CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 266 enrolled
Drug / intervention
ALKS 3831drug
Likely dose
ALKS 3831 (olanzapine 10 mg, 15 mg, or 20 mg with samidorphan 10 mg, coated bilayer tablet)AI-extracted
Key inclusion· 1
  • ✓Completed 24-week treatment period in antecedent study ALK3831-A303 within 7 days
Key exclusion· 3
  • ✕Currently taking medications contraindicated with olanzapine or with significant drug-interaction potential with olanzapine
  • ✕Positive test for drugs of abuse at study entry
  • ✕Pregnant, planning to become pregnant, or breastfeeding

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02873208
NCT02873208Phase 3Completed
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A Phase 3, Multicenter Study to Assess the Long Term Safety and Tolerability of ALKS 3831 in Subjects With Schizophrenia

Alkermes, Inc.·interventional·Posted Aug 19, 2016·Updated Jul 21, 2021

In Brief

A Phase 3 clinical trial evaluating ALKS 3831 for Schizophrenia. Completed, enrolled 266 participants across 45 sites in 2 countries.

Detailed Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 19, 2016
Enrollment StartAug 7, 2016
Primary CompletionOct 17, 2019
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 9.9 years ago

Interventions

ALKS 3831drug

Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan