Generalized Anxiety Disorder
Conditions
Interventions
Trade Name: Lyrica
Product Name: Pregabalin
Product Code: CI-1008
Pharmaceutical Form: Capsule*
Sponsors
Pfizer Global Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective : • To evaluate under open-label conditions the long-term safety and tolerability of pregabalin in doses ranging from 150 to 600 mg/day. ;Secondary Objective: • To enable patients who have participated in pregabalin efficacy studies in anxiety disorders to continue receiving pregabalin treatment on ethical grounds; • To evaluate under open-label conditions the effect of pregabalin on the severity of illness, following either continuation of pregabalin treatment or after switching from an active comparator or placebo in the previous efficacy study ;Primary end point(s): Clinical Global Impression of Severity score | — |
Countries
Latvia
Outcome results
None listed