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.
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|ClinicalTrials.gov Identifier: NCT00645307|
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Extended Release OROS® Paliperidone||Phase 3|
The primary objective of the open-label extension was the long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia. In addition, the long-term efficacy and effect of ER OROS paliperidone on overall functioning and personal and social functioning, as well as quality of life, health economics, and subjective sleep measures, was explored. This open-label extension study followed a recurrence prevention study (R076477-SCH-301) that had both an open-label run-in/stabilization phase and a double-blind, placebo-controlled phase.
Open-label study drug (ER OROS paliperidone 3 mg to 15 mg/day) was administered for 52 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||235 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2004|
|Study Completion Date :||August 2006|
- Long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645307
|Study Director:||Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|