Trials / Completed
CompletedNCT03345979
A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
A Phase 3b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia in Subjects Hospitalized for Acute Exacerbation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy of initiating treatment of schizophrenia with ARISTADA INITIO plus 30 mg oral aripiprazole followed by a 2-month dose of AL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | Aripiprazole Lauroxil | Intramuscular injection; study drug provided using a pre-filled syringe |
| DRUG | Paliperidone Palmitate | Intramuscular injection |
Timeline
- Start date
- 2017-11-15
- Primary completion
- 2019-03-12
- Completion
- 2019-03-12
- First posted
- 2017-11-17
- Last updated
- 2020-08-11
- Results posted
- 2020-08-11
Locations
16 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03345979. Inclusion in this directory is not an endorsement.