ID

29940

Description

Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00705575

Link

https://clinicaltrials.gov/show/NCT00705575

Keywords

Versions (1)
  1. 4/28/18 4/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 28, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00705575

English

Eligibility Hypertension NCT00705575

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients ≥18 years of age.
Description

Outpatients | Age

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
patients with a diagnosis of stage ii hypertension, defined as mean sitting systolic blood pressure (mssbp) ≥ 160 mmhg and < 180 mmhg at visit 2.
Description

Hypertensive disease Stage | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0699749
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
severe hypertension defined as mssbp ≥ 180 mmhg and/or mean sitting diastolic blood pressure (msdbp) ≥ 110 mmhg.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
secondary form of hypertension.
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
current diagnosis of heart failure (new york heart association [nyha] class ii-iv).
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates).
Description

Angina Pectoris Requirement Pharmacotherapy | Exception Nitrates Oral | Exception Nitrates Topical

Data type

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013216
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0028125
UMLS CUI [2,3]
C1527415
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0028125
UMLS CUI [3,3]
C1522168
second or third degree heart block without a pacemaker.
Description

Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent

Data type

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3,1]
C0030163
UMLS CUI [3,2]
C0332197
concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to visit 1.
Description

Cardiac Arrhythmia Life Threatening | ARRHYTHMIA SYMPTOMATIC | Atrial Fibrillation | Atrial Flutter

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0741212
UMLS CUI [3]
C0004238
UMLS CUI [4]
C0004239
clinically significant valvular heart disease.
Description

Heart valve disease

Data type

boolean

Alias
UMLS CUI [1]
C0018824
previous history of hypertensive encephalopathy or stroke, transcient ischemic attack (tia), heart attack, coronary bypass surgery or any pci.
Description

Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0151620
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0027051
UMLS CUI [5]
C0010055
UMLS CUI [6]
C1532338
known keith-wagener grade iii or iv hypertensive retinopathy.
Description

Hypertensive Retinopathy Grade

Data type

boolean

Alias
UMLS CUI [1,1]
C0152132
UMLS CUI [1,2]
C0441800
in the month prior to visit 1, patients on combination antihypertensive therapy that includes more than 2 classes of antihypertensive medications.
Description

Antihypertensive therapy Combined | Antihypertensive Agents Class Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0585941
UMLS CUI [1,2]
C0205195
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0456387
UMLS CUI [2,3]
C1265611
patients on combined antihypertensive medication that contain two classes of antihypertensive medications are considered to take two antihypertensive medications.
Description

Antihypertensive Agents Combined | Antihypertensive Agents Class Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0205195
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0456387
UMLS CUI [2,3]
C1265611
inability to discontinue prior antihypertensive or other cv medications as required by the protocol.
Description

Antihypertensive Agents Unable to discontinue | Cardiovascular Agents Unable to discontinue

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1548265
UMLS CUI [2,1]
C0007220
UMLS CUI [2,2]
C1548265
patients with type 1 diabetes mellitus.
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
patients with type 2 diabetes mellitus not well controlled .
Description

Non-Insulin-Dependent Diabetes Mellitus Poorly controlled

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C3853134
elevated serum potassium (over 5.3 meq/l (mmol/l).
Description

Serum potassium increased

Data type

boolean

Alias
UMLS CUI [1]
C0553704
any surgical or medical condition or the use of any medication which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.
Description

Operative Surgical Procedures Changing Absorption Investigational New Drugs | Operative Surgical Procedures Changing Distribution Investigational New Drugs | Operative Surgical Procedures Changing Metabolism Investigational New Drugs | Operative Surgical Procedures Changing Elimination Investigational New Drugs | Medical condition Changing Absorption Investigational New Drugs | Medical condition Changing Distribution Investigational New Drugs | Medical condition Changing Metabolism Investigational New Drugs | Medical condition Changing Elimination Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C1378698
UMLS CUI [2,4]
C0013230
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0025519
UMLS CUI [3,4]
C0013230
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0392747
UMLS CUI [4,3]
C0683141
UMLS CUI [4,4]
C0013230
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0392747
UMLS CUI [5,3]
C0237442
UMLS CUI [5,4]
C0013230
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0392747
UMLS CUI [6,3]
C1378698
UMLS CUI [6,4]
C0013230
UMLS CUI [7,1]
C3843040
UMLS CUI [7,2]
C0392747
UMLS CUI [7,3]
C0025519
UMLS CUI [7,4]
C0013230
UMLS CUI [8,1]
C3843040
UMLS CUI [8,2]
C0392747
UMLS CUI [8,3]
C0683141
UMLS CUI [8,4]
C0013230
other protocol-defined inclusion/exclusion criteria may apply.
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Hypertension NCT00705575

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
outpatients ≥18 years of age.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Hypertensive disease Stage | Sitting systolic blood pressure mean
Item
patients with a diagnosis of stage ii hypertension, defined as mean sitting systolic blood pressure (mssbp) ≥ 160 mmhg and < 180 mmhg at visit 2.
boolean
C0020538 (UMLS CUI [1,1])
C0699749 (UMLS CUI [1,2])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hypertension, severe | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
severe hypertension defined as mssbp ≥ 180 mmhg and/or mean sitting diastolic blood pressure (msdbp) ≥ 110 mmhg.
boolean
C4013784 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Secondary hypertension
Item
secondary form of hypertension.
boolean
C0155616 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
current diagnosis of heart failure (new york heart association [nyha] class ii-iv).
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Angina Pectoris Requirement Pharmacotherapy | Exception Nitrates Oral | Exception Nitrates Topical
Item
current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates).
boolean
C0002962 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0028125 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0028125 (UMLS CUI [3,2])
C1522168 (UMLS CUI [3,3])
Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent
Item
second or third degree heart block without a pacemaker.
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0030163 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Cardiac Arrhythmia Life Threatening | ARRHYTHMIA SYMPTOMATIC | Atrial Fibrillation | Atrial Flutter
Item
concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to visit 1.
boolean
C0003811 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0741212 (UMLS CUI [2])
C0004238 (UMLS CUI [3])
C0004239 (UMLS CUI [4])
Heart valve disease
Item
clinically significant valvular heart disease.
boolean
C0018824 (UMLS CUI [1])
Hypertensive Encephalopathy | Cerebrovascular accident | Transient Ischemic Attack | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
previous history of hypertensive encephalopathy or stroke, transcient ischemic attack (tia), heart attack, coronary bypass surgery or any pci.
boolean
C0151620 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C1532338 (UMLS CUI [6])
Hypertensive Retinopathy Grade
Item
known keith-wagener grade iii or iv hypertensive retinopathy.
boolean
C0152132 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Antihypertensive therapy Combined | Antihypertensive Agents Class Quantity
Item
in the month prior to visit 1, patients on combination antihypertensive therapy that includes more than 2 classes of antihypertensive medications.
boolean
C0585941 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Antihypertensive Agents Combined | Antihypertensive Agents Class Quantity
Item
patients on combined antihypertensive medication that contain two classes of antihypertensive medications are considered to take two antihypertensive medications.
boolean
C0003364 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Antihypertensive Agents Unable to discontinue | Cardiovascular Agents Unable to discontinue
Item
inability to discontinue prior antihypertensive or other cv medications as required by the protocol.
boolean
C0003364 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
C0007220 (UMLS CUI [2,1])
C1548265 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent
Item
patients with type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Poorly controlled
Item
patients with type 2 diabetes mellitus not well controlled .
boolean
C0011860 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
Serum potassium increased
Item
elevated serum potassium (over 5.3 meq/l (mmol/l).
boolean
C0553704 (UMLS CUI [1])
Operative Surgical Procedures Changing Absorption Investigational New Drugs | Operative Surgical Procedures Changing Distribution Investigational New Drugs | Operative Surgical Procedures Changing Metabolism Investigational New Drugs | Operative Surgical Procedures Changing Elimination Investigational New Drugs | Medical condition Changing Absorption Investigational New Drugs | Medical condition Changing Distribution Investigational New Drugs | Medical condition Changing Metabolism Investigational New Drugs | Medical condition Changing Elimination Investigational New Drugs
Item
any surgical or medical condition or the use of any medication which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.
boolean
C0543467 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C1378698 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C0543467 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0025519 (UMLS CUI [3,3])
C0013230 (UMLS CUI [3,4])
C0543467 (UMLS CUI [4,1])
C0392747 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
C0013230 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C0392747 (UMLS CUI [5,2])
C0237442 (UMLS CUI [5,3])
C0013230 (UMLS CUI [5,4])
C3843040 (UMLS CUI [6,1])
C0392747 (UMLS CUI [6,2])
C1378698 (UMLS CUI [6,3])
C0013230 (UMLS CUI [6,4])
C3843040 (UMLS CUI [7,1])
C0392747 (UMLS CUI [7,2])
C0025519 (UMLS CUI [7,3])
C0013230 (UMLS CUI [7,4])
C3843040 (UMLS CUI [8,1])
C0392747 (UMLS CUI [8,2])
C0683141 (UMLS CUI [8,3])
C0013230 (UMLS CUI [8,4])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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