Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetes Mellitus, Type 2 Dyslipidemia Microalbuminuria Obesity

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

RimonabantDrug

20 mg once per day + slightly reduced calorie diet

Rimonabant

PlaceboDrug

placebo once per day + slightly reduced calorie diet

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age30 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Sanofi
Industrylead

Study Sites (1)

Sanofi-Aventis Administrative Office

Barcelona, Spain

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Dyslipidemias

Interventions

Rimonabant

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic Diseases

Study Officials

José Mª Taboada
Sanofi
STUDY DIRECTOR

Enrollment

174 participants (actual enrollment reported by the registry).

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 2007

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Rimonabant

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Rimonabant

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations