Study to Evaluate the Efficacy and Safety of Aripiprazole
NCT02069977 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 79
Last updated 2014-03-11
Summary
* To evaluate the efficacy of flexibly dosed aripiprazole in reducing serious behavioral problems in Asian children and adolescents with a diagnosis of autism spectrum disorder, as measured by change from baseline to endpoint on the irritability subscale of the aberrant behavior checklist (ABC-I).
* To evaluate the long-term safety and tolerability of flexibly dosed aripiprazole in the treatment of serious behavioral problems in Asian children and adolescents with a diagnosis of autism spectrum disorder.
Conditions
Interventions
- DRUG
-
Aripiprazole
Sponsors & Collaborators
-
Korea Otsuka International Asia Arab
collaborator INDUSTRY -
Yoo-Sook Joung
lead OTHER
Principal Investigators
-
Yoo-Sook Joung, MD. PhD. · Sumsung Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 6 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2016-02-29
- Completion
- 2016-02-29
Countries
- Philippines
- South Korea
- Thailand
Study Locations
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