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NCT00549718 · ClinicalTrials.gov registry record · Phase 3

Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia

A Phase 3 study, sponsored by Sumitomo Pharma America.

Completed
Registry status
Phase 3
Development phase
489
Enrollment target

NCT00549718: Completed Phase 3 study, sponsored by Sumitomo Pharma America.

NCT00549718 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 489 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00549718, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.

COMPLETED
Registry status
Phase 3
Development phase
489 participants
Enrollment target

Study 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 more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

Primary Outcome

The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.

Interventions

  • DRUG Lurasidone HCl

Trial Details

FieldValue
Enrollment Target 489 participants
Start Date 2007-10
Est. Completion 2010-10
Phase Phase 3
Sumitomo Pharma America

168 total trials

What the finished NCT00549718 record still lists

NCT00549718 is an interventional study that assigns participants to a tested intervention. The registered 489 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 (37% lower).

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

NCT00549718 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00549718 about?

NCT00549718 is a clinical study titled "Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia". Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

What is the current status of trial NCT00549718?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 489 participants. The study started on 2007-10. Estimated completion is 2010-10.

What interventions are being tested in trial NCT00549718?

The interventions under investigation include: Lurasidone HCl (DRUG).

Who is sponsoring clinical trial NCT00549718?

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 NCT00549718's enrollment target sits among peer trials

489 783rd of 2000 higher than 1,217 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 NCT00549718, the US trial registry maintained by the National Library of Medicine. NCT00549718 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.