Study Subject Participation Status | Protocol Specified
Item
must have participated in protocol 328 (without discontinuation due to a study drug related ae).
boolean
C2348568 (UMLS CUI [1])
C2348563 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Informed Consent
Item
must sign an informed consent prior to initiating any stus dy procedures.
boolean
C0021430 (UMLS CUI [1])
Indication for Candesartan cilexetil Formulation Liquid Oral | Hypertensive disease control
Item
have, in the opinion of the investigator, an on-going clinical indication for oral liquid formulation of candesartan cilexetil to control hypertension
boolean
C0392360 (UMLS CUI [1,1])
C0527379 (UMLS CUI [1,2])
C0524527 (UMLS CUI [1,3])
C1697794 (UMLS CUI [1,4])
C1527415 (UMLS CUI [1,5])
C0020538 (UMLS CUI [2,1])
C0243148 (UMLS CUI [2,2])
Body Weight
Item
weight ≥ 10 kg and ≤ 40 kg.
boolean
C0005910 (UMLS CUI [1])
Situation Interferes with Study Subject Participation Status | Medical condition Interferes with Study Subject Participation Status | Decreased renal function Interferes with Study Subject Participation Status | Laboratory test result abnormal Interferes with Study Subject Participation Status
Item
any situation, clinical condition (such as clinically significant declining renal function) or laboratory abnormality that, in the opinion of the investigator or sponsor, may interfere with the subject's participation in the study.
boolean
C0748872 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0232807 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0438215 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
Estimated Glomerular Filtration Rate Transplantation Absent | Estimated Glomerular Filtration Rate Transplantation | Formula Schwartz
Item
estimated glomerular filtration rate (gfr) <30 ml/min/1.73m2 for non-transplant patients and <40 ml/min/1.73m2 for transplant patients based on the schwartz formula (schwartz et al 1987) as determined at enrollment into study 328.
boolean
C3811844 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3811844 (UMLS CUI [2,1])
C0040732 (UMLS CUI [2,2])
C1980037 (UMLS CUI [3])
Liver Dysfunction | Liver diseases | Chronic liver disease Associated with Elevated liver enzymes persistent
Item
impaired liver function defined as either acute liver disease or chronic liver disease with persistently elevated liver enzyme values judged clinically significant by the investigator.
boolean
C0086565 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0341439 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0235996 (UMLS CUI [3,3])
C0205322 (UMLS CUI [3,4])
Pharmaceutical Preparations Combination Candesartan cilexetil | Patient affected Negative
Item
currently using any medications that, in the opinion of the investigator could negatively affect the subject when given together with candesartan cilexetil.
boolean
C0013227 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C0527379 (UMLS CUI [1,3])
C0522476 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])