A 52 Week Open Label Extension Trial Following the Recurrence Prevention Study R076477-SCH-301 to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With an Open-Label Extension Evaluating Extended Release OROS® Paliperidone in the Prevention of Recurrence in Subjects With Schizophrenia - Open Label Phase
1 other identifier
interventional
235
0 countries
N/A
Brief Summary
The purpose of the study was an Open Label Extension to the recurrence prevention study to evaluate long-term safety and tolerability of paliperidone ER in subjects with schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 schizophrenia
Started May 2004
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 24, 2008
CompletedFirst Posted
Study publicly available on registry
March 27, 2008
CompletedJune 8, 2011
April 1, 2010
March 24, 2008
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia
Secondary Outcomes (1)
Long-term efficacy and effect of ER OROS paliperidone on overall functioning and personal and social functioning, quality of life, health economics, and subjective sleep measures
Interventions
Eligibility Criteria
You may qualify if:
- Subjects who had experienced a recurrence event during the double blind phase of Study R076477-SCH-301
- Remained recurrence free until the end of the double-blind phase, or were in the run-in or stabilization phases when the study was terminated
- Who signed the informed consent for the open-label extension
- And who the investigator agreed that open-label treatment was in the best interest of the subject were eligible to participate in the open-label extension
You may not qualify if:
- Not eligible to enter the open-label phase if believed to be at significant risk for suicidal or violent behavior during the open-label extension trial
- Were pregnant or had received an injection of a depot antipsychotic since entry into the preceding double-blind phase
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 24, 2008
First Posted
March 27, 2008
Study Start
May 1, 2004
Study Completion
August 1, 2006
Last Updated
June 8, 2011
Record last verified: 2010-04