ID

39983

Description

MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352); ODM derived from: https://clinicaltrials.gov/show/NCT01307046

Link

https://clinicaltrials.gov/show/NCT01307046

Keywords

Versions (1)
  1. 3/8/20 3/8/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 8, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01307046

English

Eligibility Hypertension NCT01307046

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant has a diagnosis of essential hypertension.
Description

Essential Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0085580
participant is not treated with antihypertensive medication and meets protocol-specified blood pressure criteria.
Description

Antihypertensive Agents Absent | Blood Pressure Criteria Study Protocol | Blood Pressure Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0005823
UMLS CUI [2,2]
C0243161
UMLS CUI [2,3]
C2348563
UMLS CUI [3,1]
C0005823
UMLS CUI [3,2]
C0243161
UMLS CUI [3,3]
C1550543
participant is treated with single antihypertensive medication, and meets protocol-specified blood pressure criteria.
Description

Antihypertensive Agent Single | Blood Pressure Criteria Study Protocol | Blood Pressure Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0205171
UMLS CUI [2,1]
C0005823
UMLS CUI [2,2]
C0243161
UMLS CUI [2,3]
C2348563
UMLS CUI [3,1]
C0005823
UMLS CUI [3,2]
C0243161
UMLS CUI [3,3]
C1550543
participant is being treated with up to dual oral antihypertensive medications, and will be able to discontinue the prior antihypertensive medication.
Description

Antihypertensive Agents Quantity | Ability Discontinue Antihypertensive Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0003364
participant has no clinically meaningful findings to be disqualified from the study at the discretion of the investigator.
Description

Ineligibility Findings Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C0037088
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
regarding hypertension, participant is currently taking > 2 antihypertensive medications.
Description

Antihypertensive Agents Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
participant has a history of significant multiple and/or severe allergies to ingredients of nu-lotan or preminent and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines)
Description

Multiple allergies Ingredient Losartan Potassium | Severe allergy Ingredient Losartan Potassium | Multiple allergies Ingredient Preminent | Severe allergy Ingredient Preminent | Multiple allergies Ingredient Thiazide | Severe allergy Ingredient Thiazide | Multiple allergies Ingredient Chlorthalidone | Severe allergy Ingredient Chlorthalidone

Data type

boolean

Alias
UMLS CUI [1,1]
C0740281
UMLS CUI [1,2]
C1550600
UMLS CUI [1,3]
C0700492
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C1550600
UMLS CUI [2,3]
C0700492
UMLS CUI [3,1]
C0740281
UMLS CUI [3,2]
C1550600
UMLS CUI [3,3]
C0138304
UMLS CUI [4,1]
C2945656
UMLS CUI [4,2]
C1550600
UMLS CUI [4,3]
C0138304
UMLS CUI [5,1]
C0740281
UMLS CUI [5,2]
C1550600
UMLS CUI [5,3]
C0541746
UMLS CUI [6,1]
C2945656
UMLS CUI [6,2]
C1550600
UMLS CUI [6,3]
C0541746
UMLS CUI [7,1]
C0740281
UMLS CUI [7,2]
C1550600
UMLS CUI [7,3]
C0008294
UMLS CUI [8,1]
C2945656
UMLS CUI [8,2]
C1550600
UMLS CUI [8,3]
C0008294
participant is, at the time of signing informed consent, a user of recreational or illicit drugs or a recent history within the last year of drug or alcohol abuse or dependence.
Description

Recreational drug use | Illicit medication use | Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0281875
UMLS CUI [3]
C0038586
participant is pregnant or breastfeeding or expecting to conceive or has a positive pregnancy test at the screening visit.
Description

Pregnancy | Breast Feeding | Pregnancy, Planned | Pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4]
C0240802
participant is currently participating or has participated in a study with an investigational compound (except losartan at any doses) or device within 30 days of signing informed consent.
Description

Study Subject Participation Status | Investigational New Drugs | Exception Losartan Dose Any | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0126174
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C1552551
UMLS CUI [4]
C2346570
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Similar models

Eligibility Hypertension NCT01307046

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension
Item
participant has a diagnosis of essential hypertension.
boolean
C0085580 (UMLS CUI [1])
Antihypertensive Agents Absent | Blood Pressure Criteria Study Protocol | Blood Pressure Criteria Fulfill
Item
participant is not treated with antihypertensive medication and meets protocol-specified blood pressure criteria.
boolean
C0003364 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0005823 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
C0005823 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
C1550543 (UMLS CUI [3,3])
Antihypertensive Agent Single | Blood Pressure Criteria Study Protocol | Blood Pressure Criteria Fulfill
Item
participant is treated with single antihypertensive medication, and meets protocol-specified blood pressure criteria.
boolean
C0003364 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0005823 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
C0005823 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
C1550543 (UMLS CUI [3,3])
Antihypertensive Agents Quantity | Ability Discontinue Antihypertensive Agents
Item
participant is being treated with up to dual oral antihypertensive medications, and will be able to discontinue the prior antihypertensive medication.
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0003364 (UMLS CUI [2,3])
Ineligibility Findings Absent
Item
participant has no clinically meaningful findings to be disqualified from the study at the discretion of the investigator.
boolean
C1512714 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Antihypertensive Agents Quantity
Item
regarding hypertension, participant is currently taking > 2 antihypertensive medications.
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Multiple allergies Ingredient Losartan Potassium | Severe allergy Ingredient Losartan Potassium | Multiple allergies Ingredient Preminent | Severe allergy Ingredient Preminent | Multiple allergies Ingredient Thiazide | Severe allergy Ingredient Thiazide | Multiple allergies Ingredient Chlorthalidone | Severe allergy Ingredient Chlorthalidone
Item
participant has a history of significant multiple and/or severe allergies to ingredients of nu-lotan or preminent and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines)
boolean
C0740281 (UMLS CUI [1,1])
C1550600 (UMLS CUI [1,2])
C0700492 (UMLS CUI [1,3])
C2945656 (UMLS CUI [2,1])
C1550600 (UMLS CUI [2,2])
C0700492 (UMLS CUI [2,3])
C0740281 (UMLS CUI [3,1])
C1550600 (UMLS CUI [3,2])
C0138304 (UMLS CUI [3,3])
C2945656 (UMLS CUI [4,1])
C1550600 (UMLS CUI [4,2])
C0138304 (UMLS CUI [4,3])
C0740281 (UMLS CUI [5,1])
C1550600 (UMLS CUI [5,2])
C0541746 (UMLS CUI [5,3])
C2945656 (UMLS CUI [6,1])
C1550600 (UMLS CUI [6,2])
C0541746 (UMLS CUI [6,3])
C0740281 (UMLS CUI [7,1])
C1550600 (UMLS CUI [7,2])
C0008294 (UMLS CUI [7,3])
C2945656 (UMLS CUI [8,1])
C1550600 (UMLS CUI [8,2])
C0008294 (UMLS CUI [8,3])
Recreational drug use | Illicit medication use | Substance Use Disorders
Item
participant is, at the time of signing informed consent, a user of recreational or illicit drugs or a recent history within the last year of drug or alcohol abuse or dependence.
boolean
C0013146 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Pregnancy test positive
Item
participant is pregnant or breastfeeding or expecting to conceive or has a positive pregnancy test at the screening visit.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0240802 (UMLS CUI [4])
Study Subject Participation Status | Investigational New Drugs | Exception Losartan Dose Any | Investigational Medical Device
Item
participant is currently participating or has participated in a study with an investigational compound (except losartan at any doses) or device within 30 days of signing informed consent.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0126174 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C1552551 (UMLS CUI [3,4])
C2346570 (UMLS CUI [4])
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