ID

34424

Description

A Pharmacokinetic Substudy of the TDE-PH-304 Protocol; ODM derived from: https://clinicaltrials.gov/show/NCT01934582

Link

https://clinicaltrials.gov/show/NCT01934582

Keywords

Versions (1)
  1. 1/17/19 1/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT01934582

English

Eligibility Pulmonary Arterial Hypertension NCT01934582

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1) only subjects who are eligible for and have entered into protocol tde-ph-304 may participate in this substudy.
Description

Study Subject Participation Status | Protocol Specified

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0205369
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. the subject must voluntarily give informed consent to participate in the substudy.
Description

Informed Consent Voluntary

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439656
2. no dose changes to study drug are made within 5 days of the pharmacokinetic (pk)substudy visits.
Description

Investigational New Drugs Dose Change

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0392747
3. no additions or deletions to concurrent medications are made within 7 days of the pharmacokinetic substudy visit. note: changes to diuretics and/or anticoagulants are permitted.
Description

Pharmaceutical Preparations Additional | Pharmaceutical Preparations Discontinuation | Diuretics Change allowed | Anticoagulants Change allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1524062
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C0012798
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C0003280
UMLS CUI [4,2]
C0392747
UMLS CUI [4,3]
C0683607
4. the preceding evening dose of study drug should have been taken 9 to 13 hours prior to the bid dose and 6-10 hours prior to the tid morning dose of study drug to ensure a trough level of study drug for pk sampling.
Description

Investigational New Drug Level | Evening Dose | Morning Dose | Pharmacokinetics Sampling

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0441889
UMLS CUI [2,1]
C0587117
UMLS CUI [2,2]
C0178602
UMLS CUI [3,1]
C0332170
UMLS CUI [3,2]
C0178602
UMLS CUI [4,1]
C0031328
UMLS CUI [4,2]
C0870078
5. subject dosing of study drug on the day of pk sampling must be observed in the clinic by study personnel.
Description

Investigational New Drug Dosage | Pharmacokinetics Sampling

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0178602
UMLS CUI [2,1]
C0031328
UMLS CUI [2,2]
C0870078
6. subject has not experienced a significant loss of blood (> 450 ml) within the last 6 weeks of the pharmacokinetic substudy visit.
Description

Blood Loss Amount

Data type

boolean

Alias
UMLS CUI [1,1]
C3163616
UMLS CUI [1,2]
C1265611
7. the subject must not be receiving any cyp 2c8 inducers or inhibitors
Description

CYP2C8 Inducers | CYP2C8 Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C3850048
UMLS CUI [2]
C3850061
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Similar models

Eligibility Pulmonary Arterial Hypertension NCT01934582

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status | Protocol Specified
Item
1) only subjects who are eligible for and have entered into protocol tde-ph-304 may participate in this substudy.
boolean
C2348568 (UMLS CUI [1])
C2348563 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Voluntary
Item
1. the subject must voluntarily give informed consent to participate in the substudy.
boolean
C0021430 (UMLS CUI [1,1])
C0439656 (UMLS CUI [1,2])
Investigational New Drugs Dose Change
Item
2. no dose changes to study drug are made within 5 days of the pharmacokinetic (pk)substudy visits.
boolean
C0013230 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
Pharmaceutical Preparations Additional | Pharmaceutical Preparations Discontinuation | Diuretics Change allowed | Anticoagulants Change allowed
Item
3. no additions or deletions to concurrent medications are made within 7 days of the pharmacokinetic substudy visit. note: changes to diuretics and/or anticoagulants are permitted.
boolean
C0013227 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0012798 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0003280 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Investigational New Drug Level | Evening Dose | Morning Dose | Pharmacokinetics Sampling
Item
4. the preceding evening dose of study drug should have been taken 9 to 13 hours prior to the bid dose and 6-10 hours prior to the tid morning dose of study drug to ensure a trough level of study drug for pk sampling.
boolean
C0013230 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C0587117 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0332170 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0031328 (UMLS CUI [4,1])
C0870078 (UMLS CUI [4,2])
Investigational New Drug Dosage | Pharmacokinetics Sampling
Item
5. subject dosing of study drug on the day of pk sampling must be observed in the clinic by study personnel.
boolean
C0013230 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0031328 (UMLS CUI [2,1])
C0870078 (UMLS CUI [2,2])
Blood Loss Amount
Item
6. subject has not experienced a significant loss of blood (> 450 ml) within the last 6 weeks of the pharmacokinetic substudy visit.
boolean
C3163616 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
CYP2C8 Inducers | CYP2C8 Inhibitors
Item
7. the subject must not be receiving any cyp 2c8 inducers or inhibitors
boolean
C3850048 (UMLS CUI [1])
C3850061 (UMLS CUI [2])
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