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

NCT00458081 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2010-12-10

No results posted yet for this study

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

Interventions

DRUG

Rimonabant

20 mg once per day + slightly reduced calorie diet

DRUG

Placebo

placebo once per day + slightly reduced calorie diet

Sponsors & Collaborators

Principal Investigators

  • José Mª Taboada · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00458081 on ClinicalTrials.gov