A 1-Year Open-Label Safety Extension Study of Pregabalin (CI-1008) in Patients With Anxiety Disorders

Conditions: Generalized Anxiety Disorder

Registration Number: EUCTR2004-000954-22-LV

Lead Sponsor: Pfizer Global Research & Development

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 71

Inclusion Criteria

Patients may enroll from short-term efficacy studies of pregabalin in GAD (1008-087 or -152), social phobia (1008-081), or panic disorder (1008-091).
Patients enrolling from these prior short-term efficacy studies must:
•?Have completed the double-blind portion of the preceding trial and completed any protocol specified withdrawal phase and follow-up visits;
•?If female of childbearing age or potential, continue to use adequate birth control methods and have a negative serum pregnancy test at the preceding double-blind protocol termination or follow-up visit;
•?Be able to follow the investigator’s instructions and be able to comply with the visit schedule and visit requirements; and
•?Sign a written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

Patients may not participate in this study if:
•?They experienced a serious adverse event or a nonserious, but medically significant adverse event during the preceding efficacy study that was judged to be related to the study medication by the Investigator or the Parke-Davis Medical Monitor; or
•?They have an ongoing, unresolved, clinically significant medical problem that in the judgment of the investigator or the sponsor would make it unsafe for the patient to participate in the trial.