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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)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00458081
First received: April 6, 2007
Last updated: December 9, 2010
Last verified: December 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

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
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00458081     History of Changes
Other Study ID Numbers: RIMON_L_01031, EudraCT # : 2006-002951-33
Study First Received: April 6, 2007
Last Updated: December 9, 2010
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Albuminuria
Diabetes Mellitus
Diabetes Mellitus, Type 2
Dyslipidemias
Obesity
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Lipid Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Proteinuria
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Rimonabant
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014