At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 518 enrolled
Drug / intervention
BI 409306 100 mg QD +4 moredrug
Likely dose
BI 409306 100 mg QDfrom 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 Study to Evaluate the Efficacy, Safety, and Tolerability of Four Orally Administrated Doses of BI 409306 During a 12-week Treatment Period in Patients With Schizophrenia on Stable Antipsychotic Treatment
In Brief
A Phase 2 clinical trial evaluating BI 409306 100 mg QD, BI 498306 50 mg QD, and 3 other interventions for Schizophrenia. Completed, enrolled 518 participants across 43 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesCanada, Germany, Japan, Taiwan, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartNov 2014
Primary CompletionMay 2016
Study CompletionJun 2016
TodayJul 2026
First PostedNov 4, 2014
Enrollment StartNov 10, 2014
Primary CompletionMay 26, 2016
Study CompletionJun 13, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.7 years ago
Interventions
BI 409306 100 mg QDdrug
BI 498306 50 mg QDdrug
Placebodrug
BI 498306 25 mg QDdrug
BI 409306 10 mg QDdrug