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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 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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 254 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,202-participant average among 102 other Metabolic Syndrome trials with a reported enrollment target (79% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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 reports 9 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.