At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 200 enrolled
Drug / intervention
Aripiprazole Lauroxil +1 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Aripiprazole Lauroxil and Paliperidone Palmitate for Schizophrenia. Completed, enrolled 200 participants across 16 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartNov 2017
First PostedNov 2017
Primary CompletionMar 2019
TodayJul 2026
First PostedNov 17, 2017
Enrollment StartNov 15, 2017
Primary CompletionMar 12, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.6 years ago
Interventions
Aripiprazole Lauroxilcombination
Intramuscular injection; study drug provided using a pre-filled syringe
Paliperidone Palmitatedrug
Intramuscular injection