ID

20995

Descripción

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

Palabras clave

Versiones (1)
  1. 2/4/17 2/4/17 -
Subido en

2 de abril de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Autosomal Dominant Polycystic Kidney Disease NCT00841568

Inglés

Eligibility Autosomal Dominant Polycystic Kidney Disease NCT00841568

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who completed 5-day repeated administrations and the follow-up observation in the preceding study (156-04-001)
Descripción

preceding study

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
patients in whom the safety of repeated administration was confirmed based on the investigator's reports from the preceding study (156-04-001)
Descripción

preceding study administration safety confirmed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0036043
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with serum creatinine concentration of 2.5 mg/dl or higher at the screening examination
Descripción

serum creatinine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
patients with any of the following complications
Descripción

complication

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009566
uncontrolled hypertension
Descripción

uncontrolled hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1868885
serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis)"
Descripción

cardiovascular or hepatic disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0023895
patients with any of the following complications or history thereof
Descripción

complications, medical history

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009566
UMLS CUI [2]
C0262926
clinically significant drug allergies (anaphylaxis) or hypersensitivity (especially, hypersensitivity to benzazepine derivatives or suspected hypersensitivity thereto)
Descripción

drug hypersensitivity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013182
inability to personally give consent due to a mental disease "
Descripción

informed consent, mental disorder

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0004936
patients with sbp (in sitting position) <90 mm hg (at screening examination)
Descripción

systolic blood pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0871470
patients with history of massive bleeding or bleeding tendency
Descripción

bleeding tendency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1458140
patients with a history of drug or alcohol abuse within 6 months prior to the screening examination
Descripción

drug or alcohol abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
pregnant women, lactating women, or women who may become or plan to become pregnant
Descripción

pregnancy, lactation, child bearing potential

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C1960468
patients who received any investigational drug other than opc-41061 within 30 days prior to commencement of administration of opc-41061
Descripción

other investigational drug

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
any patient who, in the opinion of the principle investigator or attending investigators, should not participate in the study
Descripción

participation not allowed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0683607
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Similar models

Eligibility Autosomal Dominant Polycystic Kidney Disease NCT00841568

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
complications, medical history
Item
patients with any of the following complications or history thereof
boolean
C0009566 (UMLS CUI [1])
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])
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])
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])
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])
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