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Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00763438
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Sertindole Phase 4

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Sertindole Drug: Sertindole
Flexible dose




Primary Outcome Measures :
  1. All serious adverse events reported; visits scheduled every 3 months [ Time Frame: Every 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763438


Locations
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France
FR002
Allonnes, France, 72703
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
Study Data/Documents: EMA EudraCT Results  This link exits the ClinicalTrials.gov site
Identifier: 2007-002160-10

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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00763438    
Obsolete Identifiers: NCT00563550
Other Study ID Numbers: 12009A
2007.002160-10 ( EudraCT Number )
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Keywords provided by H. Lundbeck A/S:
Schizophrenia
Sertindole
Safety study
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Sertindole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs