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NCT00868959 · ClinicalTrials.gov registry record · Phase 3
Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 817
- Enrollment target
NCT00868959: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT00868959 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 817 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00868959, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 817 participants
- Enrollment target
Study Summary
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression
Primary Outcome
Rate of treatment-emergent adverse events in subjects who have completed (ie, reached 6-week endpoint) of Study D1050235 (NCT00868452), Study D1050236 (NCT00868699) or Study D1050292 (NCT01284517)
Interventions
- DRUG lurasidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 817 participants |
| Start Date | 2009-04 |
| Est. Completion | 2013-02 |
| Phase | Phase 3 |
What the finished NCT00868959 record still lists
NCT00868959 is an interventional study that assigns participants to a tested intervention. The registered 817 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which lurasidone is the first listed.
NCT00868959 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00868959 about?
NCT00868959 is a clinical study titled "Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression". This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression
What is the current status of trial NCT00868959?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 817 participants. The study started on 2009-04. Estimated completion is 2013-02.
What interventions are being tested in trial NCT00868959?
The interventions under investigation include: lurasidone (DRUG).
Who is sponsoring clinical trial NCT00868959?
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 NCT00868959's enrollment target sits among peer trials
817 406th of 2000 higher than 1,595 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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