ID

22750

Description

A Study of the Effects of Paroxetine on the Pharmacokinetics of Paliperidone ER; ODM derived from: https://clinicaltrials.gov/show/NCT00791713

Link

https://clinicaltrials.gov/show/NCT00791713

Keywords

  1. 6/11/17 6/11/17 -
Uploaded on

June 11, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Schizophrenia NCT00791713

Eligibility Schizophrenia NCT00791713

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
body mass index (weight [kg]/height [m2]) of 18 to 30 kg/m2, inclusive
Description

bmi

Data type

boolean

Alias
UMLS CUI [1]
C1305855
extensive metabolizer of cyp2d6. volunteers whose cyp2d6 genotype is unknown should have been phenotyped before the start of the study using dextromethorphan as a probe (i.e., have a dextromethorphan metabolic ratio <0.02, as determined according to the standard procedures of the study center)
Description

extensive metabolizer of cyp2d6, cyp2d6 genotype phenotyping using dextromethorphan as a probe

Data type

boolean

Alias
UMLS CUI [1]
C1827317
UMLS CUI [2,1]
C0057223
UMLS CUI [2,2]
C0017431
UMLS CUI [2,3]
C1285572
UMLS CUI [2,4]
C0011816
have a supine (after 5 minutes rest) blood pressure between 100 and 140 mmhg systolic, inclusive, and 50 and 90 mmhg diastolic, inclusive
Description

blood pressure supine

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes per day and has been following this pattern for at least 3 months before screening
Description

cigarettes per day, cigars per day, pipes per day

Data type

boolean

Alias
UMLS CUI [1]
C3694146
UMLS CUI [2,1]
C0678446
UMLS CUI [2,2]
C0439505
UMLS CUI [3,1]
C0240766
UMLS CUI [3,2]
C0439505
healthy on the basis of a prestudy physical examination, medical history, 12-lead ecg, and the laboratory results of serum chemistry, hematology, and urinalysis performed within 21 days before the first dose. if the results of the serum chemistry, hematology, or urinalysis testing are not within the laboratory's reference ranges, the volunteer can be included only if the investigator judges that the deviations are not clinically significant. for renal function tests, the values must be within the normal laboratory reference ranges
Description

physical examination | Medical History | 12 lead ECG | Laboratory Results; Serum Chemistry Measurement; Hematology finding; Urinalysis | Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0031809
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0430456
UMLS CUI [4,1]
C1254595
UMLS CUI [4,2]
C1883010
UMLS CUI [4,3]
C0474523
UMLS CUI [4,4]
C0042014
UMLS CUI [5]
C0232804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
poor or intermediate metabolizers of cyp2d6, as determined by genotyping or phenotyping using dextromethorphan
Description

poor or intermediate metabolizers of cyp2d6

Data type

boolean

Alias
UMLS CUI [1]
C3203680
UMLS CUI [2]
C3888904
known drug allergy to risperidone, paliperidone, paroxetine, or any of their excipients
Description

known drug allergy to risperidone, paliperidone, paroxetine

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0073393
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0753678
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0070122
known history of drug-induced dystonia
Description

drug-induced dystonia

Data type

boolean

Alias
UMLS CUI [1]
C0393595
recent history of alcohol or substance abuse
Description

substance use disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
relevant history or presence of any cardiovascular (including myocardial infarct or cardiac arrhythmia), respiratory, neurologic (including seizures), psychiatric, renal, hepatic, gastrointestinal (including surgeries, severe gastrointestinal narrowing, and malabsorption problems), endocrine, hematologic, or immunologic disease
Description

relevant history or presence of any cardiovascular (including myocardial infarct or cardiac arrhythmia), respiratory, neurologic (including seizures), psychiatric, renal, hepatic, gastrointestinal (including surgeries, severe gastrointestinal narrowing, and malabsorption problems), endocrine, hematologic, or immunologic disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0027051
UMLS CUI [1,3]
C0003811
UMLS CUI [2]
C0024115
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0036572
UMLS CUI [4]
C0004936
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0023895
UMLS CUI [7,1]
C0017178
UMLS CUI [7,2]
C0524722
UMLS CUI [7,3]
C0521587
UMLS CUI [7,4]
C0024523
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0018939
UMLS CUI [10]
C0021053
history of any cancer, with the exception of basal cell carcinoma
Description

history of any cancer, with the exception of basal cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2735088
UMLS CUI [2]
C0007117
at screening, has signs of autonomic dysfunction as indicated by a sustained decrease of >20 mmhg in systolic blood pressure or a decrease of >10 mmhg in diastolic blood pressure after standing for at least 2 minutes that is not associated with an increase of >15 beats per minute (bpm) in heart rate
Description

autonomic dysfunction, Systolic Pressure; Diastolic blood pressure; Standing position; heart rate

Data type

boolean

Alias
UMLS CUI [1,1]
C1145628
UMLS CUI [1,2]
C0871470
UMLS CUI [1,3]
C0428883
UMLS CUI [1,4]
C0018810
UMLS CUI [1,5]
C0231472
bradycardia (heart rate <50 bpm) as determined by screening 12-lead ecg
Description

bradycardia as determined by screening 12-lead ecg

Data type

boolean

Alias
UMLS CUI [1,1]
C0428977
UMLS CUI [1,2]
C0430456
a positive test result (or history of) for any of the serology tests (hepatitis b and c, and human immunodeficiency virus) at screening
Description

hiv, hep b, hep c

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196

Similar models

Eligibility Schizophrenia NCT00791713

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
bmi
Item
body mass index (weight [kg]/height [m2]) of 18 to 30 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
extensive metabolizer of cyp2d6, cyp2d6 genotype phenotyping using dextromethorphan as a probe
Item
extensive metabolizer of cyp2d6. volunteers whose cyp2d6 genotype is unknown should have been phenotyped before the start of the study using dextromethorphan as a probe (i.e., have a dextromethorphan metabolic ratio <0.02, as determined according to the standard procedures of the study center)
boolean
C1827317 (UMLS CUI [1])
C0057223 (UMLS CUI [2,1])
C0017431 (UMLS CUI [2,2])
C1285572 (UMLS CUI [2,3])
C0011816 (UMLS CUI [2,4])
blood pressure supine
Item
have a supine (after 5 minutes rest) blood pressure between 100 and 140 mmhg systolic, inclusive, and 50 and 90 mmhg diastolic, inclusive
boolean
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
cigarettes per day, cigars per day, pipes per day
Item
smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes per day and has been following this pattern for at least 3 months before screening
boolean
C3694146 (UMLS CUI [1])
C0678446 (UMLS CUI [2,1])
C0439505 (UMLS CUI [2,2])
C0240766 (UMLS CUI [3,1])
C0439505 (UMLS CUI [3,2])
physical examination | Medical History | 12 lead ECG | Laboratory Results; Serum Chemistry Measurement; Hematology finding; Urinalysis | Renal function
Item
healthy on the basis of a prestudy physical examination, medical history, 12-lead ecg, and the laboratory results of serum chemistry, hematology, and urinalysis performed within 21 days before the first dose. if the results of the serum chemistry, hematology, or urinalysis testing are not within the laboratory's reference ranges, the volunteer can be included only if the investigator judges that the deviations are not clinically significant. for renal function tests, the values must be within the normal laboratory reference ranges
boolean
C0031809 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0430456 (UMLS CUI [3])
C1254595 (UMLS CUI [4,1])
C1883010 (UMLS CUI [4,2])
C0474523 (UMLS CUI [4,3])
C0042014 (UMLS CUI [4,4])
C0232804 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
poor or intermediate metabolizers of cyp2d6
Item
poor or intermediate metabolizers of cyp2d6, as determined by genotyping or phenotyping using dextromethorphan
boolean
C3203680 (UMLS CUI [1])
C3888904 (UMLS CUI [2])
known drug allergy to risperidone, paliperidone, paroxetine
Item
known drug allergy to risperidone, paliperidone, paroxetine, or any of their excipients
boolean
C0020517 (UMLS CUI [1,1])
C0073393 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0753678 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0070122 (UMLS CUI [3,2])
drug-induced dystonia
Item
known history of drug-induced dystonia
boolean
C0393595 (UMLS CUI [1])
substance use disorder
Item
recent history of alcohol or substance abuse
boolean
C0038586 (UMLS CUI [1])
relevant history or presence of any cardiovascular (including myocardial infarct or cardiac arrhythmia), respiratory, neurologic (including seizures), psychiatric, renal, hepatic, gastrointestinal (including surgeries, severe gastrointestinal narrowing, and malabsorption problems), endocrine, hematologic, or immunologic disease
Item
relevant history or presence of any cardiovascular (including myocardial infarct or cardiac arrhythmia), respiratory, neurologic (including seizures), psychiatric, renal, hepatic, gastrointestinal (including surgeries, severe gastrointestinal narrowing, and malabsorption problems), endocrine, hematologic, or immunologic disease
boolean
C0018799 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C0003811 (UMLS CUI [1,3])
C0024115 (UMLS CUI [2])
C0027765 (UMLS CUI [3,1])
C0036572 (UMLS CUI [3,2])
C0004936 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0017178 (UMLS CUI [7,1])
C0524722 (UMLS CUI [7,2])
C0521587 (UMLS CUI [7,3])
C0024523 (UMLS CUI [7,4])
C0014130 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0021053 (UMLS CUI [10])
history of any cancer, with the exception of basal cell carcinoma
Item
history of any cancer, with the exception of basal cell carcinoma
boolean
C2735088 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
autonomic dysfunction, Systolic Pressure; Diastolic blood pressure; Standing position; heart rate
Item
at screening, has signs of autonomic dysfunction as indicated by a sustained decrease of >20 mmhg in systolic blood pressure or a decrease of >10 mmhg in diastolic blood pressure after standing for at least 2 minutes that is not associated with an increase of >15 beats per minute (bpm) in heart rate
boolean
C1145628 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,4])
C0231472 (UMLS CUI [1,5])
bradycardia as determined by screening 12-lead ecg
Item
bradycardia (heart rate <50 bpm) as determined by screening 12-lead ecg
boolean
C0428977 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
hiv, hep b, hep c
Item
a positive test result (or history of) for any of the serology tests (hepatitis b and c, and human immunodeficiency virus) at screening
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])

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