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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 )
First Received: April 6, 2007   Last Updated: February 27, 2009   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00458081
  Purpose

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

Condition Intervention Phase
Obesity
Microalbuminuria
Diabetes Mellitus, Type 2
Dyslipidemia
Drug: Rimonabant
Drug: Placebo
Phase III

MedlinePlus related topics: Diabetes Obesity
Drug Information available for: SR 141716A Rimonabant
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Relative change in the microalbuminuria level. [ Time Frame: between baseline visit and Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 174
Study Start Date: March 2007
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Rimonabant: Experimental Drug: Rimonabant
20 mg once per day + slightly reduced calorie diet
Placebo: Placebo Comparator Drug: Placebo
placebo once per day + slightly reduced calorie diet

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458081

Locations
Spain
Sanofi-Aventis
Barcelona, Spain
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: José Mª Taboada Sanofi-Aventis
  More Information

No publications provided

Responsible Party: sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers: RIMON_L_01031, EudraCT # : 2006-002951-33
Study First Received: April 6, 2007
Last Updated: February 27, 2009
ClinicalTrials.gov Identifier: NCT00458081     History of Changes
Health Authority: Spain: Spanish Agency of Medicines

Study placed in the following topic categories:
Obesity
Albuminuria
Metabolic Diseases
Urination Disorders
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms
Proteinuria
Urologic Diseases
Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Obesity
Albuminuria
Metabolic Diseases
Urination Disorders
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Urological Manifestations
Signs and Symptoms
Proteinuria
Urologic Diseases
Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Glucose Metabolism Disorders
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009