At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 240 enrolled
Drug / intervention
Lurasidone HC1 +1 moredrug
Likely dose
Lurasidone HC1 160 mgfrom 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.
A Phase 3 Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Lurasidone in Subjects With Schizophrenia (PEARL 3 Extension Study)
In Brief
A Phase 3 clinical trial evaluating Lurasidone HC1 and Quetiapine XR for Chronic Schizophrenia. Completed, enrolled 240 participants across 65 sites in 6 countries.
Detailed Summary
Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Schizophrenia
CountriesColombia, India, Romania, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartDec 2008
Primary CompletionJul 2011
TodayJul 2026
First PostedNov 13, 2008
Enrollment StartDec 1, 2008
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.6 years ago
Interventions
Lurasidone HC1drug
Lurasidone 40-160 mg/day flexibly dosed.
Quetiapine XRdrug
Quetiapine XR 200-800 mg/day flexibly dosed.