Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT00650793
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2008-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 52-week, Open-label Extension Study Following a 6-week, Double-blind, Placebo- and Active- Controlled Study (R076477-SCH-303) to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia
Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Organization:
Study Overview
Official Title:
A Randomized, DB, PC and AC, Parallel Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Extended Release OROS� Paliperidone (6, 9, 12 mg/Day) and Olanzapine (10 mg/Day), With Open-Label Extension, in the Treatment of Subjects With Schizophrenia - Open Label Phase
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study was an Open Label Extension to a completed study that evaluated the efficacy and safety of 3 fixed dosages of Extended Release OROS® Paliperidone
Detailed Description:
This 52-week, open-label extension study followed a 6-week, double-blind, placebo- and active-controlled study (R076477-SCH-303) and was conducted at 52 sites in 11 countries. The primary objective of the open-label extension was the long-term assessment of safety and tolerability of flexibly-dosed ER OROS® paliperidone. The secondary objective was the assessment of long-term efficacy expressed as a function of change in the total Positive and Negative Syndrome Scale (PANSS) score, effect on positive and negative symptoms of schizophrenia by means of change in PANSS factor scores, and personal and social functioning, overall functioning, and quality of life parameters as measured by Personal and Social Performance Scale (PSP), Clinical Global Impression Scale - Severity (CGI-S), and Schizophrenia Quality of Life Scale (SQLS), respectively. Subjects in the open-label phase received flexibly dosed ER OROS® paliperidone (3 mg to 12 mg/day) for 52 weeks
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: