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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 489 participants |
| Start Date | 2007-10 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
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.
Learn More About Clinical Trials
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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