Lurasidone Extended Use Study

NCT01485640 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2016-11-04

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Lurasidone

Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director, MD · Sumitomo Pharma America, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

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

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01485640 on ClinicalTrials.gov