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Pediatric Open-Label Extension Study

NCT01914393 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 702

Last updated 2019-12-19

Study results available
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Summary

This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326

Conditions

Interventions

DRUG

Lurasidone 20, 40, 60, 80 mg, flexibly dosed

Lurasidone 20, 40, 60, 80 mg once daily, flexibly dosed

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2018-10-17
Completion
2018-10-17

Countries

  • United States
  • Bulgaria
  • Colombia
  • France
  • Hungary
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • South Korea
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

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 NCT01914393 on ClinicalTrials.gov