CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 478 enrolled
Drug / intervention
Lurasidone +3 moredrug
Likely dose
Lurasidone 40 mg tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00615433
NCT00615433Phase 3Completed

A Phase 3 Randomized, Placebo-and Active Comparator Controlled, Clinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia.

Sumitomo Pharma America, Inc.·interventional·Posted Feb 14, 2008·Updated Jun 12, 2015

In Brief

A Phase 3 clinical trial evaluating Lurasidone, Olanzapine, and 2 other interventions for Schizophrenia. Completed, enrolled 478 participants across 52 sites in 5 countries.

Detailed Summary

Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesColombia, India, Lithuania, Philippines, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 14, 2008
Enrollment StartJan 1, 2008
Primary CompletionDec 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 18.4 years ago

Interventions

Lurasidonedrug

120mg/day

Olanzapinedrug

15mg/day

Placebo comparatordrug

Placebor Comparator

Lurasidone 40 mg tabletsdrug

Lurasidone 40 mg tablets