Clinical trial NCT00458081: Evaluation of the Rimonabant Impact on the Regression of Asymptomatic Damage Caused by Cardiovascular Risk Factors
Official title: A 12-month Multicentre, Randomised, Double-blind, Placebo-controlled Study With Two Parallel Groups to Assess the Effects of Rimonabant 20 mg in Patients With Abdominal Obesity and Microalbuminuria, With Type 2 Diabetes Mellitus or Dyslipidaemia With or Without Other Cardiometabolic Risk Factors.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obesity
Microalbuminuria
Diabetes Mellitus, Type 2
Dyslipidemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-04-09
Enrollment: 174
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Relative change in the microalbuminuria level.
timeFrame: between baseline visit and Month 12
Secondary outcomes:
measure: Percentage of patients whose albuminuria levels decrease, stabilise, are progressing towards macroalbuminuria, are unaltered.
timeFrame: between baseline visit and Month 12
measure: 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
timeFrame: between baseline visit and Month 12
measure: Evaluation of the Quality of Life (questionnaire IWQOL).
timeFrame: at baseline visit and at 3, 6 and 12 months visit
measure: Safety (including neuropsychiatric events) and Laboratory assessments.
timeFrame: at each visit and at baseline, 3, 6 and 12 month visits
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: José Mª Taboada
role: STUDY_DIRECTOR
References: