Trials / Completed
CompletedNCT01469039
A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects With Acute Exacerbation of Schizophrenia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 623 (actual)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALKS 9072 | Intramuscular (IM) injection, 441 mg or 882 mg given monthly |
| DRUG | Placebo | Placebo for IM injection, given monthly |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2014-01-01
- Completion
- 2014-03-01
- First posted
- 2011-11-10
- Last updated
- 2019-01-30
- Results posted
- 2016-01-22
Locations
84 sites across 8 countries: United States, Bulgaria, Malaysia, Philippines, Romania, Russia, South Korea, Ukraine
Source: ClinicalTrials.gov record NCT01469039. Inclusion in this directory is not an endorsement.