At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 509 enrolled
Drug / intervention
BI 425809 dose 1 +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Randomised, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of 4 Oral Doses of BI 425809 Once Daily Over 12 Week Treatment Period in Patients With Schizophrenia
In Brief
A Phase 2 clinical trial evaluating BI 425809 dose 1, BI 425809 dose 2, and 3 other interventions for Schizophrenia. Completed, enrolled 509 participants across 81 sites in 11 countries.
Detailed Summary
The objective of the study is to investigate the efficacy, safety and pharmacokinetics of four different doses of BI 425809 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesAustria, Canada, Germany, Italy, Japan, Poland, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartJul 2016
Primary CompletionDec 2019
Study CompletionJan 2020
TodayJul 2026
First PostedJul 13, 2016
Enrollment StartJul 25, 2016
Primary CompletionDec 27, 2019
Study CompletionJan 29, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.0 years ago
Interventions
BI 425809 dose 1drug
BI 425809 dose 2drug
BI 425809 dose 3drug
BI 425809 dose 4drug
Placebodrug