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

Study results available
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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

Placebo

DRUG

BI 498306 25 mg QD

DRUG

BI 409306 10 mg QD

Sponsors & Collaborators

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02281773 on ClinicalTrials.gov