Status:
COMPLETED
A Study of QT and QTc Intervals in Patients Administered Immediate Release Paliperidone
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 inter...
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 d...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00791349
Start Date
February 1 2005
End Date
May 1 2005
Last Update
June 8 2011
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