ID

17660

Description

Study to Compare the Effect of Valsartan vs Atenolol on Pro-thrombotic State in Hypertensive Patients.; ODM derived from: https://clinicaltrials.gov/show/NCT00171756

Link

https://clinicaltrials.gov/show/NCT00171756

Keywords

Versions (1)
  1. 9/27/16 9/27/16 -
Uploaded on

September 27, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00171756

English

Eligibility Hypertension NCT00171756

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, aged between 18 - 75 years of age inclusively.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
mild to moderate hypertension (msdbp >= 95 and >= 110 mmhg and / or mssbp >140mm hg) at visit 1, requiring pharmacological intervention. for newly diagnosed patients, hypertensive blood pressure values must be noted on at least two successive examinations prior to entry into the study. in addition, patients must require therapy despite having been following dietary & lifestyle advice for at least 3 months.
Description

Hypertension, mild | Hypertension, moderate | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean | Pharmacotherapy Patient need for | Examination of blood pressure Quantity | Therapeutic procedure Patient need for | Diet education | Lifestyle education

Data type

boolean

Alias
UMLS CUI [1]
C3276943
UMLS CUI [2]
C1969581
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
UMLS CUI [4,1]
C1319893
UMLS CUI [4,2]
C0444504
UMLS CUI [5,1]
C0013216
UMLS CUI [5,2]
C0686904
UMLS CUI [6,1]
C0476712
UMLS CUI [6,2]
C1265611
UMLS CUI [7,1]
C0087111
UMLS CUI [7,2]
C0686904
UMLS CUI [8]
C0204932
UMLS CUI [9]
C0730543
written informed consent to participate in the study, prior to any study procedures.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
ability to communicate and comply with all study requirements
Description

Able to communicate | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C2364293
UMLS CUI [2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
o uncontrolled hypertension defined as seated blood pressure of either systolic bp >180 mmhg and/or diastolic bp >110mmhg.
Description

Uncontrolled hypertension | Sitting diastolic blood pressure | Sitting systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C1319894
UMLS CUI [3]
C1319893
clinically significant laboratory abnormalities that may interfere with the assessment of safety and/or efficacy of the study drug
Description

LABORATORY ABNORMALITIES Clinical Significance Interfere with Investigational New Drug Safety | LABORATORY ABNORMALITIES Clinical Significance Interfere with Investigational New Drug Efficacy

Data type

boolean

Alias
UMLS CUI [1,1]
C1853129
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0013230
UMLS CUI [1,5]
C0036043
UMLS CUI [2,1]
C1853129
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0013230
UMLS CUI [2,5]
C1280519
patients with severe medical condition(s) that in the view of the investigator may prohibit participation in the study
Description

medical condition Severe Study Subject Participation Status Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1272705
renal artery stenosis
Description

Renal Artery Stenosis

Data type

boolean

Alias
UMLS CUI [1]
C0035067
diabetes mellitus
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
any condition resulting from or leading to platelet or clotting abnormalities (eg. hemophilia, von willebrand's disease).
Description

Condition Due to Abnormal platelets | Condition Causing Abnormal platelets | Condition Due to abnormal clotting | Condition Causing abnormal clotting | Hemophilia | von Willebrand Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0151854
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0151854
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0424562
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0678227
UMLS CUI [4,3]
C0424562
UMLS CUI [5]
C0684275
UMLS CUI [6]
C0042974
history of a vascular event or intervention (e.g. mi, ptca or cabg) within 6 months preceding the study.
Description

Event Vascular | Surgical and medical procedure Vascular | Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C1801960
UMLS CUI [2,1]
C1948041
UMLS CUI [2,2]
C1801960
UMLS CUI [3]
C0027051
UMLS CUI [4]
C2936173
UMLS CUI [5]
C0010055
history of clinically significant angina, lvh, transient ischemic attack, stroke, intermittent claudication, deep vein thrombosis (dvt), pulmonary embolism or peripheral vascular disease.
Description

Angina Pectoris Clinical Significance | Left Ventricular Hypertrophy | Transient Ischemic Attack | Cerebrovascular accident | Intermittent Claudication | Deep Vein Thrombosis | Pulmonary Embolism | Peripheral Vascular Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0149721
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0021775
UMLS CUI [6]
C0149871
UMLS CUI [7]
C0034065
UMLS CUI [8]
C0085096
uncontrolled atrial fibrillation (>100 b.p.m. at rest) or other conditions which may require anti-aggregant or anti-vitamin k therapies.
Description

ATRIAL FIBRILLATION UNCONTROLLED Requirement Platelet Aggregation Inhibitors | ATRIAL FIBRILLATION UNCONTROLLED Requirement Therapeutic procedure Against Vitamin K | Condition Requirement Platelet Aggregation Inhibitors | Condition Requirement Therapeutic procedure Against Vitamin K

Data type

boolean

Alias
UMLS CUI [1,1]
C0741284
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0032177
UMLS CUI [2,1]
C0741284
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C0521124
UMLS CUI [2,5]
C0042878
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0032177
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0087111
UMLS CUI [4,4]
C0521124
UMLS CUI [4,5]
C0042878
clinical evidence of congestive heart failure.
Description

Congestive heart failure Evidence Clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205210
evidence of second or third degree heart block or sick sinus syndrome.
Description

Second degree atrioventricular block Evidence | Complete atrioventricular block Evidence | Sick Sinus Syndrome Evidence

Data type

boolean

Alias
UMLS CUI [1,1]
C0264906
UMLS CUI [1,2]
C3887511
UMLS CUI [2,1]
C0151517
UMLS CUI [2,2]
C3887511
UMLS CUI [3,1]
C0037052
UMLS CUI [3,2]
C3887511
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Similar models

Eligibility Hypertension NCT00171756

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female, aged between 18 - 75 years of age inclusively.
boolean
C0001779 (UMLS CUI [1])
Hypertension, mild | Hypertension, moderate | Sitting diastolic blood pressure mean | Sitting systolic blood pressure mean | Pharmacotherapy Patient need for | Examination of blood pressure Quantity | Therapeutic procedure Patient need for | Diet education | Lifestyle education
Item
mild to moderate hypertension (msdbp >= 95 and >= 110 mmhg and / or mssbp >140mm hg) at visit 1, requiring pharmacological intervention. for newly diagnosed patients, hypertensive blood pressure values must be noted on at least two successive examinations prior to entry into the study. in addition, patients must require therapy despite having been following dietary & lifestyle advice for at least 3 months.
boolean
C3276943 (UMLS CUI [1])
C1969581 (UMLS CUI [2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C1319893 (UMLS CUI [4,1])
C0444504 (UMLS CUI [4,2])
C0013216 (UMLS CUI [5,1])
C0686904 (UMLS CUI [5,2])
C0476712 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0087111 (UMLS CUI [7,1])
C0686904 (UMLS CUI [7,2])
C0204932 (UMLS CUI [8])
C0730543 (UMLS CUI [9])
Informed Consent
Item
written informed consent to participate in the study, prior to any study procedures.
boolean
C0021430 (UMLS CUI [1])
Able to communicate | Protocol Compliance
Item
ability to communicate and comply with all study requirements
boolean
C2364293 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Uncontrolled hypertension | Sitting diastolic blood pressure | Sitting systolic blood pressure
Item
o uncontrolled hypertension defined as seated blood pressure of either systolic bp >180 mmhg and/or diastolic bp >110mmhg.
boolean
C1868885 (UMLS CUI [1])
C1319894 (UMLS CUI [2])
C1319893 (UMLS CUI [3])
LABORATORY ABNORMALITIES Clinical Significance Interfere with Investigational New Drug Safety | LABORATORY ABNORMALITIES Clinical Significance Interfere with Investigational New Drug Efficacy
Item
clinically significant laboratory abnormalities that may interfere with the assessment of safety and/or efficacy of the study drug
boolean
C1853129 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0036043 (UMLS CUI [1,5])
C1853129 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C1280519 (UMLS CUI [2,5])
medical condition Severe Study Subject Participation Status Unsuccessful
Item
patients with severe medical condition(s) that in the view of the investigator may prohibit participation in the study
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1272705 (UMLS CUI [1,4])
Renal Artery Stenosis
Item
renal artery stenosis
boolean
C0035067 (UMLS CUI [1])
Diabetes Mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Condition Due to Abnormal platelets | Condition Causing Abnormal platelets | Condition Due to abnormal clotting | Condition Causing abnormal clotting | Hemophilia | von Willebrand Disease
Item
any condition resulting from or leading to platelet or clotting abnormalities (eg. hemophilia, von willebrand's disease).
boolean
C0348080 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0151854 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0151854 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0424562 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C0424562 (UMLS CUI [4,3])
C0684275 (UMLS CUI [5])
C0042974 (UMLS CUI [6])
Event Vascular | Surgical and medical procedure Vascular | Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery
Item
history of a vascular event or intervention (e.g. mi, ptca or cabg) within 6 months preceding the study.
boolean
C0441471 (UMLS CUI [1,1])
C1801960 (UMLS CUI [1,2])
C1948041 (UMLS CUI [2,1])
C1801960 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C2936173 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
Angina Pectoris Clinical Significance | Left Ventricular Hypertrophy | Transient Ischemic Attack | Cerebrovascular accident | Intermittent Claudication | Deep Vein Thrombosis | Pulmonary Embolism | Peripheral Vascular Diseases
Item
history of clinically significant angina, lvh, transient ischemic attack, stroke, intermittent claudication, deep vein thrombosis (dvt), pulmonary embolism or peripheral vascular disease.
boolean
C0002962 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0149721 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0021775 (UMLS CUI [5])
C0149871 (UMLS CUI [6])
C0034065 (UMLS CUI [7])
C0085096 (UMLS CUI [8])
ATRIAL FIBRILLATION UNCONTROLLED Requirement Platelet Aggregation Inhibitors | ATRIAL FIBRILLATION UNCONTROLLED Requirement Therapeutic procedure Against Vitamin K | Condition Requirement Platelet Aggregation Inhibitors | Condition Requirement Therapeutic procedure Against Vitamin K
Item
uncontrolled atrial fibrillation (>100 b.p.m. at rest) or other conditions which may require anti-aggregant or anti-vitamin k therapies.
boolean
C0741284 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0032177 (UMLS CUI [1,3])
C0741284 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0521124 (UMLS CUI [2,4])
C0042878 (UMLS CUI [2,5])
C0348080 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0032177 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0087111 (UMLS CUI [4,3])
C0521124 (UMLS CUI [4,4])
C0042878 (UMLS CUI [4,5])
Congestive heart failure Evidence Clinical
Item
clinical evidence of congestive heart failure.
boolean
C0018802 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
Second degree atrioventricular block Evidence | Complete atrioventricular block Evidence | Sick Sinus Syndrome Evidence
Item
evidence of second or third degree heart block or sick sinus syndrome.
boolean
C0264906 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0151517 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0037052 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
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