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.
NCT02281773 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 518
Last updated 2017-10-19
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.
Conditions
Interventions
- DRUG
-
BI 409306 100 mg QD
- DRUG
-
BI 498306 50 mg QD
- DRUG
- DRUG
-
BI 498306 25 mg QD
- DRUG
-
BI 409306 10 mg QD
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-10
- Primary Completion
- 2016-05-26
- Completion
- 2016-06-13
Countries
- United States
- Canada
- Germany
- Japan
- Taiwan
Study Locations
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