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Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia

NCT ID: NCT00763438

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia

Keywords

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Schizophrenia Sertindole Safety study

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sertindole

Group Type EXPERIMENTAL

Sertindole

Intervention Type DRUG

Flexible dose

Interventions

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Sertindole

Flexible dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

Locations

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FR002

Allonnes, , France

Site Status

Countries

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France

Study Documents

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Document Type: EMA EudraCT Results

View Document

Other Identifiers

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2007.002160-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12009A

Identifier Type: -

Identifier Source: org_study_id

NCT00563550

Identifier Type: -

Identifier Source: nct_alias