ID

29904

Description

Pharmacokinetic Drug Interaction Study Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00548067

Link

https://clinicaltrials.gov/show/NCT00548067

Keywords

Versions (1)
  1. 4/26/18 4/26/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 26, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00548067

English

Eligibility Hypertension NCT00548067

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients diagnosed as hypertensive
Description

Hypertensive disease

Data type

boolean

Alias
UMLS CUI [1]
C0020538
untreated confirmed hypertensive patients (consistent sbp >140 mm hg or dbp >90 mm hg)
Description

Hypertensive disease untreated | Systolic Pressure Consistent | Diastolic blood pressure Consistent

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0332290
UMLS CUI [3,1]
C0428883
UMLS CUI [3,2]
C0332290
uncontrolled hypertensive patients (consistent sbp >140 mm hg or dbp >90 mm hg) on one drug therapy.
Description

Hypertensive disease Uncontrolled | Systolic Pressure Consistent | Diastolic blood pressure Consistent | Pharmacotherapy Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0332290
UMLS CUI [3,1]
C0428883
UMLS CUI [3,2]
C0332290
UMLS CUI [4,1]
C0013216
UMLS CUI [4,2]
C1265611
uncontrolled hypertensive patients (consistent sbp >140 mm hg or dbp >90 mm hg) on two drug therapy.
Description

Hypertensive disease Uncontrolled | Systolic Pressure Consistent | Diastolic blood pressure Consistent | Pharmacotherapy Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0332290
UMLS CUI [3,1]
C0428883
UMLS CUI [3,2]
C0332290
UMLS CUI [4,1]
C0013216
UMLS CUI [4,2]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to switch from all prior antihypertensive medications safely as required by the protocol.
Description

Antihypertensive Agents | Change of medication Unable

Data type

boolean

Alias
UMLS CUI [1]
C0003364
UMLS CUI [2,1]
C0580105
UMLS CUI [2,2]
C1299582
need for drugs other than study drugs at the time of baseline.
Description

Patient need for Pharmaceutical Preparations | Exception Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0013227
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013230
patients with sbp ≥ 180 mmhg and/or dbp ≥ 110 mmhg at screening.
Description

Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
patients on four or more antihypertensive drugs at screening.
Description

Antihypertensive Agents Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
pregnant or nursing (lactating) women.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with diabetes mellitus
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
patients with heart diseases and any other disease
Description

Heart Diseases | Disease Other Any

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C1552551
other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Hypertension NCT00548067

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hypertensive disease
Item
patients diagnosed as hypertensive
boolean
C0020538 (UMLS CUI [1])
Hypertensive disease untreated | Systolic Pressure Consistent | Diastolic blood pressure Consistent
Item
untreated confirmed hypertensive patients (consistent sbp >140 mm hg or dbp >90 mm hg)
boolean
C0020538 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0428883 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
Hypertensive disease Uncontrolled | Systolic Pressure Consistent | Diastolic blood pressure Consistent | Pharmacotherapy Quantity
Item
uncontrolled hypertensive patients (consistent sbp >140 mm hg or dbp >90 mm hg) on one drug therapy.
boolean
C0020538 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0428883 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0013216 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Hypertensive disease Uncontrolled | Systolic Pressure Consistent | Diastolic blood pressure Consistent | Pharmacotherapy Quantity
Item
uncontrolled hypertensive patients (consistent sbp >140 mm hg or dbp >90 mm hg) on two drug therapy.
boolean
C0020538 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2,1])
C0332290 (UMLS CUI [2,2])
C0428883 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
C0013216 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Antihypertensive Agents | Change of medication Unable
Item
inability to switch from all prior antihypertensive medications safely as required by the protocol.
boolean
C0003364 (UMLS CUI [1])
C0580105 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Patient need for Pharmaceutical Preparations | Exception Investigational New Drugs
Item
need for drugs other than study drugs at the time of baseline.
boolean
C0686904 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Systolic Pressure | Diastolic blood pressure
Item
patients with sbp ≥ 180 mmhg and/or dbp ≥ 110 mmhg at screening.
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Antihypertensive Agents Quantity
Item
patients on four or more antihypertensive drugs at screening.
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing (lactating) women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Diabetes Mellitus
Item
patients with diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Heart Diseases | Disease Other Any
Item
patients with heart diseases and any other disease
boolean
C0018799 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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