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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00791349 |
The purpose of this study is to assess the cardiovascular safety of paliperidone in patients with schizophrenia or schizoaffective disorder, with particular attention to the length of the QT/QTc interval, to measure and review other electrocardiogram (ECG) parameters, such as QRS and PR intervals, to explore the relationship between the pharmacokinetics of paliperidone and ECG parameters of interest, and to explore the safety and tolerability of paliperidone
Condition | Intervention | Phase |
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Schizoaffective Disorder Schizophrenia |
Drug: Immediate release (IR) Paliperidone |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Pharmacodynamics Study |
Official Title: | A Placebo- and Positive-Controlled, Randomized Study Evaluating QT and QTc Intervals Following Administration of Immediate-Release Paliperidone in Subjects With Schizophrenia or Schizoaffective Disorder |
Estimated Enrollment: | 100 |
Study Start Date: | February 2005 |
Study Completion Date: | May 2005 |
This is a multicenter, placebo- and positive-controlled, randomized study consisting of 3 periods: a screening period of up to 14 days (including a 5-day washout period), a double-blind period of 10 days (including the treatment phase [Days 1 to 8] and the posttreatment phase [Days 9 and 10]), and an end-of-study evaluation.
Eligible patients will be randomly assigned to treatment with either paliperidone or moxifloxacin. Patients randomly assigned to receive paliperidone will receive placebo on Day 1, paliperidone 4 mg on Day 2, paliperidone 6 mg on Day 3, and paliperidone 8 mg on Days 4 through 8. Patients assigned to receive moxifloxacin will receive placebo on Days 1 through 7 and moxifloxacin 400 mg on Day 8. The moxifloxacin treatment group will provide a concurrent active control to confirm that the study is adequate to detect a drug effect (i.e., assay sensitivity) on QTc interval. Baseline ECGs will be recorded on the last day of the washout period (Day 1). Serial time matched 12 lead ECG triplicate readings will be recorded on Days 1, 2, 3, 4, 5 (predose), 8, 9, and 10. This study is being conducted to thoroughly assess potential QT/QTc interval changes following administration of paliperidone. The results from this safety study, along with the ECG results from all paliperidone clinical studies, will be used in the evaluation of the cardiovascular safety of paliperidone.
Paliperidone IR orally once daily: 4 mg on Day 2, 6 mg on Day 3, and 8 mg on Days 4 through 8; Active control: a single oral dose of moxifloxacin 400 mg on Day 8
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR004201 |
Study First Received: | November 13, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00791349 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Schizoaffective Disorder Schizophrenia Cardiovascular |
Immediate release (IR) Paliperidone Mood Disorders Antipsychotic drugs |
Schizophrenia Tranquilizing Agents Mental Disorders Psychotropic Drugs Risperidone Mood Disorders |
Central Nervous System Depressants 9-hydroxy-risperidone Psychotic Disorders Antipsychotic Agents Schizophrenia and Disorders with Psychotic Features |
Disease Tranquilizing Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants 9-hydroxy-risperidone Antipsychotic Agents Pharmacologic Actions |
Schizophrenia Pathologic Processes Mental Disorders Therapeutic Uses Psychotic Disorders Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |