A Study of QT and QTc Intervals in Patients Administered Immediate Release Paliperidone
Tracking Information | |||||
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First Received Date ICMJE | November 13, 2008 | ||||
Last Updated Date | June 6, 2011 | ||||
Start Date ICMJE | February 2005 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
To assess the cardiovascular safety of paliperidone in schizophrenic or schizoaffective patients, with particular attention to the length of the QT/QTc interval. Other ECG parameters, such as QRS and PR intervals, will also be carefully measured | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00791349 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
To explore the relationship between the pharmacokinetics of paliperidone and ECG parameters of interest, and to explore the safety and tolerability of paliperidone | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of QT and QTc Intervals in Patients Administered Immediate Release Paliperidone | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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 |
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Detailed Description | 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 |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Immediate release (IR) Paliperidone | ||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 141 | ||||
Completion Date | May 2005 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 50 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00791349 | ||||
Other Study ID Numbers ICMJE | CR004201 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
Verification Date | March 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |