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NCT00250614 · ClinicalTrials.gov registry record · Phase 3

An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression

A Phase 3 study, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
452
Enrollment target

NCT00250614: Completed Phase 3 study, sponsored by Sanofi.

NCT00250614 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 452 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00250614, a Phase 3 study, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
452 participants
Enrollment target

Study Summary

The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C) in patients with depression. The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with depression. The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy of saredutant on disability and quality of life in patients with depression, and to evaluate blood levels of saredutant.

Interventions

  • DRUG Saredutant succinate (SR48968C)

Trial Details

FieldValue
Enrollment Target 452 participants
Start Date 2005-04
Est. Completion 2006-10
Phase Phase 3
Sanofi

713 total trials

What the finished NCT00250614 record still lists

NCT00250614 is an interventional study that assigns participants to a tested intervention. The registered 452 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower).

The record links to 0 conditions, and to 1 intervention - of which Saredutant succinate (SR48968C) is the first listed.

NCT00250614 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00250614 about?

NCT00250614 is a clinical study titled "An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression". The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C) in patients with depression. The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with depression. The secondary objectives are to evaluate the sa...

What is the current status of trial NCT00250614?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 452 participants. The study started on 2005-04. Estimated completion is 2006-10.

What interventions are being tested in trial NCT00250614?

The interventions under investigation include: Saredutant succinate (SR48968C) (DRUG).

Who is sponsoring clinical trial NCT00250614?

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

How this trial's enrollment target compares

Where NCT00250614's enrollment target sits among peer trials

452 835th of 2000 higher than 1,165 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 NCT00250614, the US trial registry maintained by the National Library of Medicine. NCT00250614 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.