Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use

PHASE3CompletedINTERVENTIONAL
Enrollment

9,809

Participants

Timeline

Start Date

July 31, 2002

Primary Completion Date

February 29, 2008

Study Completion Date

February 29, 2008

Conditions
Schizophrenia
Interventions
DRUG

Sertindole

Sertindole was supplied as 4, 12, 16, and 20 mg tablets. The start and maintenance dosages as well as dose titration were set by the investigator, in accordance with the national Summary of Product Characteristics (SPC) for sertindole; in countries where sertindole was not marketed, the European Union (EU) SPC applied (all national and EU SPCs were essentially identical). Recommended dose range: 12 to 20 mg/day. The investigators were instructed to contact H. Lundbeck A/S if they deemed it necessary to increase the dose of sertindole to 24 mg/day, which was allowed in exceptional cases

DRUG

Risperidone

Risperidone was supplied as 1, 2, 3, and 4 mg tablets. The start and maintenance dosages as well as dose titration were set by the investigator, in accordance with the national SPC for risperidone. Recommended dose range: 2 to 8 mg/day

All Listed Sponsors
lead

H. Lundbeck A/S

INDUSTRY

NCT00856583 - Safety Study of Sertindole Versus Risperidone Under Normal Conditions of Use | Biotech Hunter | Biotech Hunter