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NCT00789698 · ClinicalTrials.gov registry record · Phase 3
Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic Schizophrenia
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
NCT00789698: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT00789698 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 240 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00789698, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 240 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 effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia.
Primary Outcome
Time to relapse will be defined as the earliest occurrence of any of the following: * Worsening of \>= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale \>=3 * rehospitalization for worsening of psychosis * emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox propo
Interventions
- DRUG Quetiapine XR
- DRUG Lurasidone HC1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2008-12 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
What the finished NCT00789698 record still lists
NCT00789698 is an interventional study that assigns participants to a tested intervention. The registered 240 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 (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Quetiapine XR is the first listed.
NCT00789698 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00789698 about?
NCT00789698 is a clinical study titled "Lurasidone HCl - A Long Term Phase 3 Study of Patients With Chronic 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 effective, tolerable, and safe as compared with quetiapine XR long term among schizophrenic outpatients with chronic schizophrenia.
What is the current status of trial NCT00789698?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2008-12. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00789698?
The interventions under investigation include: Quetiapine XR (DRUG), Lurasidone HC1 (DRUG).
Who is sponsoring clinical trial NCT00789698?
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 NCT00789698's enrollment target sits among peer trials
240 1273rd of 2000 higher than 710 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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