A double-blind, multi-center, randomized withdrawal study evaluating the efficacy and safety of Amibegron 350 mg twice a day versus placebo in the prevention of relapse of anxiety up to 1 year in patients with Generalized Anxiety Disorder improved after 12 weeks of open treatment with Amibegron 350 mg twice a day - VEGA

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-002253-71-IT
• Date of registration: 06/12/2006
• Prospective Registration: No
• Primary sponsor: sanofi-aventis recherche de veloppement
• Public title: A double-blind, multi-center, randomized withdrawal study evaluating the efficacy and safety of Amibegron 350 mg twice a day versus placebo in the prevention of relapse of anxiety up to 1 year in patients with Generalized Anxiety Disorder improved after 12 weeks of open treatment with Amibegron 350 mg twice a day - VEGA
• Scientific title: A double-blind, multi-center, randomized withdrawal study evaluating the efficacy and safety of Amibegron 350 mg twice a day versus placebo in the prevention of relapse of anxiety up to 1 year in patients with Generalized Anxiety Disorder improved after 12 weeks of open treatment with Amibegron 350 mg twice a day - VEGA
• Date of first enrolment: 09/11/2006
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002253-71
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany, Hungary, Italy, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
For entry into the open phase Patients suffering from generalized anxiety disorder, according to Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR criteria and assessed with the Mini International Neuropsychiatric Interview MINI 7 plus GAD module with a total score on the 14-item Hamilton Anxiety Rating Scale HAM-A or equal to 20 at V1 D-4 and V2 D-1 . For entry into the double-blind randomized phase Improved patients with HAM-A score 11 at V7 W12
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:
Related to study methodology 1. Inpatients. 2. Patients legal age of majority. 3. Patients unable to give voluntarily their written informed consent to participate in the whole study or to comply with the protocol and follow written and verbal instructions. 4. Patients with a diagnosis of Major Depressive Disorder as defined by DSM IV-TR within 6 months of screening. 5. Patients with a Montgomery and Asberg Depression Rating Scale MADRS 9 total score 18 at screening Visit 1, Day -4 or baseline Visit 2, Day -1 . 6. Patients at immediate risk for suicidal behavior based on an unstructured clinical interview; or who have, before first study drug intake at either the screening V1 or baseline V2 visits A score of 5 on the suicidal thoughts item of the MADRS Or, a current suicide risk score or equal to 10 from module C of the MINI . 7. Patients with other current within 6 months anxiety disorder according to the MINI of Panic disorder, Agoraphobia, Social phobia, Obsessive compulsive disorder OCD , Post-traumatic stress disorder PTSD . 8. Patients with a lifetime history according to the MINI of Bipolar disorder, Psychotic disorder, Antisocial personality disorder. 9. Patients with a current history according to the MINI of Anorexia nervosa or bulimia nervosa in the past 6 months Alcohol dependence or abuse or substance dependence or abuse in the past 12 months, except nicotine or caffeine dependence. 10. Patients who have used the following medications prior to screening Any continuous use of anxiolytic e.g., benzodiazepines, buspirone or hypnotic e.g., zolpidem, zaleplon within 2 weeks. Chronic means more than 2 days per week. Any antipsychotic within 3 months, Any antidepressant within 4 weeks, Any mood-stabilizer lithium, anticonvulsants within 4 weeks. 11. Treatment with electroconvulsive therapy ECT or rapid Transcranial Magnetic Stimulation r TMS within 3 months prior to screening. 12. Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening. 13. Patients with severe or unstable concomitant medical conditions cardiovascular, neurological, gastrointestinal, hepatic, renal, endocrinologic, rhumatologic according to the investigator s judgment that would impact the assessment of the study drug. 14. History of seizures other than a single childhood febrile seizure. 15. Patients with clinically significant abnormal laboratory value at screening, e.g. ALT or AST 2 times upper limit of normal range ULN , hemoglobin 12g / 100ml for male and 11g / 100ml for female, neutrophils 1500/mm3, platelets 100 000/mm3, creatinine or egual to; 150 mol/l. 16. Patients with clinically significant ECG findings or positive results on the urine drug screen at screening. 17. Patients who have taken an investigational drug in the last 3 months prior to screening. 18. Any patient who has previously participated in a Amibegron protocol. 19. Females of childbearing potential with a positive beta-HCG pregnancy test at screening, or not using an effective method of birth control during the entire study period i.e. birth control pill, intrauterine device, hormonal injection, sterilization or barrier method plus spermicide and females pregnant or lactating


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

General Anxiety Disorder
MedDRA version: 8.1 Level: LLT Classification code 10018075 Term: Generalised anxiety disorder

Intervention(s)

Product Name: amibegron
Product Code: SR58611A
Pharmaceutical Form: Film-coated tablet
CAS Number: 121524-09-2
Current Sponsor code: SR58611A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 350-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To assess the efficacy of Amibegron 350 mg twice a day compared to placebo in the prevention of relapse of anxiety, in improved patients with generalized anxiety disorder GAD , over a 24 to 52-week treatment period.

Secondary Objective: To assess the efficacy of Amibegron on the secondary efficacy criteria. The secondary efficacy criteria will be the change from baseline V7 of Clinical Global Impression CGI Severity of Illness score. Hamilton Anxiety Rating Scale HAM-A . To assess the safety and tolerability of Amibegron in patients with generalized anxiety disorder. The safety criteria will be the following Vital signs including weight Spontaneously-reported adverse events Clinical laboratories Physician Withdrawal Checklist PWC Montgomery and Asberg depression rating scale MADRS .

Primary end point(s): The primary criterion is the time to relapse of anxious symptoms in days from randomization date defined by any one of the following criteria HAM-A total score or equal to 15 confirmed at a subsequent visit 2 weeks later unless the patient drops out, or Any drop-out for lack of efficacy according to investigator s decision based on his/her knowledge of the patient , or Prescription/use of alternative or additional treatments pharmacological or nonpharmacological for relief of psychiatric symptoms

Secondary ID(s)

2006-002253-71-ES

LTE5894 VEGA