ID

41001

Beskrivning

Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB and Hydrochlorothiazide in Patients With Grade I or II Essential Hypertension.; ODM derived from: https://clinicaltrials.gov/show/NCT02072330

Länk

https://clinicaltrials.gov/show/NCT02072330

Nyckelord

Versioner (1)
  1. 2020-06-10 2020-06-10 -
Rättsinnehavare

See clinicaltrials.gov

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10 juni 2020

DOI

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Creative Commons BY 4.0
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Eligibility Grade I or II Essential Hypertension NCT02072330

Engelsk

Eligibility Grade I or II Essential Hypertension NCT02072330

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. grade i or ii essential hypertension.
Beskrivning

Essential Hypertension Grade

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C0441800
2. an office sitting systolic blood pressure of ≥ 150 and < 180 mmhg, and an office sitting diastolic blood pressure of ≥ 95 and < 110 mmhg during the placebo run-in period at week −2 and week 0.
Beskrivning

Sitting systolic blood pressure | Sitting diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C1319893
UMLS CUI [2]
C1319894
3. male or female aged 20 years or older at the time of providing informed consent.
Beskrivning

Age | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
4. outpatient.
Beskrivning

Outpatient

Datatyp

boolean

Alias
UMLS CUI [1]
C0029921
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. secondary hypertension, grade iii hypertension or malignant hypertension.
Beskrivning

Secondary hypertension | Hypertensive disease Grade | Malignant Hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0441800
UMLS CUI [3]
C0020540
2. an office sitting systolic blood pressure of ≥160 mmhg or sitting diastolic blood pressure of ≥100 mmhg recorded while on combined therapy with 3 or more antihypertensives within 4 weeks prior to the initiation of the placebo run-in period and at week −4.
Beskrivning

Sitting systolic blood pressure | Sitting diastolic blood pressure | Combined Modality Therapy | Antihypertensive Agents Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C1319893
UMLS CUI [2]
C1319894
UMLS CUI [3]
C0009429
UMLS CUI [4,1]
C0003364
UMLS CUI [4,2]
C1265611
3 evident white coat hypertension or white coat phenomenon. 4. day-night reversed lifestyle, such as night-time workers. 5. sleep apnea syndrome requiring treatment. 6. have any of the cardiovascular disease or symptoms listed below:
Beskrivning

White Coat Hypertension | Other Coding | Night shift worker | Sleep Apnea Syndrome Treatment required for | Cardiovascular Disease | Cardiovascular symptoms

Datatyp

boolean

Alias
UMLS CUI [1]
C0262534
UMLS CUI [2]
C3846158
UMLS CUI [3]
C0555008
UMLS CUI [4,1]
C0037315
UMLS CUI [4,2]
C0332121
UMLS CUI [5]
C0007222
UMLS CUI [6]
C0476270
heart disease: myocardial infarction (within 24 weeks before the placebo run-in period), coronary arterial revascularization (within 24 weeks before the placebo run-in period), severe valvular disease, atrial fibrillation, or following diseases which require medication: angina pectoris, congested heart failure, or arrhythmia.
Beskrivning

Heart Disease | Myocardial Infarction | Coronary revascularisation | Valvular disease Severe | Atrial Fibrillation | Disease Requirement Pharmaceutical Preparations | Angina Pectoris | Congestive heart failure | Cardiac Arrhythmia

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0877341
UMLS CUI [4,1]
C3258293
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0004238
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C0013227
UMLS CUI [7]
C0002962
UMLS CUI [8]
C0018802
UMLS CUI [9]
C0003811
cerebrovascular disease: cerebral infarction, cerebral hemorrhage (within 24 weeks before the placebo run-in period), or transient ischemic attack (within 24 weeks before the placebo run-in period).
Beskrivning

Cerebrovascular Disorder | Cerebral Infarction | Cerebral Hemorrhage | Transient Ischemic Attack

Datatyp

boolean

Alias
UMLS CUI [1]
C0007820
UMLS CUI [2]
C0007785
UMLS CUI [3]
C2937358
UMLS CUI [4]
C0007787
vascular diseases: peripheral arterial disease with intermittent claudication, artery dissection, aneurysm
Beskrivning

Vascular Diseases | Peripheral Arterial Disease | Intermittent Claudication | Arterial dissection | Aneurysm

Datatyp

boolean

Alias
UMLS CUI [1]
C0042373
UMLS CUI [2]
C1704436
UMLS CUI [3]
C0021775
UMLS CUI [4]
C0002949
UMLS CUI [5]
C0002940
advanced hypertensive retinopathy: bleeding, exudation, or papilledema (within 24 weeks before the placebo run-in period).
Beskrivning

Hypertensive Retinopathy Advanced | Hemorrhage | Exudation | Papilledema

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0152132
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0019080
UMLS CUI [3]
C0311437
UMLS CUI [4]
C0030353
7. clinically significant hepatic disorder. 8. clinically significant renal impairment. 9. significantly low or high potassium or sodium levels. 10. complicated by gout, or had a past history of gout within 24 weeks prior to the initiation of the placebo run-in period, or complicated by hyperuricemia requiring medication.
Beskrivning

Liver disease | Renal Insufficiency | Potassium low | Potassium increased | Sodium decreased | Sodium high | Complication Due to Gout | Gout | Complication Due to Hyperuricemia | Pharmaceutical Preparations Required

Datatyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0860866
UMLS CUI [4]
C0856882
UMLS CUI [5]
C0860871
UMLS CUI [6]
C0595879
UMLS CUI [7,1]
C0009566
UMLS CUI [7,2]
C0678226
UMLS CUI [7,3]
C0018099
UMLS CUI [8]
C0018099
UMLS CUI [9,1]
C0009566
UMLS CUI [9,2]
C0678226
UMLS CUI [9,3]
C0740394
UMLS CUI [10,1]
C0013227
UMLS CUI [10,2]
C1514873
11. diabetic subject on insulin treatment or poorly controlled type 2 diabetes mellitus.
Beskrivning

Diabetic | Insulin regime | Type II diabetes mellitus uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C0241863
UMLS CUI [2]
C0557978
UMLS CUI [3]
C2733146
12. have a malignant tumor.
Beskrivning

Malignant Neoplasm

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
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Similar models

Eligibility Grade I or II Essential Hypertension NCT02072330

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension Grade
Item
1. grade i or ii essential hypertension.
boolean
C0085580 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Sitting systolic blood pressure | Sitting diastolic blood pressure
Item
2. an office sitting systolic blood pressure of ≥ 150 and < 180 mmhg, and an office sitting diastolic blood pressure of ≥ 95 and < 110 mmhg during the placebo run-in period at week −2 and week 0.
boolean
C1319893 (UMLS CUI [1])
C1319894 (UMLS CUI [2])
Age | Informed Consent
Item
3. male or female aged 20 years or older at the time of providing informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Outpatient
Item
4. outpatient.
boolean
C0029921 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension | Hypertensive disease Grade | Malignant Hypertension
Item
1. secondary hypertension, grade iii hypertension or malignant hypertension.
boolean
C0155616 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C0020540 (UMLS CUI [3])
Sitting systolic blood pressure | Sitting diastolic blood pressure | Combined Modality Therapy | Antihypertensive Agents Quantity
Item
2. an office sitting systolic blood pressure of ≥160 mmhg or sitting diastolic blood pressure of ≥100 mmhg recorded while on combined therapy with 3 or more antihypertensives within 4 weeks prior to the initiation of the placebo run-in period and at week −4.
boolean
C1319893 (UMLS CUI [1])
C1319894 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0003364 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
White Coat Hypertension | Other Coding | Night shift worker | Sleep Apnea Syndrome Treatment required for | Cardiovascular Disease | Cardiovascular symptoms
Item
3 evident white coat hypertension or white coat phenomenon. 4. day-night reversed lifestyle, such as night-time workers. 5. sleep apnea syndrome requiring treatment. 6. have any of the cardiovascular disease or symptoms listed below:
boolean
C0262534 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
C0555008 (UMLS CUI [3])
C0037315 (UMLS CUI [4,1])
C0332121 (UMLS CUI [4,2])
C0007222 (UMLS CUI [5])
C0476270 (UMLS CUI [6])
Heart Disease | Myocardial Infarction | Coronary revascularisation | Valvular disease Severe | Atrial Fibrillation | Disease Requirement Pharmaceutical Preparations | Angina Pectoris | Congestive heart failure | Cardiac Arrhythmia
Item
heart disease: myocardial infarction (within 24 weeks before the placebo run-in period), coronary arterial revascularization (within 24 weeks before the placebo run-in period), severe valvular disease, atrial fibrillation, or following diseases which require medication: angina pectoris, congested heart failure, or arrhythmia.
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0877341 (UMLS CUI [3])
C3258293 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0004238 (UMLS CUI [5])
C0012634 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0013227 (UMLS CUI [6,3])
C0002962 (UMLS CUI [7])
C0018802 (UMLS CUI [8])
C0003811 (UMLS CUI [9])
Cerebrovascular Disorder | Cerebral Infarction | Cerebral Hemorrhage | Transient Ischemic Attack
Item
cerebrovascular disease: cerebral infarction, cerebral hemorrhage (within 24 weeks before the placebo run-in period), or transient ischemic attack (within 24 weeks before the placebo run-in period).
boolean
C0007820 (UMLS CUI [1])
C0007785 (UMLS CUI [2])
C2937358 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
Vascular Diseases | Peripheral Arterial Disease | Intermittent Claudication | Arterial dissection | Aneurysm
Item
vascular diseases: peripheral arterial disease with intermittent claudication, artery dissection, aneurysm
boolean
C0042373 (UMLS CUI [1])
C1704436 (UMLS CUI [2])
C0021775 (UMLS CUI [3])
C0002949 (UMLS CUI [4])
C0002940 (UMLS CUI [5])
Hypertensive Retinopathy Advanced | Hemorrhage | Exudation | Papilledema
Item
advanced hypertensive retinopathy: bleeding, exudation, or papilledema (within 24 weeks before the placebo run-in period).
boolean
C0152132 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0019080 (UMLS CUI [2])
C0311437 (UMLS CUI [3])
C0030353 (UMLS CUI [4])
Liver disease | Renal Insufficiency | Potassium low | Potassium increased | Sodium decreased | Sodium high | Complication Due to Gout | Gout | Complication Due to Hyperuricemia | Pharmaceutical Preparations Required
Item
7. clinically significant hepatic disorder. 8. clinically significant renal impairment. 9. significantly low or high potassium or sodium levels. 10. complicated by gout, or had a past history of gout within 24 weeks prior to the initiation of the placebo run-in period, or complicated by hyperuricemia requiring medication.
boolean
C0023895 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0860866 (UMLS CUI [3])
C0856882 (UMLS CUI [4])
C0860871 (UMLS CUI [5])
C0595879 (UMLS CUI [6])
C0009566 (UMLS CUI [7,1])
C0678226 (UMLS CUI [7,2])
C0018099 (UMLS CUI [7,3])
C0018099 (UMLS CUI [8])
C0009566 (UMLS CUI [9,1])
C0678226 (UMLS CUI [9,2])
C0740394 (UMLS CUI [9,3])
C0013227 (UMLS CUI [10,1])
C1514873 (UMLS CUI [10,2])
Diabetic | Insulin regime | Type II diabetes mellitus uncontrolled
Item
11. diabetic subject on insulin treatment or poorly controlled type 2 diabetes mellitus.
boolean
C0241863 (UMLS CUI [1])
C0557978 (UMLS CUI [2])
C2733146 (UMLS CUI [3])
Malignant Neoplasm
Item
12. have a malignant tumor.
boolean
C0006826 (UMLS CUI [1])
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