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NCT00390533 · ClinicalTrials.gov registry record · Phase 3

An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder

A Phase 3 study of Generalized Anxiety, sponsored by Sanofi.

Completed
Registry status
Phase 3
Development phase
428
Enrollment target
2
Study locations

NCT00390533: Completed Phase 3 study of Generalized Anxiety, sponsored by Sanofi.

NCT00390533 is a Phase 3 study of Generalized Anxiety that has completed, run by Sanofi. The registered enrollment target is 428 participants, above the 320-participant average among 3 other Generalized Anxiety trials with a reported enrollment target (34% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00390533, a Phase 3 study of Generalized Anxiety, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 3
Development phase
428 participants
Enrollment target
2
Study locations

Study Summary

The primary objective is to evaluate the efficacy of two fixed doses (100 mg and 30 mg once daily) of saredutant compared to placebo in patients with generalized anxiety disorder. The secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with generalized anxiety disorder, and to evaluate blood levels of saredutant.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Saredutant

Study Locations (2)

New Jersey

  • Sanofi-Aventis Administrative Office - Bridgewater

Other

  • Sanofi-Aventis Administrative Office - Macquarie Park

Trial Details

FieldValue
Enrollment Target 428 participants
Start Date 2006-09
Est. Completion 2008-02
Phase Phase 3
Sanofi

713 total trials

What the finished NCT00390533 record still lists

NCT00390533 is an interventional study that assigns participants to a tested intervention. The registered 428 participants enrollment target is mid-sized for trials with a published cap, above the 320-participant average among 3 other Generalized Anxiety trials with a reported enrollment target (34% higher).

The record links to 1 condition, with Generalized Anxiety appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00390533 reports a single indexed study location in New Jersey, Other.

Frequently Asked Questions

What is clinical trial NCT00390533 about?

NCT00390533 is a clinical study titled "An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder". The primary objective is to evaluate the efficacy of two fixed doses (100 mg and 30 mg once daily) of saredutant compared to placebo in patients with generalized anxiety disorder. The secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with g...

What is the current status of trial NCT00390533?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 428 participants. The study started on 2006-09. Estimated completion is 2008-02.

What conditions does trial NCT00390533 study?

This clinical trial studies the following conditions: Generalized Anxiety.

What interventions are being tested in trial NCT00390533?

The interventions under investigation include: Placebo (DRUG), Saredutant (DRUG).

Who is sponsoring clinical trial NCT00390533?

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

Where is trial NCT00390533 being conducted?

This trial has 2 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00390533, the US trial registry maintained by the National Library of Medicine. NCT00390533 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.