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NCT01566162 · ClinicalTrials.gov registry record · Phase 3

A Twelve Week, Open Label Extension Study in Patients With Schizophrenia

A Phase 3 study, sponsored by Sumitomo Pharma America.

Completed
Registry status
Phase 3
Development phase
191
Enrollment target

NCT01566162: Completed Phase 3 study, sponsored by Sumitomo Pharma America.

NCT01566162 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 191 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01566162, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.

COMPLETED
Registry status
Phase 3
Development phase
191 participants
Enrollment target

Study Summary

This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.

Primary Outcome

Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)

Interventions

  • DRUG Lurasidone

Trial Details

FieldValue
Enrollment Target 191 participants
Start Date 2012-04
Est. Completion 2013-11
Phase Phase 3
Sumitomo Pharma America

168 total trials

What the finished NCT01566162 record still lists

NCT01566162 is an interventional study that assigns participants to a tested intervention. The registered 191 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 1 intervention - of which Lurasidone is the first listed.

NCT01566162 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01566162 about?

NCT01566162 is a clinical study titled "A Twelve Week, Open Label Extension Study in Patients With Schizophrenia". This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.

What is the current status of trial NCT01566162?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 191 participants. The study started on 2012-04. Estimated completion is 2013-11.

What interventions are being tested in trial NCT01566162?

The interventions under investigation include: Lurasidone (DRUG).

Who is sponsoring clinical trial NCT01566162?

This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01566162's enrollment target sits among peer trials

191 1402nd of 2000 higher than 599 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01566162, the US trial registry maintained by the National Library of Medicine. NCT01566162 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.