Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00299325 · ClinicalTrials.gov registry record · Phase 3
VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt
A Phase 3 study of Metabolic Syndrome, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 254
- Enrollment target
- 9
- Study locations
NCT00299325: Completed Phase 3 study of Metabolic Syndrome, sponsored by Sanofi.
NCT00299325 is a Phase 3 study of Metabolic Syndrome that has completed, run by Sanofi. The registered enrollment target is 254 participants, below the 1,202-participant average among 102 other Metabolic Syndrome trials with a reported enrollment target (79% lower). The trial reports 9 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00299325, a Phase 3 study of Metabolic Syndrome, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 254 participants
- Enrollment target
- 9
- Study locations
Study Summary
Primary objective: To assess the effect of rimonabant on visceral fat area over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with metabolic syndrome Secondary objectives: * To assess the effect of rimonabant over a period of 12 months on: * Liver fat content using CT scan (Computed Tomography scan) * Anthropometric measures (weight, waist circumference, body composition using Dual Energy X-ray Absorptiometry (DEXA)) * Lipid, lipoprotein profile * Glycemia, insulinemia and HbA1c * Adipokines, inflammatory and hemostatic markers * To evaluate the percentage of patients with metabolic syndrome at 12 months * To evaluate the safety and tolerability of rimonabant in these patients In four selected US sites the effect of rimonabant at 12 months will be also assessed on: * Basal lipolysis and insulin suppressed lipolysis (euglycemic hyperinsulinemic clamp). * Resting metabolic rate and substrate oxidation at rest using indirect calorimetry. * Adipose tissue histology and expression of genes involved in glucose and lipid metabolism (superficial adipose tissue biopsy).
Conditions Studied
Interventions
- DRUG Rimonabant
- DRUG Placebo (for Rimonabant)
- OTHER Mild hypocaloric diet
Study Locations (9)
Other
- Sanofi-Aventis Administrative Office - Laval
- Sanofi-Aventis Administrative Office - Hoersholm
- Sanofi-Aventis Administrative Office - Helsinki
- Sanofi-Aventis Administrative Office - Paris
- Sanofi-Aventis Administrative Office - Milan
- Sanofi-Aventis Administrative Office - Barcelona
- Sanofi-Aventis Administrative Office - Stockholm
- Sanofi-Aventis Administrative Office - Guildford
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2006-02 |
| Est. Completion | 2008-07 |
| Phase | Phase 3 |
What the finished NCT00299325 record still lists
NCT00299325 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, below the 1,202-participant average among 102 other Metabolic Syndrome trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Metabolic Syndrome appearing as the primary indexed condition, and to 3 interventions - of which Rimonabant is the first listed.
NCT00299325 lists 9 locations in 2 states (Other, New Jersey).
Frequently Asked Questions
What is clinical trial NCT00299325 about?
NCT00299325 is a clinical study titled "VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt". Primary objective: To assess the effect of rimonabant on visceral fat area over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with metabolic syndrome Secondary objectives: * To assess the effect of rimonabant over a period of 12 months on: * L...
What is the current status of trial NCT00299325?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 254 participants. The study started on 2006-02. Estimated completion is 2008-07.
What conditions does trial NCT00299325 study?
This clinical trial studies the following conditions: Metabolic Syndrome.
What interventions are being tested in trial NCT00299325?
The interventions under investigation include: Rimonabant (DRUG), Placebo (for Rimonabant) (DRUG), Mild hypocaloric diet (OTHER).
Who is sponsoring clinical trial NCT00299325?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00299325 being conducted?
This trial has 9 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metabolic Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00299325's enrollment target sits among peer trials
254 18th of 102 higher than 85 of 102 other Metabolic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metabolic Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Metabolic Adaptations to Weight Loss With and Without Exercise
RECRUITING · NA
-
Animal and Plant Proteins and Glucose Metabolism
RECRUITING · NA
-
Combined Oral Contraceptive Pill and Resistance Starch
RECRUITING · Phase 2
-
VR Stimulation of Exercise Response in Sedentary Humans
RECRUITING · NA
-
Impact of Supplemental Fiber on Gut and Vascular Health Related in Obesity Phenotypes
RECRUITING · NA
-
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04390737 · 254 participants · Phase 1
Evaluate the Safety and Clinical Activity of HH2853
- NCT04677647 · 254 participants · NA
OurChild: A Health IT Solution to Reduce Minority Health Disparities
- NCT05503797 · 254 participants · Phase 2
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
- NCT06167317 · 254 participants · Phase 1
Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia