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NCT03351244 · ClinicalTrials.gov registry record · Phase 2
This Study Tests Whether BI 409306 Prevents Patients With Schizophrenia From Becoming Worse. This Study Looks at How Well Patients Tolerate BI 409306 and How Effective it is Over 6 Months
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 2
- Development phase
- 264
- Enrollment target
NCT03351244: Clinical Trial Phase 2 study, sponsored by Boehringer Ingelheim.
NCT03351244 is a Phase 2 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 264 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03351244, a Phase 2 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 264 participants
- Enrollment target
Study Summary
The objective of the study is to investigate the efficacy, safety and tolerability of BI 409306 once daily compared with placebo given for 28 weeks in patients with schizophrenia on antipsychotic treatment. The study is designed to show superiority of BI 409306 over placebo in preventing relapse of schizophrenia symptoms.
Primary Outcome
The incidence rate of first relapse after 28 weeks of treatment is reported. For each treatment group, the incidence rate was calculated as the number of events / sum of the observational time (patient year) over all participants in this treatment group.
Interventions
- DRUG Placebo
- DRUG BI 409306
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2017-12-07 |
| Est. Completion | 2021-03-31 |
| Phase | Phase 2 |
Why NCT03351244 stopped before completion
NCT03351244 is an interventional study that assigns participants to a tested intervention. The registered 264 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 (98% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03351244 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03351244 about?
NCT03351244 is a clinical study titled "This Study Tests Whether BI 409306 Prevents Patients With Schizophrenia From Becoming Worse. This Study Looks at How Well Patients Tolerate BI 409306 and How Effective it is Over 6 Months". The objective of the study is to investigate the efficacy, safety and tolerability of BI 409306 once daily compared with placebo given for 28 weeks in patients with schizophrenia on antipsychotic treatment. The study is designed to show superiority of BI 409306 over placebo in preventing relapse of ...
What is the current status of trial NCT03351244?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 264 participants. The study started on 2017-12-07. Estimated completion is 2021-03-31.
What interventions are being tested in trial NCT03351244?
The interventions under investigation include: Placebo (DRUG), BI 409306 (DRUG).
Who is sponsoring clinical trial NCT03351244?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03351244's enrollment target sits among peer trials
264 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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