ID

22749

Description

A Study of the Dose Proportionality of Extended Release Paliperidone; ODM derived from: https://clinicaltrials.gov/show/NCT00791167

Link

https://clinicaltrials.gov/show/NCT00791167

Keywords

Versions (1)
  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 NCT00791167

English

Eligibility Schizophrenia NCT00791167

1 forms  
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
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
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
known drug allergy to risperidone, paliperidone, or any of its excipients
Description

hypersensitivity risperidone, paliperidone

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0073393
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0753678
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 [1,1]
C0019682
UMLS CUI [1,2]
C0019163
UMLS CUI [1,3]
C0019196
history of smoking or use of nicotine-containing substances within the last 2 months, as determined by medical history and/or volunteer's verbal report. volunteers must agree to refrain from use throughout the study
Description

tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before the first dose of study drug. exception for acetaminophen (paracetamol) or ibuprofen, which is allowed up to 3 days before first dose of study drug
Description

drugs and supplements, paracetamol, ibuprofen

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0242295
UMLS CUI [2]
C0000970
UMLS CUI [3]
C0020740
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Similar models

Eligibility Schizophrenia NCT00791167

1 forms
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])
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])
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)
hypersensitivity risperidone, paliperidone
Item
known drug allergy to risperidone, paliperidone, or any of its excipients
boolean
C0020517 (UMLS CUI [1,1])
C0073393 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0753678 (UMLS CUI [2,2])
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 [1,1])
C0019163 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
tobacco use
Item
history of smoking or use of nicotine-containing substances within the last 2 months, as determined by medical history and/or volunteer's verbal report. volunteers must agree to refrain from use throughout the study
boolean
C0543414 (UMLS CUI [1])
drugs and supplements, paracetamol, ibuprofen
Item
use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before the first dose of study drug. exception for acetaminophen (paracetamol) or ibuprofen, which is allowed up to 3 days before first dose of study drug
boolean
C0013227 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
C0000970 (UMLS CUI [2])
C0020740 (UMLS CUI [3])
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