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NCT00615433 · 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
- 478
- Enrollment target
NCT00615433: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT00615433 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 478 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00615433, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 478 participants
- Enrollment target
Study Summary
Lurasidone HCl is a compound 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 rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.
Interventions
- DRUG Olanzapine
- DRUG Placebo comparator
- DRUG Lurasidone
- DRUG Lurasidone 40 mg tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-01 |
| Phase | Phase 3 |
What the finished NCT00615433 record still lists
NCT00615433 is an interventional study that assigns participants to a tested intervention. The registered 478 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 (38% lower).
The record links to 0 conditions, and to 4 interventions - of which Olanzapine is the first listed.
NCT00615433 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00615433 about?
NCT00615433 is a clinical study titled "Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia". Lurasidone HCl is a compound 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 NCT00615433?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 478 participants. The study started on 2008-01. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00615433?
The interventions under investigation include: Olanzapine (DRUG), Placebo comparator (DRUG), Lurasidone (DRUG), Lurasidone 40 mg tablets (DRUG).
Who is sponsoring clinical trial NCT00615433?
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 NCT00615433's enrollment target sits among peer trials
478 805th of 2000 higher than 1,194 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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