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VIsceral Fat Reduction Assessed by CT-scan On RImonabAnt
NCT00299325 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00299325
The ClinicalTrials.gov registry entry for NCT00299325 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 254 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00299325 reports 9 study locations spanning 2 distinct geographic areas — top geographies include Other, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00299325?
The interventions under investigation include: Rimonabant (DRUG), Placebo (for Rimonabant) (DRUG), Mild hypocaloric diet (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00299325?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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