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NCT00194064 · ClinicalTrials.gov registry record · Phase 3
Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine
A Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 18
- Enrollment target
NCT00194064 is a Phase 3 study that was terminated before completion, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 18 participants.
The verdict
NCT00194064, a Phase 3 study, was terminated before completion, sponsored by University Hospitals Cleveland Medical Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 18 participants
- Enrollment target
Study Summary
Inpatient Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Mania: This study recruits adult subjects who are diagnosed with Bipolar I Disorder and presently experiencing an episode of mania. Patients must be willing to spend initial 7 days in the hospital to observe response to medication. Patients must be refractory (intolerant or non-responsive) to treatment with lithium and valproate or carbamazepine. Patients receive study-related care at no cost. This study is sponsored by Eli Lilly and Company.
Interventions
- DRUG Olanzapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2002-07 |
| Est. Completion | 2006-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00194064
The ClinicalTrials.gov registry entry for NCT00194064 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Olanzapine is the first listed.
NCT00194064 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00194064 about?
NCT00194064 is a clinical study titled "Pilot Study Evaluating the Safety and Efficacy of Open-Label Olanzapine". Inpatient Study Evaluating the Safety and Efficacy of Open-Label Olanzapine Monotherapy in Treatment Refractory Bipolar Mania: This study recruits adult subjects who are diagnosed with Bipolar I Disorder and presently experiencing an episode of mania. Patients must be willing to spend initial 7 days...
What is the current status of trial NCT00194064?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 18 participants. The study started on 2002-07. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00194064?
The interventions under investigation include: Olanzapine (DRUG).
Who is sponsoring clinical trial NCT00194064?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
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