ID

17658

Beschreibung

Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00170950

Link

https://clinicaltrials.gov/show/NCT00170950

Stichworte

Versionen (2)
  1. 27.09.16 27.09.16 -
  2. 27.09.16 27.09.16 -
Hochgeladen am

27. September 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Hypertension NCT00170950

Englisch

Eligibility Hypertension NCT00170950

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
at least 55 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
previously untreated or treated hypertension.
Beschreibung

hypertension untreated | Hypertensive disease Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0745134
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C1522326
for patients >= 60 years, evidence of at least one cv disease or target organ damage, or for patients 55-59 years evidence of at least two cv diseases or target organ damage from two different organ systems as defined in the protocol.
Beschreibung

Age | Cardiovascular Diseases Quantity Evidence of | Target Organ Damage | Target Organ Damage Related body system Different

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0332120
UMLS CUI [3,1]
C1521840
UMLS CUI [3,2]
C0178784
UMLS CUI [3,3]
C1883709
UMLS CUI [4,1]
C1521840
UMLS CUI [4,2]
C0178784
UMLS CUI [4,3]
C1883709
UMLS CUI [4,4]
C0439849
UMLS CUI [4,5]
C0460002
UMLS CUI [4,6]
C1705242
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
allergy to any of the drugs administered in this trial.
Beschreibung

Hypersensitivity Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
current angina pectoris (ie, no anginal event requiring ntg within 1 month prior to visit 1).
Beschreibung

Angina Pectoris | Angina Pectoris Event Requirement Nitroglycerin

Datentyp

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0441471
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0017887
secondary hypertension.
Beschreibung

Secondary hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0155616
refractory hypertension defined as sbp >= 180 mmhg and/or dbp >= 110 mmhg unresponsive to triple-drug regimens of sympatholytics, diuretics and vasodilators.
Beschreibung

Refractory hypertension | Systolic Pressure | Diastolic blood pressure | Unresponsive to Treatment | Sympatholytics | Diuretics | Vasodilator Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0860493
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4]
C0205269
UMLS CUI [5]
C0039051
UMLS CUI [6]
C0012798
UMLS CUI [7]
C0042402
history of symptomatic heart failure (nyha classes ii-iv) or ejection fraction < 40%.
Beschreibung

Heart failure Symptomatic | New York Heart Association Classification | Cardiac ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C1275491
UMLS CUI [3]
C0232174
myocardial infarction, coronary revascularization (cabg or pci), unstable angina within one month of visit 1.
Beschreibung

Myocardial Infarction | Coronary revascularisation | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Angina, Unstable

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0877341
UMLS CUI [3]
C0010055
UMLS CUI [4]
C1532338
UMLS CUI [5]
C0002965
stroke or transient ischemic event (tia) within 3 months of visit 1.
Beschreibung

Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
significant obstructive valvular cardiovascular disease or any valvular disease expected to lead to surgery during the course of the study.
Beschreibung

disease; valve, valvular (obstructive) Significant | Cardiovascular Disease Significant | Valvular disease Resulting in Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1384985
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0750502
UMLS CUI [3,1]
C3258293
UMLS CUI [3,2]
C0332294
UMLS CUI [3,3]
C0543467
evidence of hepatic disease (ast or alt values >= 2 x upper limit of normal).
Beschreibung

Liver disease Evidence of | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
impaired renal function (serum creatinine >= 2.5 mg/dl (221 µmol/l)).
Beschreibung

Renal Insufficiency | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
baseline serum potassium of > 5.2 meq/l not on potassium supplements.
Beschreibung

Serum potassium measurement | Potassium supplement

Datentyp

boolean

Alias
UMLS CUI [1]
C0302353
UMLS CUI [2]
C0304475
history of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the last 5 years.
Beschreibung

Malignant Neoplasms | leukemia | Lymphoma | Basal cell carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0023418
UMLS CUI [3]
C0024299
UMLS CUI [4]
C0007117
history of clinically significant auto immune disorders such as systemic lupus erythematosus.
Beschreibung

Autoimmune Diseases Clinical Significance | Lupus Erythematosus, Systemic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0024141
significant non-cardiovascular illness or condition likely to result in death prior to trial completion, e.g., major organ transplant (life expectancy <5 years).
Beschreibung

Illness Significant Resulting in Cessation of life Probably | Organ Transplantation Major | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0332294
UMLS CUI [1,4]
C0011065
UMLS CUI [1,5]
C0750492
UMLS CUI [2,1]
C0029216
UMLS CUI [2,2]
C0205164
UMLS CUI [3]
C0023671
significant cardiovascular disease such as an aortic aneurysm ≥ 6 cm, likely requiring surgical intervention during the course of the study.
Beschreibung

Cardiovascular Disease Significant | Aortic Aneurysm Requirement Probably Operative Surgical Procedures

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0003486
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0750492
UMLS CUI [2,4]
C0543467
other protocol-defined exclusion criteria applied to the study.
Beschreibung

Exclusion Criteria Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563
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Ähnliche Modelle

Eligibility Hypertension NCT00170950

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
at least 55 years of age.
boolean
C0001779 (UMLS CUI [1])
hypertension untreated | Hypertensive disease Treated
Item
previously untreated or treated hypertension.
boolean
C0745134 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
Age | Cardiovascular Diseases Quantity Evidence of | Target Organ Damage | Target Organ Damage Related body system Different
Item
for patients >= 60 years, evidence of at least one cv disease or target organ damage, or for patients 55-59 years evidence of at least two cv diseases or target organ damage from two different organ systems as defined in the protocol.
boolean
C0001779 (UMLS CUI [1])
C0007222 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0332120 (UMLS CUI [2,3])
C1521840 (UMLS CUI [3,1])
C0178784 (UMLS CUI [3,2])
C1883709 (UMLS CUI [3,3])
C1521840 (UMLS CUI [4,1])
C0178784 (UMLS CUI [4,2])
C1883709 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
C0460002 (UMLS CUI [4,5])
C1705242 (UMLS CUI [4,6])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs
Item
allergy to any of the drugs administered in this trial.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Angina Pectoris | Angina Pectoris Event Requirement Nitroglycerin
Item
current angina pectoris (ie, no anginal event requiring ntg within 1 month prior to visit 1).
boolean
C0002962 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0441471 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0017887 (UMLS CUI [2,4])
Secondary hypertension
Item
secondary hypertension.
boolean
C0155616 (UMLS CUI [1])
Refractory hypertension | Systolic Pressure | Diastolic blood pressure | Unresponsive to Treatment | Sympatholytics | Diuretics | Vasodilator Agents
Item
refractory hypertension defined as sbp >= 180 mmhg and/or dbp >= 110 mmhg unresponsive to triple-drug regimens of sympatholytics, diuretics and vasodilators.
boolean
C0860493 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0205269 (UMLS CUI [4])
C0039051 (UMLS CUI [5])
C0012798 (UMLS CUI [6])
C0042402 (UMLS CUI [7])
Heart failure Symptomatic | New York Heart Association Classification | Cardiac ejection fraction
Item
history of symptomatic heart failure (nyha classes ii-iv) or ejection fraction < 40%.
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1275491 (UMLS CUI [2])
C0232174 (UMLS CUI [3])
Myocardial Infarction | Coronary revascularisation | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Angina, Unstable
Item
myocardial infarction, coronary revascularization (cabg or pci), unstable angina within one month of visit 1.
boolean
C0027051 (UMLS CUI [1])
C0877341 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C1532338 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
Cerebrovascular accident | Transient Ischemic Attack
Item
stroke or transient ischemic event (tia) within 3 months of visit 1.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
disease; valve, valvular (obstructive) Significant | Cardiovascular Disease Significant | Valvular disease Resulting in Operative Surgical Procedures
Item
significant obstructive valvular cardiovascular disease or any valvular disease expected to lead to surgery during the course of the study.
boolean
C1384985 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C3258293 (UMLS CUI [3,1])
C0332294 (UMLS CUI [3,2])
C0543467 (UMLS CUI [3,3])
Liver disease Evidence of | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
evidence of hepatic disease (ast or alt values >= 2 x upper limit of normal).
boolean
C0023895 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum
Item
impaired renal function (serum creatinine >= 2.5 mg/dl (221 µmol/l)).
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Serum potassium measurement | Potassium supplement
Item
baseline serum potassium of > 5.2 meq/l not on potassium supplements.
boolean
C0302353 (UMLS CUI [1])
C0304475 (UMLS CUI [2])
Malignant Neoplasms | leukemia | Lymphoma | Basal cell carcinoma
Item
history of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the last 5 years.
boolean
C0006826 (UMLS CUI [1])
C0023418 (UMLS CUI [2])
C0024299 (UMLS CUI [3])
C0007117 (UMLS CUI [4])
Autoimmune Diseases Clinical Significance | Lupus Erythematosus, Systemic
Item
history of clinically significant auto immune disorders such as systemic lupus erythematosus.
boolean
C0004364 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0024141 (UMLS CUI [2])
Illness Significant Resulting in Cessation of life Probably | Organ Transplantation Major | Life Expectancy
Item
significant non-cardiovascular illness or condition likely to result in death prior to trial completion, e.g., major organ transplant (life expectancy <5 years).
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332294 (UMLS CUI [1,3])
C0011065 (UMLS CUI [1,4])
C0750492 (UMLS CUI [1,5])
C0029216 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
Cardiovascular Disease Significant | Aortic Aneurysm Requirement Probably Operative Surgical Procedures
Item
significant cardiovascular disease such as an aortic aneurysm ≥ 6 cm, likely requiring surgical intervention during the course of the study.
boolean
C0007222 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0003486 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0750492 (UMLS CUI [2,3])
C0543467 (UMLS CUI [2,4])
Exclusion Criteria Study Protocol
Item
other protocol-defined exclusion criteria applied to the study.
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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