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NCT01710709 · ClinicalTrials.gov registry record · Phase 3
Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 748
- Enrollment target
NCT01710709 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 748 participants.
The verdict
NCT01710709, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 748 participants
- Enrollment target
Study Summary
This will be an open-label uncontrolled trial to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar I disorder. The trial will enroll subjects who completed Trial 31-08-250 and de novo subjects not participating in Trial 31-08-250.
Interventions
- DRUG Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 748 participants |
| Start Date | 2012-11 |
| Est. Completion | 2016-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01710709
The ClinicalTrials.gov registry entry for NCT01710709 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 748 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aripiprazole is the first listed.
NCT01710709 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01710709 about?
NCT01710709 is a clinical study titled "Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder". This will be an open-label uncontrolled trial to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar I disorder. The trial will enroll subjects who completed Trial 31-08-250 and de novo subjects not participating in Tri...
What is the current status of trial NCT01710709?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 748 participants. The study started on 2012-11. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01710709?
The interventions under investigation include: Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT01710709?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
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