Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 21 November 2016
• Main ID: NCT00763438
• Date of registration: 30/09/2008
• Prospective Registration: No
• Primary sponsor: H. Lundbeck A/S
• Public title: Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia
• Scientific title: A Prospective, Open-label, Single-arm, Multinational, Multi-centre, Flexible-dose, Extension Study of the SCoP 99824 With Sertindole for Patients Suffering From Schizophrenia
• Date of first enrolment: November 2007
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00763438
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Email contact via H. Lundbeck A/S
• Affiliation: [e-mail]

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participation in the previous SCoP study, 99824

- Still fulfils the EU SPC requirements for Sertindole

Exclusion Criteria:

- Withdrawn before the end of the SCoP study, 99824

- Become homeless

- Participation in another clinical trial at the same time

- Unlikely to comply with the clinical study protocol or is unsuitable for any reason



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Sertindole

Primary Outcome(s)

All serious adverse events reported; visits scheduled every 3 months [Time Frame: Every 3 months]

Secondary ID(s)

2007.002160-10

12009A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors