NCT00390533 is a Phase 3 clinical trial of Saredutant in Generalized Anxiety, sponsored by Sanofi.

Who is sponsoring NCT00390533?

NCT00390533 is sponsored by Sanofi.

What drugs are being tested in NCT00390533?

Interventions in NCT00390533: Saredutant, Placebo.

What condition does NCT00390533 study?

NCT00390533 studies Generalized Anxiety.

Is NCT00390533 still recruiting?

NCT00390533 is currently completed. Last updated 25 April 2016.

Last reviewed 2016-04-25 · How we verify

NCT00390533

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Eight-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study, to Evaluate the Efficacy, Safety and Tolerability of Two Fixed Doses (100 and 30 mg Once Daily) of Saredutant in Patients With Generalized Anxiety Disorder

Completed Phase 3 Last updated 25 April 2016

What this trial tests

Phase 3 trial testing Saredutant in Generalized Anxiety in 428 participants. Completed in 1 February 2008.

Timeline

1 September 2006

Primary endpoint
1 February 2008

1 February 2008

Quick facts

Lead sponsor	Sanofi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	428
Start date	1 September 2006
Primary completion	1 February 2008
Estimated completion	1 February 2008
Sites	2 locations across United States, Australia

Drugs / interventions tested

Saredutant — full drug profile →
Placebo

Conditions studied

Generalized Anxiety — all drugs for Generalized Anxiety →

Sponsor

Sanofi — full company profile →

Who can join

18 and older, any sex, with Generalized Anxiety. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.
Time frame: 56 days

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Generalized Anxiety

Currently open trials in the same condition.

NCT06934525 — Implementing Team-Based Treatment for Pediatric Anxiety in Community Mental Health Settings · NA · recruiting
NCT07189715 — Optimization of Imagery Rescripting Research Using Generative Artificial Intelligence · NA · recruiting
NCT06973577 — P3b Short-term Study of CTN in Patients With ADHD and Comorbid Anxiety · Phase 3 · active not recruiting
NCT04751864 — Brain Stimulation & Generalized Anxiety Study · Phase 4 · active not recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00390533 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 25 April 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00390533.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing