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A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia

NCT01469039 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 623

Last updated 2019-01-30

Study results available
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Summary

The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.

Conditions

Interventions

DRUG

ALKS 9072

Intramuscular (IM) injection, 441 mg or 882 mg given monthly

DRUG

Placebo

Placebo for IM injection, given monthly

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • Alkermes Medical Director · Alkermes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-01-31
Completion
2014-03-31

Countries

  • United States
  • Bulgaria
  • Malaysia
  • Philippines
  • Romania
  • Russia
  • South Korea
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01469039 on ClinicalTrials.gov