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NCT00845026 · ClinicalTrials.gov registry record · Phase 2
A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients
A Phase 2 study, sponsored by Denovo Biopharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 261
- Enrollment target
NCT00845026: Completed Phase 2 study, sponsored by Denovo Biopharma.
NCT00845026 is a Phase 2 study that has completed, run by Denovo Biopharma. The registered enrollment target is 261 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00845026, a Phase 2 study, has completed, sponsored by Denovo Biopharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 261 participants
- Enrollment target
Study Summary
The primary objective of this study was to assess time to discontinuation due to lack of tolerability among patients with schizophrenia receiving LY2140023, given orally twice daily for 24 weeks, versus those on atypical antipsychotic standard-of-care (SOC) treatment. Lack of tolerability was defined as discontinuation due to adverse events (AEs). Patients who completed the active treatment phase were eligible to continue to an optional 28 weeks of treatment extension phase. This extension phase assessed key safety and efficacy measures.
Interventions
- DRUG risperidone
- DRUG olanzapine
- DRUG aripiprazole
- DRUG LY2140023
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
What the finished NCT00845026 record still lists
NCT00845026 is an interventional study that assigns participants to a tested intervention. The registered 261 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% higher).
The record links to 0 conditions, and to 4 interventions - of which risperidone is the first listed.
NCT00845026 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00845026 about?
NCT00845026 is a clinical study titled "A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients". The primary objective of this study was to assess time to discontinuation due to lack of tolerability among patients with schizophrenia receiving LY2140023, given orally twice daily for 24 weeks, versus those on atypical antipsychotic standard-of-care (SOC) treatment. Lack of tolerability was define...
What is the current status of trial NCT00845026?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 261 participants. The study started on 2009-03. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00845026?
The interventions under investigation include: risperidone (DRUG), olanzapine (DRUG), aripiprazole (DRUG), LY2140023 (DRUG).
Who is sponsoring clinical trial NCT00845026?
This trial is sponsored by Denovo Biopharma, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00845026's enrollment target sits among peer trials
261 210th of 2000 higher than 1,791 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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