ID

31655

Description

Open-Label Tolvaptan Study in Subjects With ADPKD; ODM derived from: https://clinicaltrials.gov/show/NCT01214421 Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Information provided by (Responsible Party): Otsuka Pharmaceutical Development & Commercialization, Inc. Study Director: Frank Czerwiec, MD, PhD Otsuka Pharmaceutical Development & Commercialization, Inc.

Link

https://clinicaltrials.gov/show/NCT01214421

Keywords

Versions (1)
  1. 9/17/18 9/17/18 -
Copyright Holder

Otsuka Pharmaceutical Development & Commercialization, Inc.

Uploaded on

September 17, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT01214421

English

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT01214421

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who have successfully completed a phase 1, 2, or 3 tolvaptan adpkd or renal impairment trial, with a confirmed diagnosis of adpkd
Description

Successful completion of phase 1,2 or 3 tolvaptan adpkd or renal impairment trial, with a confirmed diagnosis of adpkd

Data type

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0085413
UMLS CUI [2,1]
C0805732
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1176308
UMLS CUI [3,1]
C0805732
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1565489
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects unable to provide written informed consent
Description

Absence of informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332197
subjects (men or women) who will not adhere to the reproductive precautions as outlined in the informed consent form
Description

Lack of proper contraception

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0332197
subjects (women only) with a positive urine pregnancy test
Description

Women with a positive pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0240802
subjects who are pregnant or breast-feeding
Description

Pregnancy or breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects unable to take oral medications
Description

Inability to take oral medications

Data type

boolean

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C1299582
subjects who have allergic reactions to tolvaptan or chemically related structures such as benzazepines (benzazepril, conivaptan, fenoldopam mesylate or mirtazapine)
Description

Hypersensitivity to tolvaptan or chemically related structures such as benzazepines

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1176308
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0220807
UMLS CUI [2,3]
C2348205
UMLS CUI [2,4]
C1176308
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0005034
subjects who have disorders in thirst recognition or an inability to access fluids
Description

Disorders in thirst recognition or inability to access fluids

Data type

boolean

Alias
UMLS CUI [1,1]
C0599535
UMLS CUI [1,2]
C0012634
UMLS CUI [2,1]
C1299582
UMLS CUI [2,2]
C2013463
subjects with critical electrolyte imbalances, as determined by the investigator
Description

Critical electrolyte imbalances

Data type

boolean

Alias
UMLS CUI [1,1]
C0342579
UMLS CUI [1,2]
C1511545
subjects with or at risk of significant hypovolemia, as determined by investigator
Description

Having or being at risk of significant hypovolemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0205420
UMLS CUI [1,2]
C0546884
UMLS CUI [2,1]
C0332190
UMLS CUI [2,2]
C0546884
subjects with anemia, as determined by investigator
Description

Anemia

Data type

boolean

Alias
UMLS CUI [1]
C0002871
subjects with a history of substance abuse (within the last 3 years)
Description

History of substance abuse

Data type

boolean

Alias
UMLS CUI [1]
C1299544
subjects taking other experimental (ie, non-marketed) therapies or current participation in another clinical drug or device trial; current participation in the off-drug follow-up period of another adpkd trial with tolvaptan is permitted
Description

Other experimental therapies or current participation in another clinical drug or device trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
Efficacy Analysis Exclusion Criteria
Description

Efficacy Analysis Exclusion Criteria

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0235828
subjects unable to complete mri assessments (eg, subjects with ferro-magnetic prostheses, aneurysm clips, severe claustrophobia)
Description

Inability to complete mri assessments, e.g. due to ferro-magnetic prostheses, aneurysm clips, severe claustrophobia

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0008909
UMLS CUI [3,1]
C0175649
UMLS CUI [3,2]
C2986473
UMLS CUI [4]
C0179977
subjects who have taken a vasopressin antagonist (outside of previous participation in a tolvaptan trial)
Description

Former treatment with a vasopressin antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C3537128
UMLS CUI [1,3]
C0332300
UMLS CUI [1,4]
C1176308
subjects unable to comply with anti-hypertensive or other important medical therapy
Description

Incompliance with important medical therapy such as anti-hypertensive therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0457432
UMLS CUI [1,2]
C3898777
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0457432
UMLS CUI [2,2]
C0585941
subjects with advanced diabetes
Description

Advanced diabetes

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0205179
subjects taking medications or having an illness that could confound endpoint assessments (including taking approved therapies for the purpose of affecting pkd cysts)
Description

Confounding medication or comorbiditiy (including taking approved therapies for the purpose of affecting pkd cysts)

Data type

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2603343
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2603343
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Similar models

Eligibility Autosomal Dominant Polycystic Kidney Disease (ADPKD) NCT01214421

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Successful completion of phase 1,2 or 3 tolvaptan adpkd or renal impairment trial, with a confirmed diagnosis of adpkd
Item
subjects who have successfully completed a phase 1, 2, or 3 tolvaptan adpkd or renal impairment trial, with a confirmed diagnosis of adpkd
boolean
C0750484 (UMLS CUI [1,1])
C0085413 (UMLS CUI [1,2])
C0805732 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1176308 (UMLS CUI [2,3])
C0805732 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1565489 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Absence of informed consent
Item
subjects unable to provide written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Lack of proper contraception
Item
subjects (men or women) who will not adhere to the reproductive precautions as outlined in the informed consent form
boolean
C0700589 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Women with a positive pregnancy test
Item
subjects (women only) with a positive urine pregnancy test
boolean
C0240802 (UMLS CUI [1])
Pregnancy or breast feeding
Item
subjects who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Inability to take oral medications
Item
subjects unable to take oral medications
boolean
C0175795 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Hypersensitivity to tolvaptan or chemically related structures such as benzazepines
Item
subjects who have allergic reactions to tolvaptan or chemically related structures such as benzazepines (benzazepril, conivaptan, fenoldopam mesylate or mirtazapine)
boolean
C0020517 (UMLS CUI [1,1])
C1176308 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0220807 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
C1176308 (UMLS CUI [2,4])
C0020517 (UMLS CUI [3,1])
C0005034 (UMLS CUI [3,2])
Disorders in thirst recognition or inability to access fluids
Item
subjects who have disorders in thirst recognition or an inability to access fluids
boolean
C0599535 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1299582 (UMLS CUI [2,1])
C2013463 (UMLS CUI [2,2])
Critical electrolyte imbalances
Item
subjects with critical electrolyte imbalances, as determined by the investigator
boolean
C0342579 (UMLS CUI [1,1])
C1511545 (UMLS CUI [1,2])
Having or being at risk of significant hypovolemia
Item
subjects with or at risk of significant hypovolemia, as determined by investigator
boolean
C0205420 (UMLS CUI [1,1])
C0546884 (UMLS CUI [1,2])
C0332190 (UMLS CUI [2,1])
C0546884 (UMLS CUI [2,2])
Anemia
Item
subjects with anemia, as determined by investigator
boolean
C0002871 (UMLS CUI [1])
History of substance abuse
Item
subjects with a history of substance abuse (within the last 3 years)
boolean
C1299544 (UMLS CUI [1])
Other experimental therapies or current participation in another clinical drug or device trial
Item
subjects taking other experimental (ie, non-marketed) therapies or current participation in another clinical drug or device trial; current participation in the off-drug follow-up period of another adpkd trial with tolvaptan is permitted
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI-1)
C0235828 (UMLS CUI-2)
Inability to complete mri assessments, e.g. due to ferro-magnetic prostheses, aneurysm clips, severe claustrophobia
Item
subjects unable to complete mri assessments (eg, subjects with ferro-magnetic prostheses, aneurysm clips, severe claustrophobia)
boolean
C1299582 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0008909 (UMLS CUI [2])
C0175649 (UMLS CUI [3,1])
C2986473 (UMLS CUI [3,2])
C0179977 (UMLS CUI [4])
Former treatment with a vasopressin antagonist
Item
subjects who have taken a vasopressin antagonist (outside of previous participation in a tolvaptan trial)
boolean
C1514463 (UMLS CUI [1,1])
C3537128 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C1176308 (UMLS CUI [1,4])
Incompliance with important medical therapy such as anti-hypertensive therapy
Item
subjects unable to comply with anti-hypertensive or other important medical therapy
boolean
C0457432 (UMLS CUI [1,1])
C3898777 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0457432 (UMLS CUI [2,1])
C0585941 (UMLS CUI [2,2])
Advanced diabetes
Item
subjects with advanced diabetes
boolean
C0011849 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Confounding medication or comorbiditiy (including taking approved therapies for the purpose of affecting pkd cysts)
Item
subjects taking medications or having an illness that could confound endpoint assessments (including taking approved therapies for the purpose of affecting pkd cysts)
boolean
C2347852 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2603343 (UMLS CUI [2,3])
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