0 Ratings
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

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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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