimia or anorexia nervosa according to DSM-IV definition.
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Any clinically significant endocrine disorder, in the opinion of the investigator, especially known alterations in the blood concentration of TSH and free T4.
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Type 1 Diabetes
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Triglyceridaemia > 400 mg/dl (4.52 mmol/l)
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Severe renal dysfunction
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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.
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Hypertension at the screening visit.
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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.
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History of abuse of alcohol or other substances (except smoking).
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Hypersensitivity or intolerance to the active ingredient or any of the excipients, such as lactose.
Concomitant medication prior to the screening visit
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Administration of any treatment undergoing clinical investigation (drug or medical device) in the 30 days prior to the screening visit.
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Previous treatment with rimonabant.
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Administration of any of the following products in the 3 months prior to the screening visit
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Anti-obesity drugs (such as, sibutramine or orlistat).
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Other weight loss drugs (phentermine,amphetamines).
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Weight loss herbal preparations.
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Nicotinic acid, fibrates, bile acid sequestrants or Omega 3 drugs (e.g. Omacor).
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Prolonged use (more than a week) of systemic corticosteroids or neuroleptics
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Antidepressants (including bupropion)
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Insulin, thiazolidinediones, α-glucosidase inhibitors, meglitinides or any group of antidiabetic drugs (except combination of biguanides and sulfonylureas)
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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.
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Start of or change in treatment with antihypertensive drugs in the 12 weeks prior to the screening visit.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis Administrative Office | Barcelona | Spain |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: José Mª Taboada, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RIMON_L_01031
- EudraCT # : 2006-002951-33