Trials / Completed
CompletedNCT02873208
A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
A Phase 3, Multicenter Study to Assess the Long Term Safety and Tolerability of ALKS 3831 in Subjects With Schizophrenia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 266 (actual)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALKS 3831 | Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan |
Timeline
- Start date
- 2016-08-07
- Primary completion
- 2019-10-17
- Completion
- 2019-10-17
- First posted
- 2016-08-19
- Last updated
- 2021-07-21
- Results posted
- 2021-07-21
Locations
45 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT02873208. Inclusion in this directory is not an endorsement.