NCT00415142 is a Phase 3 clinical trial of saredutant (SR48968) in Depressive Disorder, sponsored by Sanofi.

Who is sponsoring NCT00415142?

NCT00415142 is sponsored by Sanofi.

What drugs are being tested in NCT00415142?

Interventions in NCT00415142: saredutant (SR48968), placebo, escitalopram.

What condition does NCT00415142 study?

NCT00415142 studies Depressive Disorder.

Is NCT00415142 still recruiting?

NCT00415142 is currently completed. Last updated 25 April 2016.

Last reviewed 2016-04-25 · How we verify

NCT00415142

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

An Eight-week, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Study, With Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients With Major Depressive Disorder

Completed Phase 3 Last updated 25 April 2016

What this trial tests

Phase 3 trial testing saredutant (SR48968) in Depressive Disorder in 393 participants. Completed in 1 February 2008.

Timeline

1 December 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	393
Start date	1 December 2006
Primary completion	1 February 2008
Estimated completion	1 February 2008
Sites	8 locations across United States, Croatia, Czechia, France, Mexico, Russia, Sweden, Turkey (Türkiye)

Drugs / interventions tested

saredutant (SR48968) — full drug profile →
placebo
escitalopram (escitalopram) — full drug profile →

Conditions studied

Depressive Disorder — all drugs for Depressive Disorder →

Sponsor

Sanofi — full company profile →

Who can join

Adults 60 to 64, any sex, with Depressive Disorder. 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 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
Time frame: Day 56

Sponsor's own description

The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.

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:

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Other Sanofi trials

Trials by the same sponsor.

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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 NCT00415142 (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/NCT00415142.

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