ID

17699

Beschrijving

Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Patients With Hypertension.; ODM derived from: https://clinicaltrials.gov/show/NCT00409760

Link

https://clinicaltrials.gov/show/NCT00409760

Trefwoorden

Versies (1)
  1. 28-09-16 28-09-16 -
Geüploaded op

28 september 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypertension NCT00409760

Engels

Eligibility Hypertension NCT00409760

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients 18 years and older.
Beschrijving

Outpatients | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
male or female patients are eligible.
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
female patients must be either post-menopausal for one year or surgically sterile, or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. hormonal contraceptive use is disallowed.
Beschrijving

Gender | Postmenopausal state | Female Sterilization | Contraceptive methods | Contraception, Barrier | Vaginal Spermicides | Intrauterine Devices | Contraceptives, Oral, Hormonal

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0700589
UMLS CUI [5]
C0004764
UMLS CUI [6]
C0087145
UMLS CUI [7]
C0021900
UMLS CUI [8]
C0009907
patients with mild to moderate essential diastolic hypertension (grades 1 and 2 who classification) measured by calibrated standard sphygmomanometer.
Beschrijving

essential diastolic hypertension Mild | essential diastolic hypertension Moderate | Measurement Sphygmomanometer Standard

Datatype

boolean

Alias
UMLS CUI [1,1]
C3694763
UMLS CUI [1,2]
C2945599
UMLS CUI [2,1]
C3694763
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C0242485
UMLS CUI [3,2]
C0183427
UMLS CUI [3,3]
C1442989
patients must have a msdbp >= 90 mmhg and < 110 mmhg at visit 1 (week -2 to -4), and a msdbp >= 95 mmhg and < 110 mmhg at visit 2 (week 0).
Beschrijving

Sitting diastolic blood pressure mean visit 1 | Sitting diastolic blood pressure mean visit 2

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C3842539
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [2,3]
C3842538
patients must have an absolute difference of =< 10 mmhg in their average sitting diastolic blood pressure between visits 1 and 2.
Beschrijving

Sitting diastolic blood pressure Average | Difference Absolute visit 1 visit 2

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C1510992
UMLS CUI [2,1]
C1705242
UMLS CUI [2,2]
C0205344
UMLS CUI [2,3]
C3842539
UMLS CUI [2,4]
C3842538
patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
Beschrijving

Compliance behavior | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension (grade 3 who classification; msdbp >=110 mmhg diastolic and/or mssbp >= 180 mmhg systolic).
Beschrijving

Hypertension, severe | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
inability to discontinue all prior anti-hypertensive medications safely for a period of 14 weeks).
Beschrijving

Antihypertensive Agents Discontinue Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1299582
known keith-wagener grade iii or iv hypertensive retinopathy.
Beschrijving

Retinopathy hypertensive grade 3 | Retinopathy hypertensive grade 4

Datatype

boolean

Alias
UMLS CUI [1]
C0857534
UMLS CUI [2]
C0857415
history of hypertensive encephalopathy or cerebrovascular accident at anytime prior to visit 1 (week -2 to -4).
Beschrijving

Hypertensive Encephalopathy | Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0151620
UMLS CUI [2]
C0038454
transient ischemic cerebral attack during the last 12 months prior to visit 1 (week-2 to -4).
Beschrijving

Transient Ischemic Attack

Datatype

boolean

Alias
UMLS CUI [1]
C0007787
evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral renal artery stenosis, or pheochromocytoma, etc.
Beschrijving

Secondary hypertension Evidence of | Aortic coarctation | Hyperaldosteronism | Unilateral renal artery stenosis | Pheochromocytoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0155616
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0003492
UMLS CUI [3]
C0020428
UMLS CUI [4]
C0856759
UMLS CUI [5]
C0031511
type 1 diabetes mellitus.
Beschrijving

Diabetes Mellitus, Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
type 2 diabetes mellitus with poor glucose control as defined by fasting glycosylated hemoglobin (hba1c) >8% at visit 1 (week -2 to -4).
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | GLUCOSE CONTROL Poor | Glycosylated hemoglobin A Fasting

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0726398
UMLS CUI [2,2]
C0542537
UMLS CUI [3,1]
C0019018
UMLS CUI [3,2]
C0015663
administration of any agent indicated for the treatment of hypertension within a minimum 4 weeks prior to randomization into the study (visit 2, week 0), with the permitted exception of those anti-hypertensive medications requiring tapering down commencing at visit 0 (week -4 to -6).
Beschrijving

Antihypertensive Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0003364
known or suspected contraindications, including history of allergy to angiotensin receptor blockers or calcium channel blockers.
Beschrijving

Medical contraindication | Hypersensitivity Angiotensin II receptor antagonist | Hypersensitivity Calcium Channel Blockers

Datatype

boolean

Alias
UMLS CUI [1]
C1301624
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0521942
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0006684
other protocol-defined inclusion/exclusion criteria may apply
Beschrijving

Inclusion criteria Study Protocol | Exclusion Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C2348563
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C2348563
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Similar models

Eligibility Hypertension NCT00409760

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
outpatients 18 years and older.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender
Item
male or female patients are eligible.
boolean
C0079399 (UMLS CUI [1])
Gender | Postmenopausal state | Female Sterilization | Contraceptive methods | Contraception, Barrier | Vaginal Spermicides | Intrauterine Devices | Contraceptives, Oral, Hormonal
Item
female patients must be either post-menopausal for one year or surgically sterile, or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. hormonal contraceptive use is disallowed.
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
C0004764 (UMLS CUI [5])
C0087145 (UMLS CUI [6])
C0021900 (UMLS CUI [7])
C0009907 (UMLS CUI [8])
essential diastolic hypertension Mild | essential diastolic hypertension Moderate | Measurement Sphygmomanometer Standard
Item
patients with mild to moderate essential diastolic hypertension (grades 1 and 2 who classification) measured by calibrated standard sphygmomanometer.
boolean
C3694763 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C3694763 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0242485 (UMLS CUI [3,1])
C0183427 (UMLS CUI [3,2])
C1442989 (UMLS CUI [3,3])
Sitting diastolic blood pressure mean visit 1 | Sitting diastolic blood pressure mean visit 2
Item
patients must have a msdbp >= 90 mmhg and < 110 mmhg at visit 1 (week -2 to -4), and a msdbp >= 95 mmhg and < 110 mmhg at visit 2 (week 0).
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C3842539 (UMLS CUI [1,3])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C3842538 (UMLS CUI [2,3])
Sitting diastolic blood pressure Average | Difference Absolute visit 1 visit 2
Item
patients must have an absolute difference of =< 10 mmhg in their average sitting diastolic blood pressure between visits 1 and 2.
boolean
C1319894 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
C1705242 (UMLS CUI [2,1])
C0205344 (UMLS CUI [2,2])
C3842539 (UMLS CUI [2,3])
C3842538 (UMLS CUI [2,4])
Compliance behavior | Informed Consent
Item
patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
boolean
C1321605 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hypertension, severe | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
severe hypertension (grade 3 who classification; msdbp >=110 mmhg diastolic and/or mssbp >= 180 mmhg systolic).
boolean
C4013784 (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 Discontinue Unable
Item
inability to discontinue all prior anti-hypertensive medications safely for a period of 14 weeks).
boolean
C0003364 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Retinopathy hypertensive grade 3 | Retinopathy hypertensive grade 4
Item
known keith-wagener grade iii or iv hypertensive retinopathy.
boolean
C0857534 (UMLS CUI [1])
C0857415 (UMLS CUI [2])
Hypertensive Encephalopathy | Cerebrovascular accident
Item
history of hypertensive encephalopathy or cerebrovascular accident at anytime prior to visit 1 (week -2 to -4).
boolean
C0151620 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Transient Ischemic Attack
Item
transient ischemic cerebral attack during the last 12 months prior to visit 1 (week-2 to -4).
boolean
C0007787 (UMLS CUI [1])
Secondary hypertension Evidence of | Aortic coarctation | Hyperaldosteronism | Unilateral renal artery stenosis | Pheochromocytoma
Item
evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral renal artery stenosis, or pheochromocytoma, etc.
boolean
C0155616 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0003492 (UMLS CUI [2])
C0020428 (UMLS CUI [3])
C0856759 (UMLS CUI [4])
C0031511 (UMLS CUI [5])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | GLUCOSE CONTROL Poor | Glycosylated hemoglobin A Fasting
Item
type 2 diabetes mellitus with poor glucose control as defined by fasting glycosylated hemoglobin (hba1c) >8% at visit 1 (week -2 to -4).
boolean
C0011860 (UMLS CUI [1])
C0726398 (UMLS CUI [2,1])
C0542537 (UMLS CUI [2,2])
C0019018 (UMLS CUI [3,1])
C0015663 (UMLS CUI [3,2])
Antihypertensive Agents
Item
administration of any agent indicated for the treatment of hypertension within a minimum 4 weeks prior to randomization into the study (visit 2, week 0), with the permitted exception of those anti-hypertensive medications requiring tapering down commencing at visit 0 (week -4 to -6).
boolean
C0003364 (UMLS CUI [1])
Medical contraindication | Hypersensitivity Angiotensin II receptor antagonist | Hypersensitivity Calcium Channel Blockers
Item
known or suspected contraindications, including history of allergy to angiotensin receptor blockers or calcium channel blockers.
boolean
C1301624 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0521942 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0006684 (UMLS CUI [3,2])
Inclusion criteria Study Protocol | Exclusion Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1512693 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
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