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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 patients with generalized anxiety disorder.

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 patients with generalized anxiety disorder.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-003805-19-SE
Enrollment
360
Registered
2006-09-05
Start date
2006-11-06
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To evaluate the efficacy, safety and tolerability of a saredutant 100 mg dose once daily, in patients with generalized anxiety disorder.

Interventions

Product Name: saredutant succinate Product Code: SR48968C Pharmaceutical Form: Capsule, hard INN or Proposed INN: saredutant succinate CAS Number: 176381-98-9 Current Sponsor code: SR48968C Concentrat

Sponsors

sanofi-aventis recherche et développement
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Male or female patients. - At least 18 years of age. - Diagnosis of generalized anxiety disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) Plus Generalized Anxiety Disorder Module. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Minimum total score of less than 22 (<22) on the 14-item HAM-A Total score of 18 or higher (=18) on the Montgomery-Asberg Depression Rating Scale (MADRS)

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the efficacy of saredutant 100 mg once daily compared to placebo with escitalopram as an active control, in patients with generalized anxiety disorder (GAD), as assessed by a change from baseline to Visit 7 (Day 56) in the 14-item HAM-A total score.;Secondary Objective: - To evaluate the tolerability and safety of saredutant in patients with generalized anxiety disorder. - To evaluate the efficacy of saredutant compared to placebo on disability and quality of life in patients with generalized anxiety disorder. - To evaluate plasma concentrations of saredutant and SR49596 (inactive metabolite);Primary end point(s): The change from baseline to Day 56 in the 14-item HAM-A total score in the intent-to-treat (ITT) population.—

Countries

Finland, Italy, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026