Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02281773 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Efficacy, Safety and Tolerability of Four Different Doses of BI 409306 Compared to Placebo Given for 12 Weeks in Patients With Schizophrenia on Stable Antipsychotic Treatment.
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 518
- Enrollment target
NCT02281773: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT02281773 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 518 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (289% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02281773, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 518 participants
- Enrollment target
Study Summary
The objective of the study is to investigate the efficacy, safety and tolerability of four different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.
Primary Outcome
MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning problem solving, and social cognition. The composite score was calculated by summing over the standardised score of each domain for analysis and it varies from -20 to 99 with higher score indicating better outcome. The trial was set up as "learn and confirm" model including 2 stages. Stage 1 analysis was conducted to identify t
Interventions
- DRUG Placebo
- DRUG BI 409306 100 mg QD
- DRUG BI 498306 50 mg QD
- DRUG BI 498306 25 mg QD
- DRUG BI 409306 10 mg QD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 518 participants |
| Start Date | 2014-11-10 |
| Est. Completion | 2016-06-13 |
| Phase | Phase 2 |
What the finished NCT02281773 record still lists
NCT02281773 is an interventional study that assigns participants to a tested intervention. The registered 518 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 (289% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02281773 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02281773 about?
NCT02281773 is a clinical study titled "A Study to Investigate the Efficacy, Safety and Tolerability of Four Different Doses of BI 409306 Compared to Placebo Given for 12 Weeks in Patients With Schizophrenia on Stable Antipsychotic Treatment.". The objective of the study is to investigate the efficacy, safety and tolerability of four different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.
What is the current status of trial NCT02281773?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 518 participants. The study started on 2014-11-10. Estimated completion is 2016-06-13.
What interventions are being tested in trial NCT02281773?
The interventions under investigation include: Placebo (DRUG), BI 409306 100 mg QD (DRUG), BI 498306 50 mg QD (DRUG), BI 498306 25 mg QD (DRUG), BI 409306 10 mg QD (DRUG).
Who is sponsoring clinical trial NCT02281773?
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 NCT02281773's enrollment target sits among peer trials
518 67th of 2000 higher than 1,934 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04524871 · 518 participants · Phase 1
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)
- NCT07112196 · 518 participants · Phase 2
Visugromab in Cachexia International Trial
- NCT05676450 · 517 participants · NA
Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas
- NCT02323581 · 520 participants · NA
Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI