NCT00752427

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

R076477-SCH-702: a 24 Week Open-Label Extension to R076477-SCH-302

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this open-label study was to evaluate the safety and tolerability of flexible doses of Extended Release OROS® Paliperidone in the treatment of geriatric subjects with schizophrenia after completion of the initial double blind study

Detailed description

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

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Paliperidone ER OROS®

Timeline

• Start date: 2004-06-01
• Completion: 2005-11-01
• First posted: 2008-09-15
• Last updated: 2011-06-08