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

This study has been terminated.
(Company decision has been taken in light of recent demands by certain national health authorities)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00458081
First received: April 6, 2007
Last updated: December 9, 2010
Last verified: December 2010

April 6, 2007
December 9, 2010
March 2007
January 2009   (final data collection date for primary outcome measure)
Relative change in the microalbuminuria level. [ Time Frame: between baseline visit and Month 12 ] [ Designated as safety issue: No ]
Relative change between baseline and Month 12 in the microalbuminuria level.
Complete list of historical versions of study NCT00458081 on ClinicalTrials.gov Archive Site
  • Percentage of patients whose albuminuria levels decrease, stabilise, are progressing towards macroalbuminuria, are unaltered. [ Time Frame: between baseline visit and Month 12 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: between baseline visit and Month 12 ] [ Designated as safety issue: No ]
  • Evaluation of the Quality of Life (questionnaire IWQOL). [ Time Frame: at baseline visit and at 3, 6 and 12 months visit ] [ Designated as safety issue: No ]
  • Safety (including neuropsychiatric events) and Laboratory assessments. [ Time Frame: at each visit and at baseline, 3, 6 and 12 month visits ] [ Designated as safety issue: Yes ]
  • Percentage of patients whose albuminuria levels between the baseline visit and Month 12 decrease, stabilise, are progressing towards macroalbuminuria, are unaltered.
  • Relative change and absolute change between baseline and Month 12 of Weight, Waist circumference
  • Body mass index (weight and height), Specific lipid parameters
  • Glycaemia control parameters ; Proinflammatory markers
  • Adipocytokines; Glomerular filtration rate; Blood pressure
  • Evaluation of the Quality of Life (questionnaire IWQOL).
  • Safety (including neuropsychiatric events) and Laboratory assessments.
Not Provided
Not Provided
 
Evaluation of the Rimonabant Impact on the Regression of Asymptomatic Damage Caused by Cardiovascular Risk Factors
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.

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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Obesity
  • Microalbuminuria
  • Diabetes Mellitus, Type 2
  • Dyslipidemia
  • Drug: Rimonabant
    20 mg once per day + slightly reduced calorie diet
  • Drug: Placebo
    placebo once per day + slightly reduced calorie diet
  • Experimental: Rimonabant
    Intervention: Drug: Rimonabant
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
174
January 2009
January 2009   (final data collection date for primary outcome measure)

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.

Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00458081
RIMON_L_01031, EudraCT # : 2006-002951-33
No
Trial Transparency Team, sanofi-aventis
Sanofi
Not Provided
Study Director: José Mª Taboada Sanofi
Sanofi
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP