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])
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])