Trial Profile
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
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 08 Sep 2016
Price :
$35
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At a glance
- Drugs Paliperidone (Primary)
- Indications Schizophrenia
- Focus Registrational; Therapeutic Use
- Sponsors Janssen Research & Development
- 18 Jul 2016 Result of post-hoc analysis of this and one other phase III trial published in the International Clinical Psychopharmacology (2016).
- 14 Sep 2010 US FDA approved NDA for paliperidone for the acute and maintenance treatment of schizophrenia based data from this and other pivotal trials.
- 12 Dec 2007 The open-label extension phase of this trial has been completed, according to the media release of Janssen L.P. The open-label trial included 235 patients.