Informed Consent
Item
1. ability to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Antihypertensive therapy Stop Ability | Patient Risk Absent
Item
3. ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
boolean
C0585941 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Sitting diastolic blood pressure Cuff
Item
4. seated cuff dbp of ? 95 mmhg at visit 2 (baseline)
boolean
C1319894 (UMLS CUI [1,1])
C0441107 (UMLS CUI [1,2])
Premenopausal state
Item
1. pre-menopausal women (last menstruation ? 1 year prior to start of run-in period) who:
boolean
C0232969 (UMLS CUI [1])
Female Sterilization Missing
Item
1. are not surgically sterile and/or
boolean
C0015787 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
Breast Feeding | Pregnancy
Item
2. are nursing or pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Inadequate | Pregnancy Tests Periodic Unwilling | Contraceptives, Oral | Contraceptive implant | Transdermal contraception | Injectable contraception | Intrauterine Devices
Item
3. are of child-bearing potential and are not practicing acceptable means of birth control, do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in studies of > 3-months duration. acceptable methods of birth control include oral, implantable, transdermal, or injectable contraceptives, and intra-uterine device (iud).
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0032976 (UMLS CUI [2,1])
C0332182 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0009905 (UMLS CUI [3])
C1657106 (UMLS CUI [4])
C1168146 (UMLS CUI [5])
C1262153 (UMLS CUI [6])
C0021900 (UMLS CUI [7])
Secondary hypertension | Secondary hypertension Suspected
Item
2. known or suspected secondary hypertension.
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
3. mean seated sbp >= 180 mmhg or mean seated dbp >= 120 mmhg during any clinic visit prior to randomization.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Liver Dysfunction Laboratory Results | Renal dysfunction Laboratory Results
Item
4. hepatic and/or renal dysfunction as defined by the following laboratory parameters:
boolean
C0086565 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C3279454 (UMLS CUI [2,1])
C1254595 (UMLS CUI [2,2])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
1. sgpt (alt) or sgot (ast) > 2 times the upper limit of normal range, or
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Creatinine measurement, serum | Creatinine clearance measurement
Item
2. serum creatinine > 3.0 mg/dl or creatinine clearance < 0.6 ml/sec.
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Bilateral renal artery stenosis | Renal Artery Stenosis Kidney Singular | Renal Artery Stenosis Kidney Transplantation Status post | Renal Artery Stenosis Kidney Quantity
Item
5. bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney.
boolean
C0856760 (UMLS CUI [1])
C0035067 (UMLS CUI [2,1])
C0022646 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0035067 (UMLS CUI [3,1])
C0022671 (UMLS CUI [3,2])
C0231290 (UMLS CUI [3,3])
C0035067 (UMLS CUI [4,1])
C0022646 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Hypokalemia | Hyperkalemia
Item
6. clinically relevant hypokalemia or hyperkalemia.
boolean
C0020621 (UMLS CUI [1])
C0020461 (UMLS CUI [2])
Hypovolemia uncorrected
Item
7. uncorrected volume depletion.
boolean
C0546884 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
Hyponatremia uncorrected
Item
8. uncorrected sodium depletion.
boolean
C0020625 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
Primary aldosteronism
Item
9. primary aldosteronism.
boolean
C1719312 (UMLS CUI [1])
Hereditary fructose intolerance
Item
10. hereditary fructose intolerance.
boolean
C0016751 (UMLS CUI [1])
Biliary Tract Diseases Obstructive | Cholestasis | Hepatic Insufficiency Moderate | Hepatic Insufficiency Severe
Item
11. biliary obstructive disorders, cholestatis or moderate to severe hepatic in sufficiency.
boolean
C0005424 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0008370 (UMLS CUI [2])
C1306571 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C1306571 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Angioedema Symptoms Characteristic | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
12. patients who have previously experienced symptoms characteristic of angioedema during treatment with ace inhibitors or angiotensin ii receptor antagonists.
boolean
C0002994 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1521970 (UMLS CUI [1,3])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
Substance Dependence
Item
13. history of drug or alcohol dependency within six months prior to start of run-in period.
boolean
C0038580 (UMLS CUI [1])
Pharmaceutical Preparations chronic Affecting Blood Pressure
Item
14. chronic administration of any medications known to affect blood pressure, exc
boolean
C0013227 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0005823 (UMLS CUI [1,4])