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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 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.
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
| Field | Value |
|---|---|
| Enrollment Target | 428 participants |
| Start Date | 2006-09 |
| Est. Completion | 2008-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00390533
The ClinicalTrials.gov registry entry for NCT00390533 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 428 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 320-participant average among 3 other Generalized Anxiety trials with a reported enrollment target (34% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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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Related
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