| ID | Type | Description | Link |
|---|---|---|---|
| 2007.002160-10 | EudraCT Number |
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The purpose of this study is to permit the patients with schizophrenia who received Sertindole during a previous randomised trial, study 99824, to continue with this treatment.
Schizophrenia is a disabling and often chronic disorder that may require long-term treatment. This protocol is an extension study of a randomised study comparing the safety of Sertindole versus Risperidone. Patients who were randomised to Sertindole and who completed the previous study have the possibility to receive continued Sertindole treatment in this open one-arm study. Sertindole is generally well tolerated and is approved in the EU, but not yet marketed in France. The follow-up of the patients will be similar to that in the previous study and requires quarterly visits. Patient management reflects routine clinical practice in accordance with the Sertindole label. Any severe safety issue is reported to the company.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertindole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertindole | Drug | Flexible dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| All serious adverse events reported; visits scheduled every 3 months | Every 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FR002 | Allonnes | 72703 | France |
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| ID | Type | URL | Comment |
|---|---|---|---|
| 2007-002160-10 | EMA EudraCT Results | View IPD |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C066304 | sertindole |
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