A Study of Effectiveness and Safety of Paliperidone Extended-release (ER) Tablets in the Prevention of Recurrence in Adult Patients With Schizophrenia.
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|ClinicalTrials.gov Identifier: NCT00086320|
Recruitment Status : Completed
First Posted : July 1, 2004
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Paliperidone ER||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||111 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Evaluating Paliperidone Extended Release Tablets in the Prevention of Recurrence in Subjects With Schizophrenia|
|Study Start Date :||March 2004|
|Actual Study Completion Date :||August 2005|
- Time to recurrence, defined as the time between randomization to treatment in the double-blind period and the first documentation of a recurrence.
- Change in PANSS total and subscale scores from randomization to each visit and to the end of the study. Change from baseline in CGI-S at each assessment time point and at endpoint. Incidence of adverse events throughout study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086320
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|