Who is sponsoring NCT01485640?

NCT01485640 is sponsored by Sumitomo Pharma America, Inc..

What condition does NCT01485640 study?

NCT01485640 studies Schizophrenia, Bipolar Disorder.

What is the status of NCT01485640?

NCT01485640 is currently COMPLETED.

Last reviewed 2016-09-29 · How we verify

A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study

NCT01485640 Phase 3 COMPLETED Results posted

This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.

Details

Lead sponsor	Sumitomo Pharma America, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	162
Start date	2011-06
Completion	2014-02

Conditions

Schizophrenia
Bipolar Disorder

Interventions

Lurasidone

Primary outcomes

Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs — 18 months
Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.

Countries

Canada, Colombia, Czechia, France, India, Lithuania, Romania, Russia, Serbia, Slovakia, South Africa, Ukraine