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.
NCT00645307 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 235
Last updated 2011-06-08
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.
Conditions
Interventions
- DRUG
-
Extended Release OROS® Paliperidone
Sponsors & Collaborators
-
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
lead INDUSTRY
Principal Investigators
-
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-05-31
- Completion
- 2006-08-31
More Related Trials
-
Trial Evaluating the Efficacy and Safety of 2 Fixed Doses of Paliperidone Extended-Release (ER) Tablets in the Treatment of Adult Patients With Schizophrenia
NCT00077714 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Extended Release Extended-release (ER) OROS Paliperidone Tolerability, as Compared to Immediate-release (IR)Risperidone, in Patients With Schizophrenia
NCT00791232 ·Status: COMPLETED ·Phase: PHASE1
-
An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended-Release (ER) in Participants With Schizophrenia
NCT00757705 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.
NCT00397033 ·Status: COMPLETED ·Phase: PHASE3
-
An Efficacy and Safety Study of One Dosage of Paliperidone Extended Release (ER) in Treating Patients With Schizophrenia
NCT00524043 ·Status: COMPLETED ·Phase: PHASE4
-
Safety Study With Paliperidone ER Extended-Release (ER) Tablets in Geriatric Patients With Schizophrenia
NCT00085748 ·Status: COMPLETED ·Phase: PHASE3
-
A Bioequivalence Study of 15 mg ER OROS Paliperidone
NCT00892489 ·Status: COMPLETED ·Phase: PHASE1
-
An Exploratory Study on the Safety and Effectiveness of Paliperidone in Patients With Schizophrenia
NCT00257023 ·Status: COMPLETED ·Phase: PHASE2
-
A Safety and Pharmacokinetic Study of ER OROS Paliperidone in Pediatric Patients With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
NCT00796081 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia
NCT01662648 ·Status: COMPLETED ·Phase: PHASE3
-
An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia
NCT01009047 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Dose Proportionality of Extended Release Paliperidone
NCT00791167 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia
NCT00396565 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Compare the Effectiveness and Safety of Flexibly Varied Doses of Paliperidone Palmitate and Risperidone in Treating Patients With Schizophrenia
NCT00210717 ·Status: COMPLETED ·Phase: PHASE3
-
Paliperidone Palmitate Flexible Dosing in Schizophrenia
NCT01281527 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate Participants Satisfaction, Quality of Life and Effectiveness of Flexible-Dose of Paliperidone Extended Release (ER) in Participants With Schizophrenia, Previously Treated With Risperidone
NCT01010776 ·Status: COMPLETED ·Phase: PHASE4
-
Prevention of Relapse With Injectable Paliperidone Palmitate Versus Oral Antipsychotics
NCT01081769 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating and Comparing Single Dose and Multiple Dose Pharmacokinetics of ER OROS Paliperidone in Healthy Japanese and Caucasian Adults.
NCT00758030 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Flexibly Dosed Paliperidone Extended Release Tablets in Participants With Schizophrenia
NCT01541371 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety, Tolerability, and Treatment Response Study of Paliperidone Palmitate Administered to Patients With Schizophrenia
NCT01051531 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Paliperidone Enantiomer Disposition With Different Formulations and the Bioavailability of Immediate- and Extended-release Paliperidone
NCT00796276 ·Status: COMPLETED ·Phase: PHASE1
-
An Efficacy Study of Paliperidone for the Prevention of Relapse in Participants With Schizophrenia
NCT01662310 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia
NCT00210548 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia
NCT01606228 ·Status: COMPLETED ·Phase: PHASE3
-
An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended Release (ER) in Participants With Schizophrenia
NCT00460512 ·Status: COMPLETED ·Phase: PHASE3