Efficacy and Safety of a Long Acting Anti-Psychotic Versus Placebo in Patients With Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00101634|
Recruitment Status : Completed
First Posted : January 13, 2005
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Paliperidone palmitate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||518 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq, 50 mg eq, and 100 mg eq) of Paliperidone Palmitate in Patients With Schizophrenia|
|Study Start Date :||December 2004|
|Actual Study Completion Date :||March 2006|
- Change in total PANSS score from baseline to the end of the double blind treatment period.
- PSP and CGI-S scores from baseline to the end of of the double-blind treatment. Incidence of adverse events, labs and ECGs 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): NCT00101634
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|