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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018410-78 | EudraCT Number |
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Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for eligibility for this 26-week extension study in which they will continue treatment. The primary purpose of this trial is to evaluate the long-term safety of asenapine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asenapine 5 mg | Experimental | Participants who were randomized to asenapine 5 mg twice per day (BID) during the P05691 study will be assigned to receive asenapine 5 mg BID on this extension study. Participant who were randomized to placebo during the P05691 study will be assigned to receive asenapine 5 mg BID on this extension trial. |
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| Asenapine 10 mg | Experimental | Participants who were randomized to asenapine 10 mg BID during the P05691 study will be assigned to receive asenapine 10 mg BID on this extension study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| asenapine | Drug | asenapine 5 mg tablet, sublingually (SL) twice daily (BID) for 182 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing clinical and laboratory adverse events (AEs) | Baseline up to 212 days |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 1000 | Austin | Texas | 78754 | United States |
| ID | Term |
|---|---|
| C522667 | asenapine |
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| asenapine | Drug | asenapine 10 mg tablet, SL BID for 182 days |
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