24-Week Open Label Extension to a Randomized, 6-Week Double Blind, Placebo Controlled Study, to Evaluate the Safety and Tolerability of Flexible Doses of Extended Release OROS® Paliperidone in the Treatment of Geriatric Subjects With Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00752427|
Recruitment Status : Completed
First Posted : September 15, 2008
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Paliperidone ER OROS®||Phase 3|
The primary objective of the open-label extension phase was the long-term assessment of safety and tolerability of Extended Release (ER) OROS paliperidone (3 mg to 12 mg/day) in subjects (>65 years of age) with schizophrenia, and the secondary objective was the assessment of long-term efficacy.
Paliperidone ER OROS® tablet formulation (3 to 12 mg/day) to be taken orally
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||R076477-SCH-702: a 24 Week Open-Label Extension to R076477-SCH-302|
|Study Start Date :||June 2004|
|Actual Study Completion Date :||November 2005|
- Long-term assessment of safety and tolerability of Extended Release (ER) OROS paliperidone (3 mg to 12 mg/day) in subjects (>65 years of age) with schizophrenia
- Assessment of long-term efficacy of Extended Release (ER) OROS paliperidone (3 mg to 12 mg/day) in subjects (>65 years of age) with schizophrenia, .
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): NCT00752427
|Study Director:||Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|