ID

40319

Description

Add-on to Micamlo BP Trial; ODM derived from: https://clinicaltrials.gov/show/NCT01975246

Link

https://clinicaltrials.gov/show/NCT01975246

Keywords

Versions (1)
  1. 4/7/20 4/7/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 7, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01975246

English

Eligibility Hypertension NCT01975246

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
essential hypertensive patients who have already taking 2 or 3 antihypertensive drugs and mean seated diastolic blood pressure (dbp) must be >=90 and <=114 mmhg and mean seated systolic blood pressure (sbp) must be =<200 mmhg
Description

Essential Hypertension | Antihypertensive Agents Quantity | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
UMLS CUI [4,1]
C1319893
UMLS CUI [4,2]
C0444504
able to stop all current antihypertensive drugs (other than study medication) from visit 1b through the end of the trial without risk to the patient based on the investigator's opinion
Description

Ability Discontinue Antihypertensive Agents | Exception Investigational New Drugs | Patient Risk Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0003364
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0035647
UMLS CUI [3,3]
C0332197
age 20 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with known or suspected secondary hypertension
Description

Secondary hypertension | Secondary hypertension Suspected

Data type

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0155616
UMLS CUI [2,2]
C0750491
patients with clinically relevant cardiac arrhythmia
Description

Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0003811
congestive heart failure with new york heart association (nyha) functional class iii-iv
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
patients with recent cardiovascular events
Description

Cardiovascular event Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0332185
patients with recent stroke events
Description

Cerebrovascular accident Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0332185
patients with a history of sudden deterioration of renal function with angiotensin ii receptor blockers or angiotensin converting enzyme inhibitors; or patients with post-renal transplant or post-nephrectomy
Description

Renal function Deterioration Sudden | Angiotensin II receptor antagonist | Angiotensin-Converting Enzyme Inhibitors | Status post Kidney Transplantation | Status post Nephrectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0868945
UMLS CUI [1,3]
C1272517
UMLS CUI [2]
C0521942
UMLS CUI [3]
C0003015
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0022671
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0027695
patients with hepatic and/or renal dysfunction
Description

Liver Dysfunction | Renal dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C3279454
pre-menopausal women who are nursing or pregnant
Description

Breast Feeding | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
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Similar models

Eligibility Hypertension NCT01975246

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension | Antihypertensive Agents Quantity | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
essential hypertensive patients who have already taking 2 or 3 antihypertensive drugs and mean seated diastolic blood pressure (dbp) must be >=90 and <=114 mmhg and mean seated systolic blood pressure (sbp) must be =<200 mmhg
boolean
C0085580 (UMLS CUI [1])
C0003364 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C1319893 (UMLS CUI [4,1])
C0444504 (UMLS CUI [4,2])
Ability Discontinue Antihypertensive Agents | Exception Investigational New Drugs | Patient Risk Absent
Item
able to stop all current antihypertensive drugs (other than study medication) from visit 1b through the end of the trial without risk to the patient based on the investigator's opinion
boolean
C0085732 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0003364 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0030705 (UMLS CUI [3,1])
C0035647 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Age
Item
age 20 years or older
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension | Secondary hypertension Suspected
Item
patients with known or suspected secondary hypertension
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Cardiac Arrhythmia
Item
patients with clinically relevant cardiac arrhythmia
boolean
C0003811 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
congestive heart failure with new york heart association (nyha) functional class iii-iv
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Cardiovascular event Recent
Item
patients with recent cardiovascular events
boolean
C1320716 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Cerebrovascular accident Recent
Item
patients with recent stroke events
boolean
C0038454 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Renal function Deterioration Sudden | Angiotensin II receptor antagonist | Angiotensin-Converting Enzyme Inhibitors | Status post Kidney Transplantation | Status post Nephrectomy
Item
patients with a history of sudden deterioration of renal function with angiotensin ii receptor blockers or angiotensin converting enzyme inhibitors; or patients with post-renal transplant or post-nephrectomy
boolean
C0232804 (UMLS CUI [1,1])
C0868945 (UMLS CUI [1,2])
C1272517 (UMLS CUI [1,3])
C0521942 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0231290 (UMLS CUI [4,1])
C0022671 (UMLS CUI [4,2])
C0231290 (UMLS CUI [5,1])
C0027695 (UMLS CUI [5,2])
Liver Dysfunction | Renal dysfunction
Item
patients with hepatic and/or renal dysfunction
boolean
C0086565 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
Breast Feeding | Pregnancy
Item
pre-menopausal women who are nursing or pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
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