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

NCT00458081 | Terminated Phase 3

• 2 other identifiers: RIMON_L_01031EudraCT # : 2006-002951-33
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity; Microalbuminuria; Diabetes Mellitus, Type 2; Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Relative change in the microalbuminuria level.

  between baseline visit and Month 12

Secondary Outcomes (4)

• 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

Study Arms (2)

Rimonabant

EXPERIMENTAL

Drug: Rimonabant

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rimonabant DRUG

20 mg once per day + slightly reduced calorie diet

Rimonabant

Placebo DRUG

placebo once per day + slightly reduced calorie diet

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Barcelona, Spain

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Dyslipidemias

Interventions

Rimonabant

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Officials

• José Mª Taboada

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 6, 2007
• First Posted: April 9, 2007
• Study Start: March 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 10, 2010

Record last verified: 2010-12

Locations

ES (1)