Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use (SCoP)

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Lundbeck

Status and phase

Completed
Phase 3

Conditions

Schizophrenia

Treatments

Drug: Sertindole
Drug: Risperidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00856583
2004-000213-19 (EudraCT Number)
99824

Details and patient eligibility

About

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) when used under normal marketed conditions in the treatment of schizophrenia.

Full 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 with sertindole would not be offset by higher mortality rates when sertindole was used under more normal conditions of use. It was recognised that, in a clinical trial setting, strict patient selection and monitoring could lead to higher compliance in patient management and thereby to a lower mortality rate. Study 99824 was therefore designed in collaboration with the CHMP as an open-label, randomised study with minimum study management that focused on mortality and general patient safety. The duration of the treatment period was not fixed. No efficacy measures were included.

Enrollment

9,809 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

9,809 participants in 2 patient groups

Sertindole
Experimental group
Description:
Normally in the range of 4 to 20 mg/day
Treatment:
Drug: Sertindole
Risperidone
Active Comparator group
Description:
Normally in the range of 2 to 8 mg/day
Treatment:
Drug: Risperidone

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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