ID

40859

Description

Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529; ODM derived from: https://clinicaltrials.gov/show/NCT01342952

Link

https://clinicaltrials.gov/show/NCT01342952

Keywords

Versions (1)
  1. 5/26/20 5/26/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 26, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hypertension, Pulmonary NCT01342952

English

Eligibility Hypertension, Pulmonary NCT01342952

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have participated in and complied, to the best of their ability, with the protocol for amb112529 and have met one of the following:
Description

Participation Clinical Trial Specified | Protocol Compliance Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205369
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205369
1. completed the week 24 visit in amb112529;
Description

Visit Completion Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205369
2. required additional targeted treatment for pah due to inadequate response to the current treatment or worsening of their clinical condition prior to week 24 in amb112529;
Description

Requirement Targeted Therapy Pulmonary arterial hypertension | Response to treatment Inadequate | Worsening Condition Clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C2985566
UMLS CUI [1,3]
C2973725
UMLS CUI [2,1]
C0521982
UMLS CUI [2,2]
C0205412
UMLS CUI [3,1]
C0332271
UMLS CUI [3,2]
C0348080
UMLS CUI [3,3]
C0205210
3. required reduction in dose of baseline targeted treatment for pah after ambrisentan was added to the treatment regimen;
Description

Dose Reduced Required | Targeted Therapy Pulmonary arterial hypertension | ambrisentan

Data type

boolean

Alias
UMLS CUI [1,1]
C1707814
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C2973725
UMLS CUI [3]
C1176329
4. in the opinion of the investigator, continued treatment with ambrisentan is warranted.
Description

Ambrisentan therapy continued

Data type

boolean

Alias
UMLS CUI [1,1]
C1176329
UMLS CUI [1,2]
C3494713
a female is eligible to participate in this study, as assessed by the investigator, if she is of:
Description

Gender | Study Subject Participation Status Eligible

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C1548635
1. non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
Description

Gender | Childbearing Potential Absent

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
2. child-bearing potential - has a negative pregnancy test and is not lactating and, if sexually active, agrees to continue to use 2 reliable methods of contraception until study completion and for at least 30 days following the last dose of study drug (reliable methods of contraception are listed in appendix 2).
Description

Childbearing Potential Pregnancy test negative | Childbearing Potential Breast Feeding Absent | Childbearing Potential Sexually active Contraceptive methods Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0006147
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
C0700589
UMLS CUI [3,4]
C1265611
subject or subject's legal guardian is able and willing to give written informed consent. as part of the consent, female subjects of childbearing potential will be informed of the risk of teratogenicity and will need to be counselled in a developmentally appropriate manner on the importance of pregnancy prevention; and male subjects will need to be informed of potential risk of testicular tubular atrophy and aspermia.
Description

Informed Consent | Informed Consent Legal Guardian

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who were withdrawn from ambrisentan in study amb112529;
Description

Ambrisentan Withdrawn Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C1176329
UMLS CUI [1,2]
C1707825
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205369
subjects who did not comply with the protocol in study amb112529;
Description

Protocol Compliance Lacking Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205369
female subjects who are pregnant or breastfeeding;
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects with severe renal impairment (estimated creatinine clearance <30 ml/min assessed within the previous 45 days) at the point of transition from study amb112529 into this study;
Description

Renal Insufficiency Severe | Estimated creatine clearance

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1273051
subject with clinically significant fluid retention in the opinion of the investigator;
Description

Body fluid retention

Data type

boolean

Alias
UMLS CUI [1]
C0268000
subject with clinically significant anaemia in the opinion of the investigator;
Description

Anemia

Data type

boolean

Alias
UMLS CUI [1]
C0002871
subjects who are to enter another clinical trial or be treated with another investigational product after exiting study amb112529.
Description

Study Subject Participation Status | Clinical Trial | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3]
C0013230
Back to the top of the page

Similar models

Eligibility Hypertension, Pulmonary NCT01342952

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Participation Clinical Trial Specified | Protocol Compliance Clinical Trial Specified
Item
have participated in and complied, to the best of their ability, with the protocol for amb112529 and have met one of the following:
boolean
C0679823 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C0525058 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Visit Completion Clinical Trial Specified
Item
1. completed the week 24 visit in amb112529;
boolean
C1512346 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
Requirement Targeted Therapy Pulmonary arterial hypertension | Response to treatment Inadequate | Worsening Condition Clinical
Item
2. required additional targeted treatment for pah due to inadequate response to the current treatment or worsening of their clinical condition prior to week 24 in amb112529;
boolean
C1514873 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
C2973725 (UMLS CUI [1,3])
C0521982 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0332271 (UMLS CUI [3,1])
C0348080 (UMLS CUI [3,2])
C0205210 (UMLS CUI [3,3])
Dose Reduced Required | Targeted Therapy Pulmonary arterial hypertension | ambrisentan
Item
3. required reduction in dose of baseline targeted treatment for pah after ambrisentan was added to the treatment regimen;
boolean
C1707814 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C2985566 (UMLS CUI [2,1])
C2973725 (UMLS CUI [2,2])
C1176329 (UMLS CUI [3])
Ambrisentan therapy continued
Item
4. in the opinion of the investigator, continued treatment with ambrisentan is warranted.
boolean
C1176329 (UMLS CUI [1,1])
C3494713 (UMLS CUI [1,2])
Gender | Study Subject Participation Status Eligible
Item
a female is eligible to participate in this study, as assessed by the investigator, if she is of:
boolean
C0079399 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
Gender | Childbearing Potential Absent
Item
1. non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Childbearing Potential Pregnancy test negative | Childbearing Potential Breast Feeding Absent | Childbearing Potential Sexually active Contraceptive methods Quantity
Item
2. child-bearing potential - has a negative pregnancy test and is not lactating and, if sexually active, agrees to continue to use 2 reliable methods of contraception until study completion and for at least 30 days following the last dose of study drug (reliable methods of contraception are listed in appendix 2).
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Informed Consent | Informed Consent Legal Guardian
Item
subject or subject's legal guardian is able and willing to give written informed consent. as part of the consent, female subjects of childbearing potential will be informed of the risk of teratogenicity and will need to be counselled in a developmentally appropriate manner on the importance of pregnancy prevention; and male subjects will need to be informed of potential risk of testicular tubular atrophy and aspermia.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Ambrisentan Withdrawn Clinical Trial Specified
Item
subjects who were withdrawn from ambrisentan in study amb112529;
boolean
C1176329 (UMLS CUI [1,1])
C1707825 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
Protocol Compliance Lacking Clinical Trial Specified
Item
subjects who did not comply with the protocol in study amb112529;
boolean
C0525058 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
Pregnancy | Breast Feeding
Item
female subjects who are pregnant or breastfeeding;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Renal Insufficiency Severe | Estimated creatine clearance
Item
subjects with severe renal impairment (estimated creatinine clearance <30 ml/min assessed within the previous 45 days) at the point of transition from study amb112529 into this study;
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1273051 (UMLS CUI [2])
Body fluid retention
Item
subject with clinically significant fluid retention in the opinion of the investigator;
boolean
C0268000 (UMLS CUI [1])
Anemia
Item
subject with clinically significant anaemia in the opinion of the investigator;
boolean
C0002871 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trial | Investigational New Drugs
Item
subjects who are to enter another clinical trial or be treated with another investigational product after exiting study amb112529.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial