Status:
COMPLETED
A 52 Week Open Label Extension Trial Following the Recurrence Prevention Study R076477-SCH-301 to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study was an Open Label Extension to the recurrence prevention study to evaluate long-term safety and tolerability of paliperidone ER in subjects with schizophrenia.
Detailed Description
The primary objective of the open-label extension was the long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia. In addition, ...
Eligibility Criteria
Inclusion
- Subjects who had experienced a recurrence event during the double blind phase of Study R076477-SCH-301
- Remained recurrence free until the end of the double-blind phase, or were in the run-in or stabilization phases when the study was terminated
- Who signed the informed consent for the open-label extension
- And who the investigator agreed that open-label treatment was in the best interest of the subject were eligible to participate in the open-label extension
Exclusion
- Not eligible to enter the open-label phase if believed to be at significant risk for suicidal or violent behavior during the open-label extension trial
- Were pregnant or had received an injection of a depot antipsychotic since entry into the preceding double-blind phase
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT00645307
Start Date
May 1 2004
End Date
August 1 2006
Last Update
June 8 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.