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NCT01911442 · ClinicalTrials.gov registry record · Phase 3
Lurasidone Pediatric Autism Study
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
NCT01911442 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 150 participants.
The verdict
NCT01911442, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in the community setting.
Interventions
- DRUG Placebo
- DRUG Lurasidone
- DRUG Lurasidone 20 mg daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01911442
The ClinicalTrials.gov registry entry for NCT01911442 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01911442 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01911442 about?
NCT01911442 is a clinical study titled "Lurasidone Pediatric Autism Study". This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent subjects with irritability associated with autistic disorder who reside in ...
What is the current status of trial NCT01911442?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2013-08. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01911442?
The interventions under investigation include: Placebo (DRUG), Lurasidone (DRUG), Lurasidone 20 mg daily (DRUG).
Who is sponsoring clinical trial NCT01911442?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
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