ID

44240

Description

Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00853957

Link

https://clinicaltrials.gov/show/NCT00853957

Keywords

Versions (2)
  1. 5/2/18 5/2/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00853957

English

Eligibility Hypertension NCT00853957

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women of african american background; self identified
Description

African American

Data type

boolean

Alias
UMLS CUI [1]
C0085756
patients with stage 2 hypertension defined as mssbp ≥ 160 mmhg and < 200 mmhg at visit 5 (randomization
Description

Hypertensive disease Stage | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0699749
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
office blood pressure measured by cuff (msdbp ≥ 110 mmhg and/or mssbp ≥ 200 mmhg)
Description

Blood pressure measurement | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1]
C0005824
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
patients on 4 or more antihypertensive medications.
Description

Antihypertensive Agents Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
patients with uncontrolled hypertension (mssbp >180 mmhg) taking more than 1 antihypertensive medication at visit 1
Description

Uncontrolled hypertension | Sitting systolic blood pressure mean | Antihypertensive Agents Quantity

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C1265611
refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmhg). therapy with a fixed dose combination of two active substances represent two drugs.
Description

Refractory hypertension | Pharmacotherapy Triple Unresponsive to Treatment | Pharmaceutical Preparations Maximum Tolerated Dose | Diuretics | Blood Pressure Goal failed | Combined Modality Therapy | Pharmaceutical Preparations Quantity Dose Stable

Data type

boolean

Alias
UMLS CUI [1]
C0860493
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0205174
UMLS CUI [2,3]
C0205269
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0752079
UMLS CUI [4]
C0012798
UMLS CUI [5,1]
C0005823
UMLS CUI [5,2]
C0679840
UMLS CUI [5,3]
C0231175
UMLS CUI [6]
C0009429
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C1265611
UMLS CUI [7,3]
C0178602
UMLS CUI [7,4]
C0205360
history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Description

Malignant Neoplasms Organ system Treated | Malignant Neoplasms Organ system Untreated | Exception Basal cell carcinoma Localized | Malignant Neoplasms Independent of Recurrent disease Local | Malignant Neoplasms Independent of Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0460002
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0460002
UMLS CUI [2,3]
C0332155
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C0392752
UMLS CUI [4,1]
C0006826
UMLS CUI [4,2]
C0332291
UMLS CUI [4,3]
C0277556
UMLS CUI [4,4]
C0205276
UMLS CUI [5,1]
C0006826
UMLS CUI [5,2]
C0332291
UMLS CUI [5,3]
C0027627
evidence of a secondary form of hypertension, including but not limited to any of the following:
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
coarctation of the aorta
Description

Aortic coarctation

Data type

boolean

Alias
UMLS CUI [1]
C0003492
hyperaldosteronism
Description

Hyperaldosteronism

Data type

boolean

Alias
UMLS CUI [1]
C0020428
unilateral or bilateral renal artery stenosis
Description

Unilateral renal artery stenosis | Bilateral renal artery stenosis

Data type

boolean

Alias
UMLS CUI [1]
C0856759
UMLS CUI [2]
C0856760
cushing's disease
Description

Cushing's disease

Data type

boolean

Alias
UMLS CUI [1]
C0221406
polycystic kidney disease
Description

Polycystic Kidney Disease

Data type

boolean

Alias
UMLS CUI [1]
C0022680
pheochromocytoma
Description

Pheochromocytoma

Data type

boolean

Alias
UMLS CUI [1]
C0031511
known keith-wagener grade iii or iv hypertensive retinopathy.
Description

Hypertensive Retinopathy Grade

Data type

boolean

Alias
UMLS CUI [1,1]
C0152132
UMLS CUI [1,2]
C0441800
history of angioedema due to usage of an arb or ace inhibitor.
Description

Angioedema Due to Angiotensin II receptor antagonist | Angioedema due to angiotensin-converting-enzyme inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0002994
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0521942
UMLS CUI [2]
C1304495
history of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, heart failure (nyha class ii-iv), coronary bypass graft surgery (cabg), percutaneous coronary intervention (pci), unstable angina pectoris, or myocardial infarction in the last 12 months
Description

Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Heart failure New York Heart Association Classification | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Angina, Unstable | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0151620
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C1275491
UMLS CUI [5]
C0010055
UMLS CUI [6]
C1532338
UMLS CUI [7]
C0002965
UMLS CUI [8]
C0027051
other protocol defined inclusion/exclusion criteria applied
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 NCT00853957

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
African American
Item
men or women of african american background; self identified
boolean
C0085756 (UMLS CUI [1])
Hypertensive disease Stage | Sitting systolic blood pressure mean
Item
patients with stage 2 hypertension defined as mssbp ≥ 160 mmhg and < 200 mmhg at visit 5 (randomization
boolean
C0020538 (UMLS CUI [1,1])
C0699749 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Blood pressure measurement | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
office blood pressure measured by cuff (msdbp ≥ 110 mmhg and/or mssbp ≥ 200 mmhg)
boolean
C0005824 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Antihypertensive Agents Quantity
Item
patients on 4 or more antihypertensive medications.
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Uncontrolled hypertension | Sitting systolic blood pressure mean | Antihypertensive Agents Quantity
Item
patients with uncontrolled hypertension (mssbp >180 mmhg) taking more than 1 antihypertensive medication at visit 1
boolean
C1868885 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0003364 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Refractory hypertension | Pharmacotherapy Triple Unresponsive to Treatment | Pharmaceutical Preparations Maximum Tolerated Dose | Diuretics | Blood Pressure Goal failed | Combined Modality Therapy | Pharmaceutical Preparations Quantity Dose Stable
Item
refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmhg). therapy with a fixed dose combination of two active substances represent two drugs.
boolean
C0860493 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C0205174 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0012798 (UMLS CUI [4])
C0005823 (UMLS CUI [5,1])
C0679840 (UMLS CUI [5,2])
C0231175 (UMLS CUI [5,3])
C0009429 (UMLS CUI [6])
C0013227 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0178602 (UMLS CUI [7,3])
C0205360 (UMLS CUI [7,4])
Malignant Neoplasms Organ system Treated | Malignant Neoplasms Organ system Untreated | Exception Basal cell carcinoma Localized | Malignant Neoplasms Independent of Recurrent disease Local | Malignant Neoplasms Independent of Neoplasm Metastasis
Item
history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
boolean
C0006826 (UMLS CUI [1,1])
C0460002 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0460002 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C0392752 (UMLS CUI [3,3])
C0006826 (UMLS CUI [4,1])
C0332291 (UMLS CUI [4,2])
C0277556 (UMLS CUI [4,3])
C0205276 (UMLS CUI [4,4])
C0006826 (UMLS CUI [5,1])
C0332291 (UMLS CUI [5,2])
C0027627 (UMLS CUI [5,3])
Secondary hypertension
Item
evidence of a secondary form of hypertension, including but not limited to any of the following:
boolean
C0155616 (UMLS CUI [1])
Aortic coarctation
Item
coarctation of the aorta
boolean
C0003492 (UMLS CUI [1])
Hyperaldosteronism
Item
hyperaldosteronism
boolean
C0020428 (UMLS CUI [1])
Unilateral renal artery stenosis | Bilateral renal artery stenosis
Item
unilateral or bilateral renal artery stenosis
boolean
C0856759 (UMLS CUI [1])
C0856760 (UMLS CUI [2])
Cushing's disease
Item
cushing's disease
boolean
C0221406 (UMLS CUI [1])
Polycystic Kidney Disease
Item
polycystic kidney disease
boolean
C0022680 (UMLS CUI [1])
Pheochromocytoma
Item
pheochromocytoma
boolean
C0031511 (UMLS CUI [1])
Hypertensive Retinopathy Grade
Item
known keith-wagener grade iii or iv hypertensive retinopathy.
boolean
C0152132 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Angioedema Due to Angiotensin II receptor antagonist | Angioedema due to angiotensin-converting-enzyme inhibitor
Item
history of angioedema due to usage of an arb or ace inhibitor.
boolean
C0002994 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0521942 (UMLS CUI [1,3])
C1304495 (UMLS CUI [2])
Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Heart failure New York Heart Association Classification | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Angina, Unstable | Myocardial Infarction
Item
history of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, heart failure (nyha class ii-iv), coronary bypass graft surgery (cabg), percutaneous coronary intervention (pci), unstable angina pectoris, or myocardial infarction in the last 12 months
boolean
C0151620 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0010055 (UMLS CUI [5])
C1532338 (UMLS CUI [6])
C0002965 (UMLS CUI [7])
C0027051 (UMLS CUI [8])
Eligibility Criteria Study Protocol
Item
other protocol defined inclusion/exclusion criteria applied
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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