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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00554619 | A Study to Evaluate GSK1325760A - a Long-Term Extension Study | PHASE3 | COMPLETED | 21 | — | — | Feb 1, 2008 | Jan 1, 2011 | Nov 5, 2012 | 11 | Japan |
An adverse event was defined as any untoward medical occurrence in a participant, temporally associated with the use of an investigational product, whether or not considered related to the investigational product.
The severity of adverse events was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.
| Arm | Type | Description |
|---|---|---|
| GSK1325760A | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GSK1325760A | DRUG | 2.5mg, 5mg or 10mg/day, po, GSK1325760A treatment will be continued until its approval by the MHLW. |
Inclusion Criteria: * Subjects who complete the 24-week administration of the Phase II/III study (Study No.AMB107816) * Subjects who are assessed that the long-term extension administration of GSK1325760A is appropriate in the judgement of the investigator or subinvestigator * Subjects who request ...