ID

31696

Description

A Study to Evaluate GSK1325760A - a Long-Term Extension Study; ODM derived from: https://clinicaltrials.gov/show/NCT00554619

Link

https://clinicaltrials.gov/show/NCT00554619

Keywords

Versions (1)
  1. 9/21/18 9/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT00554619

English

Eligibility Pulmonary Arterial Hypertension NCT00554619

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who complete the 24-week administration of the phase ii/iii study (study no.amb107816)
Description

Administration of medication Complete | Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C3469597
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
subjects who are assessed that the long-term extension administration of gsk1325760a is appropriate in the judgement of the investigator or subinvestigator
Description

Patients Appropriate Ambrisentan Long-term drug therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C1176329
UMLS CUI [1,4]
C0420257
subjects who request the long-term extension administration of gsk1325760a, and agree to newly sign the informed consent form
Description

Ambrisentan Long-term drug therapy Requested by patient | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C1176329
UMLS CUI [1,2]
C0420257
UMLS CUI [1,3]
C0332153
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have been withdrawn from the phase ii/iii study.
Description

Patient withdrawn from trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0205369
female subjects who wish to become pregnant.
Description

Gender Planned Pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0032992
treatment with other pah medication is needed.
Description

Pharmaceutical Preparations Other Pulmonary arterial hypertension

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2973725
a worsening of 2 or more levels of the who functional classification (see appendix 2.1) comparing with the baseline of phase ii/iii study (study no.amb107816).
Description

Worsening Level Quantity WHO classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0332271
UMLS CUI [1,2]
C0441889
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C4267671
worsening of right ventricular failure (e.g. as indicated by increased jugular venous pressure, new/worsened hepatomegaly, ascites, or peripheral edema) during phase ii/iii study (study no.amb107816).
Description

Worsening Right ventricular failure | Raised jugular venous pressure | HEPATOMEGALY NEW | Hepatomegaly Worsened | Ascites | Peripheral edema

Data type

boolean

Alias
UMLS CUI [1,1]
C0332271
UMLS CUI [1,2]
C2939447
UMLS CUI [2]
C0520861
UMLS CUI [3]
C0744872
UMLS CUI [4,1]
C0019209
UMLS CUI [4,2]
C1457868
UMLS CUI [5]
C0003962
UMLS CUI [6]
C0085649
rapidly progressing cardiac, hepatic or renal failure during phase ii/iii study (study no.amb107816).
Description

Heart failure Rapidly progressive | Liver Failure Rapidly progressive | Kidney Failure Rapidly progressive

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1838681
UMLS CUI [2,1]
C0085605
UMLS CUI [2,2]
C1838681
UMLS CUI [3,1]
C0035078
UMLS CUI [3,2]
C1838681
participation to the long-term extension study is considered as inappropriate in the judgment of the investigator or subinvestigator.
Description

Study Subject Participation Status Inappropriate | Clinical Trial Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0443252
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Similar models

Eligibility Pulmonary Arterial Hypertension NCT00554619

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Administration of medication Complete | Clinical Trial Specified
Item
subjects who complete the 24-week administration of the phase ii/iii study (study no.amb107816)
boolean
C3469597 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Patients Appropriate Ambrisentan Long-term drug therapy
Item
subjects who are assessed that the long-term extension administration of gsk1325760a is appropriate in the judgement of the investigator or subinvestigator
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1176329 (UMLS CUI [1,3])
C0420257 (UMLS CUI [1,4])
Ambrisentan Long-term drug therapy Requested by patient | Informed Consent
Item
subjects who request the long-term extension administration of gsk1325760a, and agree to newly sign the informed consent form
boolean
C1176329 (UMLS CUI [1,1])
C0420257 (UMLS CUI [1,2])
C0332153 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Patient withdrawn from trial Specified
Item
subjects who have been withdrawn from the phase ii/iii study.
boolean
C0422727 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Gender Planned Pregnancy
Item
female subjects who wish to become pregnant.
boolean
C0079399 (UMLS CUI [1,1])
C0032992 (UMLS CUI [1,2])
Pharmaceutical Preparations Other Pulmonary arterial hypertension
Item
treatment with other pah medication is needed.
boolean
C0013227 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2973725 (UMLS CUI [1,3])
Worsening Level Quantity WHO classification
Item
a worsening of 2 or more levels of the who functional classification (see appendix 2.1) comparing with the baseline of phase ii/iii study (study no.amb107816).
boolean
C0332271 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C4267671 (UMLS CUI [1,4])
Worsening Right ventricular failure | Raised jugular venous pressure | HEPATOMEGALY NEW | Hepatomegaly Worsened | Ascites | Peripheral edema
Item
worsening of right ventricular failure (e.g. as indicated by increased jugular venous pressure, new/worsened hepatomegaly, ascites, or peripheral edema) during phase ii/iii study (study no.amb107816).
boolean
C0332271 (UMLS CUI [1,1])
C2939447 (UMLS CUI [1,2])
C0520861 (UMLS CUI [2])
C0744872 (UMLS CUI [3])
C0019209 (UMLS CUI [4,1])
C1457868 (UMLS CUI [4,2])
C0003962 (UMLS CUI [5])
C0085649 (UMLS CUI [6])
Heart failure Rapidly progressive | Liver Failure Rapidly progressive | Kidney Failure Rapidly progressive
Item
rapidly progressing cardiac, hepatic or renal failure during phase ii/iii study (study no.amb107816).
boolean
C0018801 (UMLS CUI [1,1])
C1838681 (UMLS CUI [1,2])
C0085605 (UMLS CUI [2,1])
C1838681 (UMLS CUI [2,2])
C0035078 (UMLS CUI [3,1])
C1838681 (UMLS CUI [3,2])
Study Subject Participation Status Inappropriate | Clinical Trial Long-term
Item
participation to the long-term extension study is considered as inappropriate in the judgment of the investigator or subinvestigator.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0443252 (UMLS CUI [2,2])
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