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NCT03557931 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication
A Phase 2 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 233
- Enrollment target
NCT03557931 is a Phase 2 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 233 participants.
The verdict
NCT03557931, a Phase 2 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 233 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the efficacy of ASP4345 on cognitive impairment compared to placebo using change from baseline in MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score (excluding social cognition domain). The primary estimand used a Hypothetical Strategy and compared participants as though the participant had continued on the assigned treatment and to evaluate the safety and tolerability of ASP4345 compared to placebo. This study also evaluated the effects of ASP4345 compared to placebo on functional capacity using the University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) total score and evaluated the pharmacokinetic profile of ASP4345.
Interventions
- DRUG placebo
- DRUG risperidone
- DRUG olanzapine
- DRUG quetiapine
- DRUG ASP4345
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2018-07-13 |
| Est. Completion | 2019-10-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03557931
The ClinicalTrials.gov registry entry for NCT03557931 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 233 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT03557931 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03557931 about?
NCT03557931 is a clinical study titled "A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication". The purpose of this study was to evaluate the efficacy of ASP4345 on cognitive impairment compared to placebo using change from baseline in MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score (excluding social cognition domain). The primary estimand used a Hypothetical Strategy...
What is the current status of trial NCT03557931?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 233 participants. The study started on 2018-07-13. Estimated completion is 2019-10-21.
What interventions are being tested in trial NCT03557931?
The interventions under investigation include: placebo (DRUG), risperidone (DRUG), olanzapine (DRUG), quetiapine (DRUG), ASP4345 (DRUG).
Who is sponsoring clinical trial NCT03557931?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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