ID

40859

Beschreibung

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

Stichworte

Versionen (1)
  1. 26.05.20 26.05.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

26. Mai 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hypertension, Pulmonary NCT01342952

Englisch

Eligibility Hypertension, Pulmonary NCT01342952

1 Formulare  
Inclusion Criteria
Beschreibung

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:
Beschreibung

Participation Clinical Trial Specified | Protocol Compliance Clinical Trial Specified

Datentyp

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;
Beschreibung

Visit Completion Clinical Trial Specified

Datentyp

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;
Beschreibung

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

Datentyp

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;
Beschreibung

Dose Reduced Required | Targeted Therapy Pulmonary arterial hypertension | ambrisentan

Datentyp

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.
Beschreibung

Ambrisentan therapy continued

Datentyp

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:
Beschreibung

Gender | Study Subject Participation Status Eligible

Datentyp

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,
Beschreibung

Gender | Childbearing Potential Absent

Datentyp

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).
Beschreibung

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

Datentyp

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.
Beschreibung

Informed Consent | Informed Consent Legal Guardian

Datentyp

boolean

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

Exclusion Criteria

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subjects who were withdrawn from ambrisentan in study amb112529;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

Ambrisentan Withdrawn Clinical Trial Specified

Datentyp

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;
Beschreibung

Protocol Compliance Lacking Clinical Trial Specified

Datentyp

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;
Beschreibung

Pregnancy | Breast Feeding

Datentyp

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;
Beschreibung

Renal Insufficiency Severe | Estimated creatine clearance

Datentyp

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;
Beschreibung

Body fluid retention

Datentyp

boolean

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

Anemia

Datentyp

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.
Beschreibung

Study Subject Participation Status | Clinical Trial | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3]
C0013230
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Ähnliche Modelle

Eligibility Hypertension, Pulmonary NCT01342952

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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