Status:
COMPLETED
Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to determine whether there is an increased all-cause mortality in sertindole-treated patients in comparison to patients treated with a well-known antipsychotic (risperidone...
Detailed Description
The Committee for Medicinal Products for Human Use (CHMP) requested a post-marketing study to ascertain that the favourable benefit-risk profile and low mortality rates seen in the clinical studies wi...
Eligibility Criteria
Inclusion
- The patient has signed the Informed Consent Form or, if he/she is not able to sign it (according to the ICH GCP guidelines and the Declaration of Helsinki), the patient's legal representative has signed the Informed Consent Form
- The patient has been diagnosed with schizophrenia
- Based on the patient's clinical status, new or change of antipsychotic treatment is indicated
- The patient is at least 18 years of age
- The patient meets the criteria set out in the national SPCs for sertindole and risperidone. For those countries in which sertindole was not marketed, the EU SPC applied
Exclusion
- The last treatment taken by the patient was sertindole or risperidone
- The patient has never previously received any antipsychotic drug therapy
- The patient has contraindications to treatment with either sertindole or risperidone
- In addition to sertindole/risperidone, treatment with another antipsychotic is indicated
- The patient is homeless
- The patient has previously been included in one of the two H. Lundbeck A/S post-marketing studies, 99823 or 99824
- The patient is, in the opinion of the investigator, unlikely to comply with the study protocol or unsuitable for any other reason
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
9809 Patients enrolled
Trial Details
Trial ID
NCT00856583
Start Date
July 1 2002
End Date
February 1 2008
Last Update
August 19 2011
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