ID

19095

Description

A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202); ODM derived from: https://clinicaltrials.gov/show/NCT00578786

Link

https://clinicaltrials.gov/show/NCT00578786

Keywords

Versions (1)
  1. 12/5/16 12/5/16 -
Uploaded on

December 5, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Pulmonary Arterial Hypertension NCT00578786

English

Eligibility Pulmonary Arterial Hypertension NCT00578786

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. subject must have completed week 12 of amb-320 (nct00423748) or amb-321 (nct00423202) or must have received placebo during amb-320 (nct00423748) or amb-321 (nct00423202) and met two or more early escape criteria;
Description

ambrisentan Completed | ambrisentan Placebos

Data type

boolean

Alias
UMLS CUI [1,1]
C1176329
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C1176329
UMLS CUI [2,2]
C0032042
2. subject must be competent to understand the information given in the institutional review board (irb) or independent ethics committee (iec) approved informed consent form and must sign the form prior to the initiation of any study procedures.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
3. female subject of childbearing potential must agree to use two reliable methods of contraception until study completion and for at least four weeks following their final study visit. reliable methods include: birth control pills/implants/injections, intrauterine devices (iuds), spermicide, diaphragms, or condoms.
Description

Childbearing Potential Contraceptive methods | Contraceptives, Oral | Contraceptive implant | Contraceptive injection | Intrauterine Devices | Vaginal Spermicides | Vaginal contraceptive diaphragm | Female Condoms

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0009905
UMLS CUI [3]
C1657106
UMLS CUI [4]
C1656586
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0087145
UMLS CUI [7]
C0042241
UMLS CUI [8]
C0221829
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects must have met the exclusion criteria of the amb-320 (nct00423748) and amb-321 (nct00423202)studies. in addition, a subject who meets any one of the following criteria is ineligible for participation in the study:
Description

ambrisentan Clinical Trials | Exclusion Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C1176329
UMLS CUI [1,2]
C0008976
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C1550543
1. subject receiving bosentan, sildenafil, or iv inotropes at any time within four weeks prior to the amb-320/321-e screening/randomization visit;
Description

bosentan | sildenafil | Cardiotonic Agents Intravenous

Data type

boolean

Alias
UMLS CUI [1]
C0252643
UMLS CUI [2]
C0529793
UMLS CUI [3,1]
C0007209
UMLS CUI [3,2]
C1522726
2. subject receiving chronic prostanoid therapy (epoprostenol, treprostinil, iloprost, beraprost, or any other investigational prostacyclin derivative) within four weeks prior to the amb-320/321-e screening/randomizationvisit;
Description

Prostaglandins chronic | Epoprostenol | Treprostinil | Iloprost | beraprost | Epoprostenol Derivative Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C0033554
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0033567
UMLS CUI [3]
C1145760
UMLS CUI [4]
C0079594
UMLS CUI [5]
C0053336
UMLS CUI [6,1]
C0033567
UMLS CUI [6,2]
C1527240
UMLS CUI [6,3]
C1517586
3. female subject who is pregnant or breastfeeding;
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. subject with cardiovascular, liver, renal, hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the investigator, may adversely affect the safety of the subject and/or efficacy of the study drug or severely limit the lifespan of the subject;
Description

Disease Affecting patient safety | Disease Affecting drug efficacy | Disease Limiting Life Expectancy | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Hematological Disease | Gastrointestinal Diseases | Immune System Diseases | Endocrine System Diseases | Metabolic Diseases | CNS disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0598333
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0023671
UMLS CUI [4]
C0007222
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0018939
UMLS CUI [8]
C0017178
UMLS CUI [9]
C0021053
UMLS CUI [10]
C0014130
UMLS CUI [11]
C0025517
UMLS CUI [12]
C0007682
5. subject who has demonstrated noncompliance with previous medical regimens;
Description

Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
6. subject who has a recent history of abusing alcohol or illicit drugs;
Description

Illicit Drugs abuse | Alcohol abuse

Data type

boolean

Alias
UMLS CUI [1,1]
C0086190
UMLS CUI [1,2]
C0013146
UMLS CUI [2]
C0085762
7. subject who has participated in a clinical study involving another investigational drug or device at any time within four weeks prior to the amb-320/321-e screening/randomization visit.
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
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Similar models

Eligibility Pulmonary Arterial Hypertension NCT00578786

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ambrisentan Completed | ambrisentan Placebos
Item
1. subject must have completed week 12 of amb-320 (nct00423748) or amb-321 (nct00423202) or must have received placebo during amb-320 (nct00423748) or amb-321 (nct00423202) and met two or more early escape criteria;
boolean
C1176329 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1176329 (UMLS CUI [2,1])
C0032042 (UMLS CUI [2,2])
Informed Consent
Item
2. subject must be competent to understand the information given in the institutional review board (irb) or independent ethics committee (iec) approved informed consent form and must sign the form prior to the initiation of any study procedures.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Contraceptives, Oral | Contraceptive implant | Contraceptive injection | Intrauterine Devices | Vaginal Spermicides | Vaginal contraceptive diaphragm | Female Condoms
Item
3. female subject of childbearing potential must agree to use two reliable methods of contraception until study completion and for at least four weeks following their final study visit. reliable methods include: birth control pills/implants/injections, intrauterine devices (iuds), spermicide, diaphragms, or condoms.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
C1657106 (UMLS CUI [3])
C1656586 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0087145 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
C0221829 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
ambrisentan Clinical Trials | Exclusion Criteria Fulfill
Item
subjects must have met the exclusion criteria of the amb-320 (nct00423748) and amb-321 (nct00423202)studies. in addition, a subject who meets any one of the following criteria is ineligible for participation in the study:
boolean
C1176329 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
bosentan | sildenafil | Cardiotonic Agents Intravenous
Item
1. subject receiving bosentan, sildenafil, or iv inotropes at any time within four weeks prior to the amb-320/321-e screening/randomization visit;
boolean
C0252643 (UMLS CUI [1])
C0529793 (UMLS CUI [2])
C0007209 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
Prostaglandins chronic | Epoprostenol | Treprostinil | Iloprost | beraprost | Epoprostenol Derivative Investigational
Item
2. subject receiving chronic prostanoid therapy (epoprostenol, treprostinil, iloprost, beraprost, or any other investigational prostacyclin derivative) within four weeks prior to the amb-320/321-e screening/randomizationvisit;
boolean
C0033554 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0033567 (UMLS CUI [2])
C1145760 (UMLS CUI [3])
C0079594 (UMLS CUI [4])
C0053336 (UMLS CUI [5])
C0033567 (UMLS CUI [6,1])
C1527240 (UMLS CUI [6,2])
C1517586 (UMLS CUI [6,3])
Pregnancy | Breast Feeding
Item
3. female subject who is pregnant or breastfeeding;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Disease Affecting patient safety | Disease Affecting drug efficacy | Disease Limiting Life Expectancy | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Hematological Disease | Gastrointestinal Diseases | Immune System Diseases | Endocrine System Diseases | Metabolic Diseases | CNS disorder
Item
4. subject with cardiovascular, liver, renal, hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the investigator, may adversely affect the safety of the subject and/or efficacy of the study drug or severely limit the lifespan of the subject;
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0598333 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0023671 (UMLS CUI [3,3])
C0007222 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0018939 (UMLS CUI [7])
C0017178 (UMLS CUI [8])
C0021053 (UMLS CUI [9])
C0014130 (UMLS CUI [10])
C0025517 (UMLS CUI [11])
C0007682 (UMLS CUI [12])
Compliance behavior Limited
Item
5. subject who has demonstrated noncompliance with previous medical regimens;
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Illicit Drugs abuse | Alcohol abuse
Item
6. subject who has a recent history of abusing alcohol or illicit drugs;
boolean
C0086190 (UMLS CUI [1,1])
C0013146 (UMLS CUI [1,2])
C0085762 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
7. subject who has participated in a clinical study involving another investigational drug or device at any time within four weeks prior to the amb-320/321-e screening/randomization visit.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
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