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Also known as imagabalin
PD-0332334 · 4 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| PD 0332334 300 mg BID | EXPERIMENTAL | - |
| Placebo BID | PLACEBO_COMPARATOR | - |
| PD 0332334 225 mg BID | EXPERIMENTAL | - |
| PD 0332334 175 mg BID | EXPERIMENTAL | - |
| PD 0332334 250 mg | EXPERIMENTAL | - |
| PD 0332334 100 mg | EXPERIMENTAL | - |
| placebo | PLACEBO_COMPARATOR | - |
| Alprazolam extended release | ACTIVE_COMPARATOR | - |
| PD-0332334 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PD 0332334 | DRUG | Capsules, oral, 300 mg BID, 8 weeks with 2 week taper. |
| Placebo | DRUG | Capsules, oral, placebo BID, 8 weeks with 2 week taper. |
| Alprazolam extended release | DRUG | 1 mg capsule, BID for 4 weeks |
| PD-0332334 | DRUG | A single, 50 mg oral dose (2 capsules) of PD-0332334 will be administered to each hemodialysis subject |
Inclusion Criteria: * Diagnosis of GAD (Diagnostic and Statistical Manual-IV \[DSM-IV\], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MI...
PD-0332334 is an investigational small molecule developed by Pfizer, Inc. for Generalized Anxiety Disorder. It has also been studied in patients receiving renal dialysis for pharmacokinetic evaluation. The program reached Phase 3 clinical development, and all completed trials to date have been placebo-controlled, randomized, and double-blind.
PD-0332334 was studied for the treatment of Generalized Anxiety Disorder, with the largest trial enrolling 551 patients in a 10-week Phase 3 study. A separate Phase 1 study evaluated the drug in patients receiving regular hemodialysis. It is an investigational agent and has not been established as a marketed treatment.
PD-0332334 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical program, including the Phase 3 Generalized Anxiety Disorder trial and the Phase 1 hemodialysis and radiolabeled absorption studies.
PD-0332334 reached Phase 3 clinical development. The Phase 3 study, NCT00542685, was a 10-week trial evaluating efficacy and safety in Generalized Anxiety Disorder that enrolled 551 patients. All three completed trials in the program have concluded, and no trials are currently active.
PD-0332334 has been evaluated in completed trials including NCT00542685, a Phase 3 study in Generalized Anxiety Disorder with 551 patients, NCT00921063, a Phase 2 trial comparing PD 0332334 and alprazolam extended release to placebo in 222 patients, and NCT00730145, a Phase 1 hemodialysis study.
Yes, PD-0332334 and PD 0332334 refer to the same investigational compound. The difference is only formatting: one version uses a hyphen and the other uses a space. Both names appear in the registered clinical trial titles for the Pfizer Generalized Anxiety Disorder program.