General Information
Shire Schizophrenia 335
A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 26-week, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 Low Dose Range (40mg, 80mg, 100mg) and High Dose Range (120mg, 140mg, 160mg) as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults who have Persistent Predominant Negative Symptoms of Schizophrenia.
| Protocol | |
|---|---|
| Identifier | SPD489-335 |
| UID | a5bceffd-9899-4343-8144-dde2de00ff90 |
| Status | Cancelled |
| Phase | 3 |
| Category | Schizophrenia |
| Launch Year | 0 |
| NCT Number | - |
| Created | 2013-01-08 14:36 |
| Last Updated | 2013-01-08 14:36 |
Description
No description provided.
Comment
No comment.
Target Dates
| Name | Date | Required |
|---|---|---|
| Enrollment Closed | No | |
| Enrollment Open | No | |
| First Patient First Visit | No | |
| Site Initiation Mtg. | No | |
| PI Meeting Start | No | |
| PI Meeting End | No | |
| PI Meeting Arrival | No | |
| PI Meeting Departure | No | |
| Closeout Date | No | |
| Final PatientVisit | No | |
| PreStudy Selection Visit | No | |
| Target Date 12 | No | |
| Target Date 13 | No | |
| Target Date 14 | No |
Leadership
| Role | Staff | Login | Required |
|---|---|---|---|
| Principal | Mohaupt, Stephen | SMohaupt | No |
| Recruiter | - | No | |
| Coordinator | Barnett, Omar | OBarnett | No |
| Regulatory | - | No |
Custom Fields
No custom fields.
Sponsor & Organization
| Sponsor | Shire Development, Inc. |
|---|---|
| Division | Shire Development, Inc. |
| Team | Shire Development, Inc. |
| Managing Site | Catalina Research Institute, LLC |
| Organization |
Contacts
| IRB Ref | INC1-12-461 |
|---|---|
| CRO | Inc Research, LLC |
| CRO Ref | |
| Correspondence | 0 |
Opportunity
| Probability | 0 |
|---|---|
| Comment | |
| Status Color | Yellow |
| Currency | - |
