CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 88 enrolled
Drug / intervention
Aripiprazole once-monthlydrug
Likely dose
Aripiprazole once-monthly 300 mgfrom 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.

Search/NCT01959035
NCT01959035Phase 3Completed
CompareCT.gov

Interventional, Open-label, Flexible-dose Extension Study of Aripiprazole Once-monthly in Patients With Schizophrenia

H. Lundbeck A/S·interventional·Posted Oct 9, 2013·Updated Mar 17, 2017

In Brief

A Phase 3 clinical trial evaluating Aripiprazole once-monthly for Schizophrenia. Completed, enrolled 88 participants across 1 site.

Detailed Summary

To obtain information on the safety, tolerability and effectiveness of aripiprazole once-monthly in a manner consistent with its intended use in everyday clinical practice in patients with schizophrenia who completed Study 14724A / NCT01795547.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
CollaboratorsOtsuka Pharmaceutical Co., Ltd.

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 9, 2013
Enrollment StartOct 1, 2013
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.7 years ago

Interventions

Aripiprazole once-monthlydrug

400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline