ID

31499

Description

Tolvaptan Phase 3 Efficacy and Safety Study in ADPKD; ODM derived from: https://clinicaltrials.gov/show/NCT00428948

Link

https://clinicaltrials.gov/show/NCT00428948

Keywords

Versions (1)
  1. 8/28/18 8/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 28, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Polycystic Kidney Disease, Autosomal Dominant NCT00428948

English

Eligibility Polycystic Kidney Disease, Autosomal Dominant NCT00428948

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
gfr estimated at ≥60 ml/ min
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
diagnosis of adpkd and rapidly progressive kidney growth (total volume ≥750 cc) by magnetic resonance imaging (mri) at randomization
Description

Autosomal Dominant Polycystic Kidney Disease | Kidney Growth Rapidly progressive MRI | Kidney Total Volume MRI

Data type

boolean

Alias
UMLS CUI [1]
C0085413
UMLS CUI [2,1]
C0022646
UMLS CUI [2,2]
C0018270
UMLS CUI [2,3]
C1838681
UMLS CUI [2,4]
C0024485
UMLS CUI [3,1]
C0022646
UMLS CUI [3,2]
C0449468
UMLS CUI [3,3]
C0024485
legal adult age and able to give informed consent
Description

Legal Adult | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C1706450
UMLS CUI [2]
C0021430
willingness to comply with reproductive precautions if female
Description

Gender | Contraceptive methods Willing

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior exposure to tolvaptan or other experimental pkd therapies
Description

Exposure to Tolvaptan | Exposure to Experimental Therapies Polycystic Kidney Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1176308
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0949266
UMLS CUI [2,3]
C0022680
currently taking medication for purpose of affecting pkd cysts
Description

Pharmaceutical Preparations Affecting PKD Cysts

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0022680
UMLS CUI [1,4]
C0010709
women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods
Description

Breast Feeding | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
in the opinion of the study investigator or sponsor may present a safety risk or confound study objectives
Description

Safety Risk | Interference Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0036043
UMLS CUI [1,2]
C0035647
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C2348563
patients who are unlikely to adequately comply with study procedures
Description

Protocol Compliance Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
patients having contraindications to mri
Description

Medical contraindication MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
patients taking medications or having any illnesses likely to affect adpkd outcomes.
Description

Pharmaceutical Preparations Affecting Autosomal Dominant Polycystic Kidney Disease Outcome | Illness Affecting Autosomal Dominant Polycystic Kidney Disease Outcome

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0085413
UMLS CUI [1,4]
C1274040
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0085413
UMLS CUI [2,4]
C1274040
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Similar models

Eligibility Polycystic Kidney Disease, Autosomal Dominant NCT00428948

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Estimated Glomerular Filtration Rate
Item
gfr estimated at ≥60 ml/ min
boolean
C3811844 (UMLS CUI [1])
Autosomal Dominant Polycystic Kidney Disease | Kidney Growth Rapidly progressive MRI | Kidney Total Volume MRI
Item
diagnosis of adpkd and rapidly progressive kidney growth (total volume ≥750 cc) by magnetic resonance imaging (mri) at randomization
boolean
C0085413 (UMLS CUI [1])
C0022646 (UMLS CUI [2,1])
C0018270 (UMLS CUI [2,2])
C1838681 (UMLS CUI [2,3])
C0024485 (UMLS CUI [2,4])
C0022646 (UMLS CUI [3,1])
C0449468 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
Legal Adult | Informed Consent
Item
legal adult age and able to give informed consent
boolean
C1706450 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Gender | Contraceptive methods Willing
Item
willingness to comply with reproductive precautions if female
boolean
C0079399 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Exposure to Tolvaptan | Exposure to Experimental Therapies Polycystic Kidney Diseases
Item
prior exposure to tolvaptan or other experimental pkd therapies
boolean
C0332157 (UMLS CUI [1,1])
C1176308 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0949266 (UMLS CUI [2,2])
C0022680 (UMLS CUI [2,3])
Pharmaceutical Preparations Affecting PKD Cysts
Item
currently taking medication for purpose of affecting pkd cysts
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0022680 (UMLS CUI [1,3])
C0010709 (UMLS CUI [1,4])
Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods
boolean
C0006147 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Safety Risk | Interference Study Protocol
Item
in the opinion of the study investigator or sponsor may present a safety risk or confound study objectives
boolean
C0036043 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0521102 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Protocol Compliance Unlikely
Item
patients who are unlikely to adequately comply with study procedures
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
Medical contraindication MRI
Item
patients having contraindications to mri
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Pharmaceutical Preparations Affecting Autosomal Dominant Polycystic Kidney Disease Outcome | Illness Affecting Autosomal Dominant Polycystic Kidney Disease Outcome
Item
patients taking medications or having any illnesses likely to affect adpkd outcomes.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0085413 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
C0221423 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0085413 (UMLS CUI [2,3])
C1274040 (UMLS CUI [2,4])
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