Informações:
Falhas:
ID
20995
Descrição
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]; ODM derived from: https://clinicaltrials.gov/show/NCT00841568
Link
https://clinicaltrials.gov/show/NCT00841568
Palavras-chave
Versões (1)
- 02/04/2017 02/04/2017 -
Transferido a
2 de abril de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Autosomal Dominant Polycystic Kidney Disease NCT00841568
Eligibility Autosomal Dominant Polycystic Kidney Disease NCT00841568
- StudyEvent: Eligibility
Similar models
Eligibility Autosomal Dominant Polycystic Kidney Disease NCT00841568
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
preceding study
Item
patients who completed 5-day repeated administrations and the follow-up observation in the preceding study (156-04-001)
boolean
C2348568 (UMLS CUI [1])
preceding study administration safety confirmed
Item
patients in whom the safety of repeated administration was confirmed based on the investigator's reports from the preceding study (156-04-001)
boolean
C2348568 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0036043 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,2])
C0036043 (UMLS CUI [1,3])
serum creatinine
Item
patients with serum creatinine concentration of 2.5 mg/dl or higher at the screening examination
boolean
C0201976 (UMLS CUI [1])
complication
Item
patients with any of the following complications
boolean
C0009566 (UMLS CUI [1])
uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
cardiovascular or hepatic disease
Item
serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis)"
boolean
C0007222 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0023895 (UMLS CUI [2])
complications, medical history
Item
patients with any of the following complications or history thereof
boolean
C0009566 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0262926 (UMLS CUI [2])
drug hypersensitivity
Item
clinically significant drug allergies (anaphylaxis) or hypersensitivity (especially, hypersensitivity to benzazepine derivatives or suspected hypersensitivity thereto)
boolean
C0013182 (UMLS CUI [1])
informed consent, mental disorder
Item
inability to personally give consent due to a mental disease "
boolean
C0021430 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,2])
systolic blood pressure
Item
patients with sbp (in sitting position) <90 mm hg (at screening examination)
boolean
C0871470 (UMLS CUI [1])
bleeding tendency
Item
patients with history of massive bleeding or bleeding tendency
boolean
C1458140 (UMLS CUI [1])
drug or alcohol abuse
Item
patients with a history of drug or alcohol abuse within 6 months prior to the screening examination
boolean
C0038586 (UMLS CUI [1])
pregnancy, lactation, child bearing potential
Item
pregnant women, lactating women, or women who may become or plan to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C1960468 (UMLS CUI [3])
C0006147 (UMLS CUI [2])
C1960468 (UMLS CUI [3])
other investigational drug
Item
patients who received any investigational drug other than opc-41061 within 30 days prior to commencement of administration of opc-41061
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
participation not allowed
Item
any patient who, in the opinion of the principle investigator or attending investigators, should not participate in the study
boolean
C2348568 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,2])