- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00763438
Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia
November 7, 2016 updated by: H. Lundbeck A/S
A Prospective, Open-label, Single-arm, Multinational, Multi-centre, Flexible-dose, Extension Study of the SCoP 99824 With Sertindole for Patients Suffering From Schizophrenia
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Allonnes, France, 72703
- FR002
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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- Withdrawn before the end of the SCoP study, 99824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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sertindole
|
Flexible dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All serious adverse events reported; visits scheduled every 3 months
Time Frame: Every 3 months
|
Every 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
September 30, 2008
First Submitted That Met QC Criteria
September 30, 2008
First Posted (Estimate)
October 1, 2008
Study Record Updates
Last Update Posted (Estimate)
November 8, 2016
Last Update Submitted That Met QC Criteria
November 7, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12009A
- 2007.002160-10 (EudraCT Number)
Plan for Individual participant data (IPD)
Study Data/Documents
-
EMA EudraCT Results
Information identifier: 2007-002160-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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