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NCT01457339 · ClinicalTrials.gov registry record · Phase 1
Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia
A Phase 1 study of Schizophrenia, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 2
- Study locations
NCT01457339 is a Phase 1 study of Schizophrenia that has completed, run by Shire. The registered enrollment target is 31 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT01457339, a Phase 1 study of Schizophrenia, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a multiple ascending dose study; the purpose of this study is to examine the safety, tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic Patients who are currently maintained on a stable dose of an antipsychotic medication.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SPD489 (Lisdexamfetamine dimesylate)
Study Locations (2)
California
- California Clinical Trials - Glendale
- Collaborative Neuroscience Network, Inc - Long Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-10-21 |
| Est. Completion | 2012-01-20 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01457339
The ClinicalTrials.gov registry entry for NCT01457339 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (86% lower). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01457339 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT01457339 about?
NCT01457339 is a clinical study titled "Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia". This is a multiple ascending dose study; the purpose of this study is to examine the safety, tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic Patients who are currently maintained on a stable dose of an antipsychotic medication.
What is the current status of trial NCT01457339?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2011-10-21. Estimated completion is 2012-01-20.
What conditions does trial NCT01457339 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT01457339?
The interventions under investigation include: Placebo (DRUG), SPD489 (Lisdexamfetamine dimesylate) (DRUG).
Who is sponsoring clinical trial NCT01457339?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01457339 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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