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NCT00386061 · ClinicalTrials.gov registry record · Phase 3

Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
1,507
Enrollment target

NCT00386061: Completed Phase 3 study, sponsored by Sanofi.

NCT00386061 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 1,507 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00386061, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
1,507 participants
Enrollment target

Study Summary

The primary objective was to assess the effect of SR141716 on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with or without comorbidities. The main secondary objectives were to assess the effect of SR141716 on lipid parameters (HDL-C, TG), glucose tolerance status, the rate of patients with metabolic syndrome, waist circumference, glycemic parameters.

Interventions

  • DRUG rimonabant (SR141716)

Trial Details

FieldValue
Enrollment Target 1,507 participants
Start Date 2001-10
Est. Completion 2004-06
Phase Phase 3
Sanofi

713 total trials

What the finished NCT00386061 record still lists

NCT00386061 is an interventional study that assigns participants to a tested intervention. Its 1,507 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% higher).

The record links to 0 conditions, and to 1 intervention - of which rimonabant (SR141716) is the first listed.

NCT00386061 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00386061 about?

NCT00386061 is a clinical study titled "Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)". The primary objective was to assess the effect of SR141716 on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with or without comorbidities. The main secondary objectives were to assess the effect of SR141716 on lipid parameters...

What is the current status of trial NCT00386061?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,507 participants. The study started on 2001-10. Estimated completion is 2004-06.

What interventions are being tested in trial NCT00386061?

The interventions under investigation include: rimonabant (SR141716) (DRUG).

Who is sponsoring clinical trial NCT00386061?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00386061's enrollment target sits among peer trials

1,507 157th of 2000 higher than 1,844 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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

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Source: ClinicalTrials.gov NCT00386061, the US trial registry maintained by the National Library of Medicine. NCT00386061 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.