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An Eight-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Fixed Dose of SR58611A 350 mg Twice a Day in Elderly Patients with Generalized Anxiety Disorder with an Optional Twenty-Four week Extension - GEMINI

An Eight-Week, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Fixed Dose of SR58611A 350 mg Twice a Day in Elderly Patients with Generalized Anxiety Disorder with an Optional Twenty-Four week Extension - GEMINI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004147-33-FI
Enrollment
270
Registered
2006-12-21
Start date
2007-02-21
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

Generalized Anxiety Disorder

Interventions

Product Name: NA Product Code: SR58611 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: amibegron CAS Number: 121524-09-02 Current Sponsor code: SR58611A Other descriptive name: NA Concent

Sponsors

sanofi-aventis recherche & développement
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients diagnosed with Generalized Anxiety Disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision criteria diagnosed by a psychiatrist and supported 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Patients < 60 years of age • 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) • MMSE score of 22 or less (=22) • See protocol for a complete list of Exclusion Criteria

Design outcomes

Primary

MeasureTime frame
Main Objective: To demonstrate the efficacy of SR58611A 350 mg twice a day compared to placebo in elderly patients with Generalized Anxiety Disorder (GAD), as assessed by a change from baseline to Visit 7 (Day 56) in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score.;Secondary Objective: • To evaluate the tolerability and safety of SR58611A in elderly patients with generalized anxiety disorder • To evaluate the efficacy of SR58611A compared to placebo on disability and quality of life in elderly patients with generalized anxiety disorder • To evaluate the tolerability and safety of 24 weeks of additional treatment with SR58611A in elderly patients with generalized anxiety disorder;Primary end point(s): The primary efficacy criterion is the change from baseline in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score.—

Countries

Austria, Finland

Outcome results

None listed

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