Ignite Creation Date:
2024-05-05 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 9:47 AM
Study NCT ID:
NCT00650793
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2008-03-31
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 LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
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 mgDay and Olanzapine 10 mgDay 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 OROSÂ 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 mgday for 52 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None