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Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia

NCT01662648 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1117

Last updated 2014-05-05

Study results available
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Summary

The purpose of this study is to explore the efficacy of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were previously unsuccessfully treated with other oral antipsychotics.

Conditions

Interventions

DRUG

Paliperidone ER

Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion.

Sponsors & Collaborators

  • Janssen Pharmaceutica

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutica Clinical Trial · Janssen Pharmaceutica

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-04-30
Completion
2009-04-30

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Entities

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 NCT01662648 on ClinicalTrials.gov