ID

36815

Description

Safety and Efficacy Study of LHW090 in Resistant Hypertension Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02515331

Link

https://clinicaltrials.gov/show/NCT02515331

Keywords

Versions (1)
  1. 6/12/19 6/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Patients, Resistant Hypertension NCT02515331

English

Eligibility Patients, Resistant Hypertension NCT02515331

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female patients, age 40 to 85 years inclusive.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
• patients with uncontrolled hypertension (here defined as having a mean daytime bp ≥
Description

Uncontrolled hypertension | Mean blood pressure Daytime Ambulatory Blood Pressure Monitoring

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2,1]
C0428886
UMLS CUI [2,2]
C0332169
UMLS CUI [2,3]
C0242876
135/85 by abpm) despite treatment with a stable (at least 2 months) regimen that includes an optimal dose of an arb plus optimal doses of a diuretic plus one of the following classes of anti-hypertensive medications: beta-blockers or calcium channel blockers.
Description

Therapeutic procedure Stable | Angiotensin II receptor antagonist Dose Optimal | Diuretics Dose Optimal | Antihypertensive Agents Class Quantity | Adrenergic beta-1 Receptor Antagonists | Calcium Channel Blockers

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0521942
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C2698651
UMLS CUI [3,1]
C0012798
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C2698651
UMLS CUI [4,1]
C0003364
UMLS CUI [4,2]
C0456387
UMLS CUI [4,3]
C1265611
UMLS CUI [5]
C0304516
UMLS CUI [6]
C0006684
for the purposes of this trial, optimal doses of anti-hypertensive medications are defined as:
Description

Antihypertensive Agents Dose Optimal

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C2698651
the highest dose listed in the clinical practice guideline from the american society for hypertension and the international society for hypertension or
Description

Dose Highest Guideline recommendation

Data type

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1522410
UMLS CUI [1,3]
C0681471
the highest allowable prescribed dose per the manufacturer's label or
Description

Dose Highest Pharmaceutical Product Label

Data type

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1522410
UMLS CUI [1,3]
C1705425
the highest dose tolerated by an individual patient or
Description

Maximum Tolerated Dose Patient Specific

Data type

boolean

Alias
UMLS CUI [1,1]
C0752079
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0205369
the highest dose appropriate for an individual patient in the judgment of the investigator
Description

Dose Highest Appropriate Patient

Data type

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1522410
UMLS CUI [1,3]
C1548787
UMLS CUI [1,4]
C0030705
subjects must weigh at least 45 kg to participate in the study and must have a body mass index (bmi) within the range of 18-36 kg/m^2.
Description

Body Weight | Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with an estimated gfr <60 ml/min/1.73m^2.
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
use of angiotensin converting enzyme inhibitors (ace-inhibitors). note: patients who discontinue their ace-inhibitor and substitute with an angiotensin receptor blocker may be eligible to be re-screened provided their anti-hypertensive regimen has been stable for at least 2 months. any substitutions or changes to a patient's anti-hypertensive regimen should be done under the guidance of the patient's treating physician.
Description

Angiotensin-Converting Enzyme Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0003015
severe hypertension as defined by systolic blood pressure ≥180 mmhg or diastolic blood pressure ≥110 mmhg at screening.
Description

Hypertension, severe | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
a history of secondary hypertension of any etiology including but not limited to unilateral or bilateral renal artery stenosis, polycystic kidney disease, coarctation of the aorta, primary hyperaldosteronism, cushing's disease, pheochromocytoma, and drug-induced hypertension.
Description

Secondary hypertension Etiology Any | Unilateral renal artery stenosis | Bilateral renal artery stenosis | Polycystic Kidney Diseases | Aortic coarctation | Conn Syndrome | Cushing's disease | Pheochromocytoma | Hypertensive disease Drug-induced

Data type

boolean

Alias
UMLS CUI [1,1]
C0155616
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C1552551
UMLS CUI [2]
C0856759
UMLS CUI [3]
C0856760
UMLS CUI [4]
C0022680
UMLS CUI [5]
C0003492
UMLS CUI [6]
C1384514
UMLS CUI [7]
C0221406
UMLS CUI [8]
C0031511
UMLS CUI [9,1]
C0020538
UMLS CUI [9,2]
C0458082
known current significant left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or significant severe valvular disease on prior or current echocardiogram).
Description

Ventricular Outflow Obstruction, Left | Hypertrophic Cardiomyopathy | Valvular disease Severe Echocardiography

Data type

boolean

Alias
UMLS CUI [1]
C0023213
UMLS CUI [2]
C0007194
UMLS CUI [3,1]
C3258293
UMLS CUI [3,2]
C0205082
UMLS CUI [3,3]
C0013516
a history of known moderate or malignant retinopathy defined as moderate (retinal signs of hemorrhage), microaneurysms, cotton-wool spots, hard exudates, or a combination thereof) or malignant (signs of moderate retinopathy plus swelling of the optic disk).
Description

Retinal Disease Moderate | Retinal Disease Malignant Moderate | Retinal sign Hemorrhage | Microaneurysm | Cotton wool spots | Hard exudates | Signs Retinal Disease Moderate | Swelling Optic Disk

Data type

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0035309
UMLS CUI [2,2]
C0205282
UMLS CUI [2,3]
C0205081
UMLS CUI [3,1]
C0278230
UMLS CUI [3,2]
C0019080
UMLS CUI [4]
C0333101
UMLS CUI [5]
C0271053
UMLS CUI [6]
C0423410
UMLS CUI [7,1]
C0311392
UMLS CUI [7,2]
C0035309
UMLS CUI [7,3]
C0205081
UMLS CUI [8,1]
C0038999
UMLS CUI [8,2]
C0029127
to facilitate abpm assessment, an upper arm circumference greater than 42 cm.
Description

Upper arm Circumference

Data type

boolean

Alias
UMLS CUI [1,1]
C0446516
UMLS CUI [1,2]
C0332520
history within the previous 6 months of myocardial infarction, coronary artery bypass graft (cabg), percutaneous coronary intervention (pci), hypertensive encephalopathy, stroke, or transient ischemic attack (tia).
Description

Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3]
C1532338
UMLS CUI [4]
C0151620
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test.
Description

Pregnancy HCG pregnancy test Positive | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0546577
UMLS CUI [1,3]
C1514241
UMLS CUI [2]
C0006147
• women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless using highly effective contraception methods
Description

Childbearing Potential | Exception Use of Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0700589
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Similar models

Eligibility Patients, Resistant Hypertension NCT02515331

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male and female patients, age 40 to 85 years inclusive.
boolean
C0001779 (UMLS CUI [1])
Uncontrolled hypertension | Mean blood pressure Daytime Ambulatory Blood Pressure Monitoring
Item
• patients with uncontrolled hypertension (here defined as having a mean daytime bp ≥
boolean
C1868885 (UMLS CUI [1])
C0428886 (UMLS CUI [2,1])
C0332169 (UMLS CUI [2,2])
C0242876 (UMLS CUI [2,3])
Therapeutic procedure Stable | Angiotensin II receptor antagonist Dose Optimal | Diuretics Dose Optimal | Antihypertensive Agents Class Quantity | Adrenergic beta-1 Receptor Antagonists | Calcium Channel Blockers
Item
135/85 by abpm) despite treatment with a stable (at least 2 months) regimen that includes an optimal dose of an arb plus optimal doses of a diuretic plus one of the following classes of anti-hypertensive medications: beta-blockers or calcium channel blockers.
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0521942 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C2698651 (UMLS CUI [2,3])
C0012798 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C2698651 (UMLS CUI [3,3])
C0003364 (UMLS CUI [4,1])
C0456387 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0304516 (UMLS CUI [5])
C0006684 (UMLS CUI [6])
Antihypertensive Agents Dose Optimal
Item
for the purposes of this trial, optimal doses of anti-hypertensive medications are defined as:
boolean
C0003364 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2698651 (UMLS CUI [1,3])
Dose Highest Guideline recommendation
Item
the highest dose listed in the clinical practice guideline from the american society for hypertension and the international society for hypertension or
boolean
C0178602 (UMLS CUI [1,1])
C1522410 (UMLS CUI [1,2])
C0681471 (UMLS CUI [1,3])
Dose Highest Pharmaceutical Product Label
Item
the highest allowable prescribed dose per the manufacturer's label or
boolean
C0178602 (UMLS CUI [1,1])
C1522410 (UMLS CUI [1,2])
C1705425 (UMLS CUI [1,3])
Maximum Tolerated Dose Patient Specific
Item
the highest dose tolerated by an individual patient or
boolean
C0752079 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Dose Highest Appropriate Patient
Item
the highest dose appropriate for an individual patient in the judgment of the investigator
boolean
C0178602 (UMLS CUI [1,1])
C1522410 (UMLS CUI [1,2])
C1548787 (UMLS CUI [1,3])
C0030705 (UMLS CUI [1,4])
Body Weight | Body mass index
Item
subjects must weigh at least 45 kg to participate in the study and must have a body mass index (bmi) within the range of 18-36 kg/m^2.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Estimated Glomerular Filtration Rate
Item
patients with an estimated gfr <60 ml/min/1.73m^2.
boolean
C3811844 (UMLS CUI [1])
Angiotensin-Converting Enzyme Inhibitors
Item
use of angiotensin converting enzyme inhibitors (ace-inhibitors). note: patients who discontinue their ace-inhibitor and substitute with an angiotensin receptor blocker may be eligible to be re-screened provided their anti-hypertensive regimen has been stable for at least 2 months. any substitutions or changes to a patient's anti-hypertensive regimen should be done under the guidance of the patient's treating physician.
boolean
C0003015 (UMLS CUI [1])
Hypertension, severe | Systolic Pressure | Diastolic blood pressure
Item
severe hypertension as defined by systolic blood pressure ≥180 mmhg or diastolic blood pressure ≥110 mmhg at screening.
boolean
C4013784 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Secondary hypertension Etiology Any | Unilateral renal artery stenosis | Bilateral renal artery stenosis | Polycystic Kidney Diseases | Aortic coarctation | Conn Syndrome | Cushing's disease | Pheochromocytoma | Hypertensive disease Drug-induced
Item
a history of secondary hypertension of any etiology including but not limited to unilateral or bilateral renal artery stenosis, polycystic kidney disease, coarctation of the aorta, primary hyperaldosteronism, cushing's disease, pheochromocytoma, and drug-induced hypertension.
boolean
C0155616 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0856759 (UMLS CUI [2])
C0856760 (UMLS CUI [3])
C0022680 (UMLS CUI [4])
C0003492 (UMLS CUI [5])
C1384514 (UMLS CUI [6])
C0221406 (UMLS CUI [7])
C0031511 (UMLS CUI [8])
C0020538 (UMLS CUI [9,1])
C0458082 (UMLS CUI [9,2])
Ventricular Outflow Obstruction, Left | Hypertrophic Cardiomyopathy | Valvular disease Severe Echocardiography
Item
known current significant left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or significant severe valvular disease on prior or current echocardiogram).
boolean
C0023213 (UMLS CUI [1])
C0007194 (UMLS CUI [2])
C3258293 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0013516 (UMLS CUI [3,3])
Retinal Disease Moderate | Retinal Disease Malignant Moderate | Retinal sign Hemorrhage | Microaneurysm | Cotton wool spots | Hard exudates | Signs Retinal Disease Moderate | Swelling Optic Disk
Item
a history of known moderate or malignant retinopathy defined as moderate (retinal signs of hemorrhage), microaneurysms, cotton-wool spots, hard exudates, or a combination thereof) or malignant (signs of moderate retinopathy plus swelling of the optic disk).
boolean
C0035309 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0035309 (UMLS CUI [2,1])
C0205282 (UMLS CUI [2,2])
C0205081 (UMLS CUI [2,3])
C0278230 (UMLS CUI [3,1])
C0019080 (UMLS CUI [3,2])
C0333101 (UMLS CUI [4])
C0271053 (UMLS CUI [5])
C0423410 (UMLS CUI [6])
C0311392 (UMLS CUI [7,1])
C0035309 (UMLS CUI [7,2])
C0205081 (UMLS CUI [7,3])
C0038999 (UMLS CUI [8,1])
C0029127 (UMLS CUI [8,2])
Upper arm Circumference
Item
to facilitate abpm assessment, an upper arm circumference greater than 42 cm.
boolean
C0446516 (UMLS CUI [1,1])
C0332520 (UMLS CUI [1,2])
Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack
Item
history within the previous 6 months of myocardial infarction, coronary artery bypass graft (cabg), percutaneous coronary intervention (pci), hypertensive encephalopathy, stroke, or transient ischemic attack (tia).
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
C0151620 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
Pregnancy HCG pregnancy test Positive | Breast Feeding
Item
pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test.
boolean
C0032961 (UMLS CUI [1,1])
C0546577 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0006147 (UMLS CUI [2])
Childbearing Potential | Exception Use of Contraceptive methods
Item
• women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless using highly effective contraception methods
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
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