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])
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])