SchizophreniaPhase 1NCT00791349
A Study of QT and QTc Intervals in Patients Administered Immediate Release Paliperidone
A Phase 1 study testing Immediate release (IR) Paliperidone in people with Schizophrenia and Schizoaffective Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Immediate release (IR) Paliperidone
- How many people
- 141 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to May 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must have a diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV criteria, with no exacerbation of psychosis for at least 3 months prior to screening
- Patients must have a normal 12-lead ECG at screening and on Day -1, including: Normal sinus rhythm (heart rate between 50 and 100 beats per minute)
- QTcB interval < = 430 msec for men, < = 450 msec for women
- QRS interval <110 msec, PR interval < 200 msec
- Patients must weigh > = 50 kg ( > = 110 lb), with a body mass index > = 18 and < = 35 kg/m2
- Female patients must be postmenopausal (for at least 1 year), surgically sterile, or practicing an effective non-hormonal method of birth control (e.g., intrauterine device, double-barrier method, male partner sterilization, abstinence) before entry and throughout the study
- must have a negative serum beta human chorionic gonadotropin pregnancy test at screening
- and must have a negative urine pregnancy test within 24 hours before Day 1 of the randomization period.
Who cannot join
- Patient meets DSM-IV criteria for psychoactive substance dependence in the 3 months prior to screening
- Patient is at risk for suicidal or violent behavior, as judged by the investigator: Patient has a clinically significant abnormality on ECG at screening or on Day -1 of the study
- Patient has a heart rhythm disturbance that is known or suggested by history or that is demonstrated on ECG at screening
- Patient has a blood pressure outside of the normal range (supine systolic blood pressure <90 or >140 mmHg and/or diastolic blood pressure <60 or > 90 mmHg)
- Patient has unusual T-wave morphology in a majority of leads of the ECG (such as bifid T waves, low T waves) or prominent U waves at screening: Patient has a history of additional risk factors for torsade de pointes, such as heart failure, hypokalemia, family history of known long QT interval syndrome, or sudden unexplained death at a young age ( < = 40 years) in a first-degree relative (i.e., biological parent, sibling, or offspring)
- Patient has a relevant history of any significant and/or unstable cardiovascular, respiratory (including bronchial asthma), neurologic (including seizures or significant cerebrovascular disease), renal, hepatic, endocrine, immunologic, ophthalmologic, hematological, or other systemic disease.
About this 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
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
Read the 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
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Immediate release (IR) Paliperidone
- Keywords
- Schizophrenia, Schizoaffective Disorder, Mood Disorders, Antipsychotic drugs, Cardiovascular, Immediate release (IR) Paliperidone
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate release (IR) PaliperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (1)
To explore the relationship between the pharmacokinetics of paliperidone and ECG parameters of interest, and to explore the safety and tolerability of paliperidone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startFeb 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791349
- Sponsor's protocol ID
- CR004201
- Status last verified
- Mar 2010
- First submitted
- 13 Nov 2008
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00791349
- Acronym / sponsor ID
- CR004201
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Schizoaffective Disorder, Mood Disorders, Antipsychotic drugs, Cardiovascular, Immediate release (IR) Paliperidone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Feb 2005
- Study completion
- May 2005 (actual)
- First posted
- 14 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients must have a diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV criteria, with no exacerbation of psychosis for at least 3 months prior to screening
- Patients must have a normal 12-lead ECG at screening and on Day -1, including: Normal sinus rhythm (heart rate between 50 and 100 beats per minute)
- QTcB interval < = 430 msec for men, < = 450 msec for women
- QRS interval <110 msec, PR interval < 200 msec
- Patients must weigh > = 50 kg ( > = 110 lb), with a body mass index > = 18 and < = 35 kg/m2
Key exclusion criteria (6 listed)
- Patient meets DSM-IV criteria for psychoactive substance dependence in the 3 months prior to screening
- Patient is at risk for suicidal or violent behavior, as judged by the investigator: Patient has a clinically significant abnormality on ECG at screening or on Day -1 of the study
- Patient has a heart rhythm disturbance that is known or suggested by history or that is demonstrated on ECG at screening
- Patient has a blood pressure outside of the normal range (supine systolic blood pressure <90 or >140 mmHg and/or diastolic blood pressure <60 or > 90 mmHg)
- Patient has unusual T-wave morphology in a majority of leads of the ECG (such as bifid T waves, low T waves) or prominent U waves at screening: Patient has a history of additional risk factors for torsade de pointes, such as heart failure, hypokalemia, family history of known long QT interval syndrome, or sudden unexplained death at a young age ( < = 40 years) in a first-degree relative (i.e., biological parent, sibling, or offspring)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate release (IR) Paliperidone | Drug | – |
Primary outcome
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
1 secondary outcome
To explore the relationship between the pharmacokinetics of paliperidone and ECG parameters of interest, and to explore the safety and tolerability of paliperidone
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- A study of QT and QTc intervals in patients administered immediate release paliperidoneLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Immediate release (IR) Paliperidone in people with Schizophrenia and Schizoaffective Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.