CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 121 enrolled
Drug / intervention
Treatment as usual (TAU), Paliperidone ERdrug
Likely dose
Treatment as usual (TAU), Paliperidone ER 6mgfrom 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/NCT00535145
NCT00535145Phase 4Completed
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A Single-arm Evaluation of the Safety of Paliperidone Extended-Release (ER) in Subjects With Schizophrenia or Schizoaffective Disorder With Hepatic Disease

Ortho-McNeil Janssen Scientific Affairs, LLC·interventional·Posted Sep 26, 2007·Updated Jul 25, 2014

In Brief

A Phase 4 clinical trial evaluating Treatment as usual (TAU), Paliperidone ER for Schizophrenia and 2 related conditions. Completed, enrolled 121 participants across 21 sites.

Detailed Summary

The purpose of this study is to evaluate the tolerability and safety of paliperidone ER (extended-release) in doses between 3 milligrams per day and 12 milligrams per day in the treatment of patients with schizophrenia or schizoaffective disorder and liver disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizoaffective Disorder, Psychotic Disorders
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 26, 2007
Enrollment StartOct 1, 2007
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.8 years ago

Interventions

Treatment as usual (TAU), Paliperidone ERdrug

Treatment as usual is the subject's current antipsychotic and doses for 4 weeks; TAU AND Paliperidone ER - per site investigator for 1 week; Paliperidone ER 6mg once daily for 1 week; Paliperidone ER-3 to 12mg tablets once daily for 4 weeks