CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 98 enrolled
Drug / intervention
Lurasidone 20 mg +2 moredrug
Likely dose
Lurasidone 20 mg, 40 mg, or 80 mg orally once dailyAI-extracted
Key inclusion· 1
  • ✓Successful completion of participation in prior protocol D1050049
Key exclusion· 3
  • ✕Substance abuse
  • ✕Prolactin level ≥200 ng/mL at baseline
  • ✕Pregnancy

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

Search/NCT00044005
NCT00044005Phase 2Completed
CompareCT.gov

A Randomized, Open-Label, Dose-Blinded, Multicenter, 6-Month Study of Safety and Tolerability of 3 Dose Levels of SM-13496 (Lurasidone) in Patients With Schizophrenia

Sumitomo Pharma America, Inc.·interventional·Posted Aug 20, 2002·Updated Apr 17, 2014

In Brief

A Phase 2 clinical trial evaluating Lurasidone 20 mg, Lurasidone 40 mg, and 1 other intervention for Schizophrenia. Completed, enrolled 98 participants across 26 sites.

Detailed Summary

The purpose of this study is to evaluate the long-term safety of SM-13496 in patients with schizophrenia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 20, 2002
Enrollment StartSep 1, 2002
Primary CompletionNov 1, 2003
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 23.9 years ago

Interventions

Lurasidone 20 mgdrug

Lurasidone 20mg oral tablet taken once daily for 6-months

Lurasidone 40 mgdrug

Lurasidone 40mg oral tablets taken once daily

Lurasidone 80mgdrug

Lurasidone 80mg oral tablet taken once daily