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NCT01895452 · ClinicalTrials.gov registry record · Phase 3
An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
A Phase 3 study of Schizophrenia, sponsored by Alkermes.
- Completed
- Registry status
- Phase 3
- Development phase
- 291
- Enrollment target
- 20
- Study locations
NCT01895452: Completed Phase 3 study of Schizophrenia, sponsored by Alkermes.
NCT01895452 is a Phase 3 study of Schizophrenia that has completed, run by Alkermes. The registered enrollment target is 291 participants, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (33% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01895452, a Phase 3 study of Schizophrenia, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 291 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.
Primary Outcome
This measure includes all incidences, including those that occurred \>5%.
Conditions Studied
Interventions
- DRUG ALKS 9072, Low Dose
- DRUG ALKS 9072, High Dose
Study Locations (20)
California
- Alkermes Investigational Site - Garden Grove
- Alkermes Investigational Site - Oakland
- Alkermes Investigational Site - Oceanside
- Alkermes Investigational Site - Orange
Illinois
- Alkermes Investigational Site - Chicago
- Alkermes Investigational Site - Chicago
- Alkermes Investigational Site - Hoffman Estates
Other
- Alkermes Investigational Site - Burgas
- Alkermes Investigational Site - Novi Iskar
- Alkermes Investigational Site - Pazardzhik
Arkansas
- Alkermes Investigational Site - Little Rock
- Alkermes Investigational Site - Little Rock
Florida
- Alkermes Investigational Site - Fort Lauderdale
- Alkermes Investigational Site - Leesburg
Texas
- Alkermes Investigational Site - Dallas
- Alkermes Investigational Site - Dallas
District of Columbia
- Alkermes Investigational Site - Washington D.C.
Georgia
- Alkermes Investigational Site - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-06 |
| Phase | Phase 3 |
What the finished NCT01895452 record still lists
NCT01895452 is an interventional study that assigns participants to a tested intervention. The registered 291 participants enrollment target is mid-sized for trials with a published cap, above the 218-participant average among 315 other Schizophrenia trials with a reported enrollment target (33% higher).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which ALKS 9072, Low Dose is the first listed.
NCT01895452 names 20 study sites across 10 states, led by California, Illinois, Other.
Frequently Asked Questions
What is clinical trial NCT01895452 about?
NCT01895452 is a clinical study titled "An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)". This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.
What is the current status of trial NCT01895452?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 291 participants. The study started on 2013-07. Estimated completion is 2016-06.
What conditions does trial NCT01895452 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT01895452?
The interventions under investigation include: ALKS 9072, Low Dose (DRUG), ALKS 9072, High Dose (DRUG).
Who is sponsoring clinical trial NCT01895452?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01895452 being conducted?
This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01895452's enrollment target sits among peer trials
291 64th of 315 higher than 252 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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