Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01150448 | A Safety and Pharmacokinetic Study of Paliperidone Palmitate in Patients With Schizophrenia | PHASE1 | COMPLETED | 212 | — | — | Sep 1, 2007 | Jun 1, 2009 | May 28, 2014 | 28 | United States, Belgium +8 |
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | Paliperidone palmitate Treatment A All patients will receive a single IM injection of 150mg eq of study drug on Day 1. Patients who tolerate 150mg eq will receive a 2nd IM injection of 150mg eq on Day 8 followed by 12 IM injections (1 every 4 weeks) of 150mg eq. All other patients will be assigned to Treatment B. |
| 002 | EXPERIMENTAL | Paliperidone palmitate Treatment B Patients not tolerating Treatment A will receive a single IM injection of study drug 100mg eq at their next scheduled visit followed by injections (1 every 4 weeks) ranging from 50 to 150mg eq patients who do not wish to have multiple blood samples collected will also be assigned to Treatment B |
| Name | Type | Description |
|---|---|---|
| Paliperidone palmitate Treatment A | DRUG | All patients will receive a single IM injection of 150mg eq of study drug on Day 1. Patients who tolerate 150mg eq will receive a 2nd IM injection of 150mg eq on Day 8 followed by 12 IM injections (1 every 4 weeks) of 150mg eq. All other patients will be assigned to Treatment B. |
| Paliperidone palmitate Treatment B | DRUG | Patients not tolerating Treatment A will receive a single IM injection of study drug 100mg eq at their next scheduled visit followed by injections (1 every 4 weeks) ranging from 50 to 150mg eq |
Inclusion Criteria: * Meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for at least 1 year before screening * Have a body mass index (BMI) of \>=17.0 kg/m2 at screening * Have a Positive and Negative Syndr...