Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00210769
Status:
COMPLETED
Last Update Posted:
2011-05-18
First Post:
2005-09-13
Brief Title:
A Study of the Long-term Safety and Tolerability and the Long-term Effectiveness of Extended-release Oral Paliperidone in Patients Diagnosed With Schizophrenia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Open-label Extension of A Randomized Double-Blind Placebo- and Active-Controlled Parallel-Group Dose-Response Study to Evaluate the Efficacy and Safety of 2 Fixed Dosages of Extended Release OROS Paliperidone 6 and 12 mgDay and Olanzapine 10 mgDay in Patients With Schizophrenia
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 this study is to evaluate the long-term safety and tolerability and the maintenance of effectiveness of a slow extended-release oral formulation of paliperidone administered once daily to patients diagnosed with schizophrenia
Detailed Description:
The controlled rate of drug delivery provided by the extended-release oral formulation of paliperidone may provide improved effectiveness and a reduced risk of certain adverse effects in patients with schizophrenia by avoiding peaks and troughs of drug levels in the blood This could in turn provide an improved quality of life and overall functioning for patients
This open-label study is an extension of a 6-week randomized double-blind parallel-group study in which the effectiveness and safety of 4 different oral treatments administered once daily are compared in patients with schizophrenia paliperidone 6 or 12 milligrams mg olanzapine 10 mg an approved treatment for schizophrenia or placebo Following the double-blind treatment phase eligible patients may enter this 52-week open-label extension with slow extended-release paliperidone with no comparison treatments In the open-label extension all patients regardless of their randomized treatment in the double-blind phase will begin on extended-release paliperidone 9 mg once daily Thereafter patients will be maintained on a flexible dosage of extended-release paliperidone throughout the 52-week study The dosage may be increased or decreased within this range in accordance with the clinical judgment of the investigator based on observations of patient response and tolerability Because flexible dosing more closely mimics clinical practice this design may provide more clinically relevant findings in the open-label settingThe final visit in the double-blind phase may serve as the initial visit for the open-label extension Study visits will occur at Day 4 and then weekly for the first 4 weeks Weeks 1 2 3 and 4 and then every 4 weeks through Week 52 or until early termination Evaluations of the safety and effectiveness of extended-release paliperidone treatment will be performed at scheduled times throughout the open-label extension Flexible dosage 3 6 9 or 12 milligrams mg extended-release paliperidone tablets administered orally once daily for 52 weeks following a 6-week double-blind study in which patients receive fixed oral doses of 6 mg or 12 mg extended-release paliperidone or olanzapine 10 mg
This open-label study is an extension of a 6-week randomized double-blind parallel-group study in which the effectiveness and safety of 4 different oral treatments administered once daily are compared in patients with schizophrenia paliperidone 6 or 12 milligrams mg olanzapine 10 mg an approved treatment for schizophrenia or placebo Following the double-blind treatment phase eligible patients may enter this 52-week open-label extension with slow extended-release paliperidone with no comparison treatments In the open-label extension all patients regardless of their randomized treatment in the double-blind phase will begin on extended-release paliperidone 9 mg once daily Thereafter patients will be maintained on a flexible dosage of extended-release paliperidone throughout the 52-week study The dosage may be increased or decreased within this range in accordance with the clinical judgment of the investigator based on observations of patient response and tolerability Because flexible dosing more closely mimics clinical practice this design may provide more clinically relevant findings in the open-label settingThe final visit in the double-blind phase may serve as the initial visit for the open-label extension Study visits will occur at Day 4 and then weekly for the first 4 weeks Weeks 1 2 3 and 4 and then every 4 weeks through Week 52 or until early termination Evaluations of the safety and effectiveness of extended-release paliperidone treatment will be performed at scheduled times throughout the open-label extension Flexible dosage 3 6 9 or 12 milligrams mg extended-release paliperidone tablets administered orally once daily for 52 weeks following a 6-week double-blind study in which patients receive fixed oral doses of 6 mg or 12 mg extended-release paliperidone or olanzapine 10 mg
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