ID

29965

Description

Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00797316

Link

https://clinicaltrials.gov/show/NCT00797316

Keywords

Versions (1)
  1. 4/30/18 4/30/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 30, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00797316

English

Eligibility Hypertension NCT00797316

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
Description

Study Subject Participation Status eligible | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548635
UMLS CUI [2]
C0021430
male or female outpatients ≥ 18 years old.
Description

Outpatients | Age

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
patients with stage 2 systolic hypertension. patients must have a mssbp ≥160 mmhg and <200 mmhg at study visit 5 (randomization).
Description

Systolic hypertension Stage | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C0221155
UMLS CUI [1,2]
C0699749
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
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:
Description

Systolic hypertension Stage | Metabolic Syndrome Component Quantity Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0221155
UMLS CUI [1,2]
C0699749
UMLS CUI [2,1]
C0524620
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C1550543
abdominal obesity (waist circumference > than 102 cm for men and > 88 cm for women)
Description

Obesity, Abdominal | Waist Circumference | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0311277
UMLS CUI [2]
C0455829
UMLS CUI [3]
C0079399
current triglycerides ≥ 150 mg/dl or medical treatment for this condition.
Description

Triglycerides measurement | Therapeutic procedure Condition Specified

Data type

boolean

Alias
UMLS CUI [1]
C0202236
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0348080
UMLS CUI [2,3]
C0205369
current hdl- cholesterol <40 mg/dl in men and <50 mg/dl in women or medical treatment for this condition.
Description

Serum HDL cholesterol measurement | Gender | Therapeutic procedure Condition Specified

Data type

boolean

Alias
UMLS CUI [1]
C0428472
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0348080
UMLS CUI [3,3]
C0205369
fasting glucose >100 mg/dl and <126 mg/dl
Description

Glucose measurement, fasting

Data type

boolean

Alias
UMLS CUI [1]
C0202045
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
office blood pressure measured by cuff (msdbp ≥ 110 mmhg and or mssbp ≥ 200 mmhg) at any visit.
Description

Blood pressure determination | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1]
C0005824
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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.
Description

Aliskiren | Hydrochlorothiazide | Combined Modality Therapy Dose Stable | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C1120110
UMLS CUI [2]
C0020261
UMLS CUI [3,1]
C0009429
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4]
C2348568
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.
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Therapeutic class Similar | Diuretics | Renin inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C3858838
UMLS CUI [2,4]
C2348205
UMLS CUI [3]
C0012798
UMLS CUI [4]
C1960108
history or evidence of secondary form of hypertension.
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0860493
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0205174
UMLS CUI [2,3]
C0205269
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0752079
UMLS CUI [4]
C0012798
UMLS CUI [5,1]
C0005823
UMLS CUI [5,2]
C0679840
UMLS CUI [5,3]
C0231175
UMLS CUI [6]
C0009429
UMLS CUI [7,1]
C0013227
UMLS CUI [7,2]
C1265611
UMLS CUI [7,3]
C0178602
UMLS CUI [7,4]
C0205360
patients on 4 or more antihypertensive medications.
Description

Antihypertensive Agents Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
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Similar models

Eligibility Hypertension NCT00797316

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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