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])
Outpatients | Age
Item
male or female outpatients ≥ 18 years old.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Systolic hypertension Stage | Sitting systolic blood pressure mean
Item
patients with stage 2 systolic hypertension. patients must have a mssbp ≥160 mmhg and <200 mmhg at study visit 5 (randomization).
boolean
C0221155 (UMLS CUI [1,1])
C0699749 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Systolic hypertension Stage | Metabolic Syndrome Component Quantity Fulfill
Item
patients who have stage 2 systolic hypertension that meet at least 2 additional components of the metabolic syndrome as defined by the national *cholesterol education program (ncep) criteria:
boolean
C0221155 (UMLS CUI [1,1])
C0699749 (UMLS CUI [1,2])
C0524620 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1550543 (UMLS CUI [2,4])
Obesity, Abdominal | Waist Circumference | Gender
Item
abdominal obesity (waist circumference > than 102 cm for men and > 88 cm for women)
boolean
C0311277 (UMLS CUI [1])
C0455829 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Triglycerides measurement | Therapeutic procedure Condition Specified
Item
current triglycerides ≥ 150 mg/dl or medical treatment for this condition.
boolean
C0202236 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0348080 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Serum HDL cholesterol measurement | Gender | Therapeutic procedure Condition Specified
Item
current hdl- cholesterol <40 mg/dl in men and <50 mg/dl in women or medical treatment for this condition.
boolean
C0428472 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0348080 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
Glucose measurement, fasting
Item
fasting glucose >100 mg/dl and <126 mg/dl
boolean
C0202045 (UMLS CUI [1])
Blood pressure determination | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean
Item
office blood pressure measured by cuff (msdbp ≥ 110 mmhg and or mssbp ≥ 200 mmhg) at any visit.
boolean
C0005824 (UMLS CUI [1])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319893 (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 of enrollment, whichever is longer.
boolean
C0013230 (UMLS CUI [1])
Aliskiren | Hydrochlorothiazide | Combined Modality Therapy Dose Stable | Study Subject Participation Status
Item
use of aliskiren and/or a fixed dose combination of aliskiren hctz or participation in a clinical trial that had aliskiren and/or aliskiren hctz as treatment within 30 days of visit 1.
boolean
C1120110 (UMLS CUI [1])
C0020261 (UMLS CUI [2])
C0009429 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C2348568 (UMLS CUI [4])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Therapeutic class Similar | Diuretics | Renin inhibitor
Item
history of hypersensitivity to any of the medications or to drugs belonging to a similar therapeutic class (diuretics or renin inhibitors) 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])
C2348205 (UMLS CUI [2,4])
C0012798 (UMLS CUI [3])
C1960108 (UMLS CUI [4])
Secondary hypertension
Item
history or evidence of secondary form of hypertension.
boolean
C0155616 (UMLS CUI [1])
Refractory hypertension | Pharmacotherapy Triple Unresponsive to Treatment | Pharmaceutical Preparations Maximum Tolerated Dose | Diuretics | Blood Pressure Goal failed | Combined Modality Therapy | Pharmaceutical Preparations Quantity Dose Stable
Item
refractory hypertension, defined as unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90mmhg). therapy with a fixed dose combination of two active substances represent two drugs.
boolean
C0860493 (UMLS CUI [1])
C0013216 (UMLS CUI [2,1])
C0205174 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0752079 (UMLS CUI [3,2])
C0012798 (UMLS CUI [4])
C0005823 (UMLS CUI [5,1])
C0679840 (UMLS CUI [5,2])
C0231175 (UMLS CUI [5,3])
C0009429 (UMLS CUI [6])
C0013227 (UMLS CUI [7,1])
C1265611 (UMLS CUI [7,2])
C0178602 (UMLS CUI [7,3])
C0205360 (UMLS CUI [7,4])
Antihypertensive Agents Quantity
Item
patients on 4 or more antihypertensive medications.
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])