ID

29944

Description

Blood Pressure Lowering of Aliskiren Hydrochlorothiazide (HCTZ) Versus Amlodipine in Stage 2 Hypertension in African Americans; ODM derived from: https://clinicaltrials.gov/show/NCT00739596

Link

https://clinicaltrials.gov/show/NCT00739596

Keywords

Versions (2)
  1. 4/29/18 4/29/18 -
  2. 4/29/18 4/29/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 29, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00739596

English

Eligibility Hypertension NCT00739596

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
Description

Study Subject Participation Status eligible | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548635
UMLS CUI [2]
C0021430
men or women 18 years and older of african american background; self identified
Description

Age | African American

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0085756
patients with stage 2 hypertension. patients must have a 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 (mssbp ≥ 200 mmhg and/or msdbp ≥ 110 mmhg) at any visit.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0005824
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives whichever is longer.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
history of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (ccbs or thiazide diuretics) as the study drugs.
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Therapeutic class Same | Calcium Channel Blockers | Thiazide Diuretics

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C3858838
UMLS CUI [2,4]
C0445247
UMLS CUI [3]
C0006684
UMLS CUI [4]
C0012802
long qt syndrome or qtc > 450 msec for males and > 470 msec for females at screening.
Description

Long QT Syndrome | QTc Duration | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0023976
UMLS CUI [2,1]
C0860814
UMLS CUI [2,2]
C0449238
UMLS CUI [3]
C0079399
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 Independent of Local Neoplasm Recurrence | Malignant Neoplasms Independent of Neoplasm Metastasis | Exception Basal cell carcinoma Localized

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0027643
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332291
UMLS CUI [2,3]
C0027627
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C0392752
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 (> 5 miu/ml)
Description

Pregnancy | Breast Feeding | HCG pregnancy test Positive

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0546577
UMLS CUI [3,2]
C1514241
women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they are using two birth control methods. the two methods can be a double barrier method or a barrier method plus a hormonal method.
Description

Childbearing Potential Contraceptive methods Quantity | Barrier Contraception Double | Contraception, Barrier | Hormonal contraception | Gender Coitus Excluded | Gender Partner had vasectomy | Gender Partner Male sterilization

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0004764
UMLS CUI [2,2]
C0205173
UMLS CUI [3]
C0004764
UMLS CUI [4]
C2985296
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C0009253
UMLS CUI [5,3]
C0332196
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0420842
UMLS CUI [7,1]
C0079399
UMLS CUI [7,2]
C0682323
UMLS CUI [7,3]
C0024559
1. adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent. reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
Description

Contraceptive methods | Contraception, Barrier | Vaginal contraceptive diaphragm | Condoms Partner | Intrauterine Devices, Copper | Intrauterine Devices, Medicated | Contraceptive Sponge | Spermatocidal Agents | Contraceptives, Oral, Hormonal

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0004764
UMLS CUI [3]
C0042241
UMLS CUI [4,1]
C0677582
UMLS CUI [4,2]
C0682323
UMLS CUI [5]
C0021901
UMLS CUI [6]
C0021902
UMLS CUI [7]
C0183461
UMLS CUI [8]
C0037862
UMLS CUI [9]
C0009907
2. women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum fsh levels > 40 miu/ml [and estradiol < 20 pg/ml] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
Description

Postmenopausal state | Gender Childbearing Potential Absent | Amenorrhea Natural Duration | Age | Vasomotor symptom | Serum follicle stimulating hormone measurement | Estradiol measurement | Bilateral oophorectomy | Hysterectomy | Ovariectomy Alone | Status Reproductive Finding of hormone level

Data type

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C3831118
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0002453
UMLS CUI [3,2]
C0205296
UMLS CUI [3,3]
C0449238
UMLS CUI [4]
C0001779
UMLS CUI [5]
C0750152
UMLS CUI [6]
C0455276
UMLS CUI [7]
C0337434
UMLS CUI [8]
C0278321
UMLS CUI [9]
C0020699
UMLS CUI [10,1]
C0029936
UMLS CUI [10,2]
C0205171
UMLS CUI [11,1]
C0449438
UMLS CUI [11,2]
C0035150
UMLS CUI [11,3]
C1287355
history or evidence of a secondary form of hypertension.
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
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 cerebrovascular accident, transient ischemic cerebral attack (tia), heart failure (nyha class ii-iv), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (pci) in the last 12 months.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0010055
UMLS CUI [6]
C1532338
current angina pectoris requiring pharmacological therapy.
Description

Angina Pectoris Requirement Pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013216
other protocol-defined inclusion/exclusion criteria may apply
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 NCT00739596

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status eligible | Informed Consent
Item
patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
boolean
C2348568 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Age | African American
Item
men or women 18 years and older of african american background; self identified
boolean
C0001779 (UMLS CUI [1])
C0085756 (UMLS CUI [2])
Hypertensive disease Stage | Sitting systolic blood pressure mean
Item
patients with stage 2 hypertension. patients must have a 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 determination | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
office blood pressure measured by cuff (mssbp ≥ 200 mmhg and/or msdbp ≥ 110 mmhg) at any visit.
boolean
C0005824 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Investigational New Drugs
Item
use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives whichever is longer.
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Therapeutic class Same | Calcium Channel Blockers | Thiazide Diuretics
Item
history of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (ccbs or thiazide diuretics) as the study drugs.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C3858838 (UMLS CUI [2,3])
C0445247 (UMLS CUI [2,4])
C0006684 (UMLS CUI [3])
C0012802 (UMLS CUI [4])
Long QT Syndrome | QTc Duration | Gender
Item
long qt syndrome or qtc > 450 msec for males and > 470 msec for females at screening.
boolean
C0023976 (UMLS CUI [1])
C0860814 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3])
Malignant Neoplasms Independent of Local Neoplasm Recurrence | Malignant Neoplasms Independent of Neoplasm Metastasis | Exception Basal cell carcinoma Localized
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])
C0332291 (UMLS CUI [1,2])
C0027643 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C0392752 (UMLS CUI [3,3])
Pregnancy | Breast Feeding | HCG pregnancy test Positive
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 (> 5 miu/ml)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0546577 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Childbearing Potential Contraceptive methods Quantity | Barrier Contraception Double | Contraception, Barrier | Hormonal contraception | Gender Coitus Excluded | Gender Partner had vasectomy | Gender Partner Male sterilization
Item
women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they are using two birth control methods. the two methods can be a double barrier method or a barrier method plus a hormonal method.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0004764 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C0004764 (UMLS CUI [3])
C2985296 (UMLS CUI [4])
C0079399 (UMLS CUI [5,1])
C0009253 (UMLS CUI [5,2])
C0332196 (UMLS CUI [5,3])
C0079399 (UMLS CUI [6,1])
C0420842 (UMLS CUI [6,2])
C0079399 (UMLS CUI [7,1])
C0682323 (UMLS CUI [7,2])
C0024559 (UMLS CUI [7,3])
Contraceptive methods | Contraception, Barrier | Vaginal contraceptive diaphragm | Condoms Partner | Intrauterine Devices, Copper | Intrauterine Devices, Medicated | Contraceptive Sponge | Spermatocidal Agents | Contraceptives, Oral, Hormonal
Item
1. adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent. reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
boolean
C0700589 (UMLS CUI [1])
C0004764 (UMLS CUI [2])
C0042241 (UMLS CUI [3])
C0677582 (UMLS CUI [4,1])
C0682323 (UMLS CUI [4,2])
C0021901 (UMLS CUI [5])
C0021902 (UMLS CUI [6])
C0183461 (UMLS CUI [7])
C0037862 (UMLS CUI [8])
C0009907 (UMLS CUI [9])
Postmenopausal state | Gender Childbearing Potential Absent | Amenorrhea Natural Duration | Age | Vasomotor symptom | Serum follicle stimulating hormone measurement | Estradiol measurement | Bilateral oophorectomy | Hysterectomy | Ovariectomy Alone | Status Reproductive Finding of hormone level
Item
2. women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum fsh levels > 40 miu/ml [and estradiol < 20 pg/ml] or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
boolean
C0232970 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0002453 (UMLS CUI [3,1])
C0205296 (UMLS CUI [3,2])
C0449238 (UMLS CUI [3,3])
C0001779 (UMLS CUI [4])
C0750152 (UMLS CUI [5])
C0455276 (UMLS CUI [6])
C0337434 (UMLS CUI [7])
C0278321 (UMLS CUI [8])
C0020699 (UMLS CUI [9])
C0029936 (UMLS CUI [10,1])
C0205171 (UMLS CUI [10,2])
C0449438 (UMLS CUI [11,1])
C0035150 (UMLS CUI [11,2])
C1287355 (UMLS CUI [11,3])
Secondary hypertension
Item
history or evidence of a secondary form of hypertension.
boolean
C0155616 (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])
Cerebrovascular accident | Transient Ischemic Attack | Heart failure New York Heart Association Classification | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
history of cerebrovascular accident, transient ischemic cerebral attack (tia), heart failure (nyha class ii-iv), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (pci) in the last 12 months.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0018801 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C1532338 (UMLS CUI [6])
Angina Pectoris Requirement Pharmacotherapy
Item
current angina pectoris requiring pharmacological therapy.
boolean
C0002962 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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