ID

40839

Description

Phase 4 Study to Assess the Effect of Bisoprolol on Glycemic Level in Type II Diabetic Subjects With Suboptimal Blood Pressure Control; ODM derived from: https://clinicaltrials.gov/show/NCT01066039

Link

https://clinicaltrials.gov/show/NCT01066039

Keywords

Versions (1)
  1. 5/22/20 5/22/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 22, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01066039

English

Eligibility Hypertension NCT01066039

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age of 20 years or older and less than 80 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects with t2dm
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
subjects who have failed to achieve an appropriate bp level as a result of treatment with any antihypertensive drug other than beta blockers - that is, with bp inadequately controlled to greater than or equal to (>=) 130/80 mmhg. however, those who have used a beta blocker before 12 weeks can be enrolled
Description

Blood pressure result Appropriate failed | Antihypertensive therapy | Exception Adrenergic beta-1 Receptor Antagonists | Blood pressure inadequately controlled | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1,1]
C1271104
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0231175
UMLS CUI [2]
C0585941
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0304516
UMLS CUI [4]
C0919892
UMLS CUI [5]
C0005824
subjects who underwent stable anti-diabetic regimen during the 12 weeks prior to screening
Description

Diabetes Therapy Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C3274787
UMLS CUI [1,2]
C0205360
signed written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
ongoing insulin therapy
Description

Insulin regime

Data type

boolean

Alias
UMLS CUI [1]
C0557978
change in two hba1c levels measured at an interval of 4 weeks or longer for the previous 6 months is at least 1% (the last hba1c is measured within 4 weeks)
Description

Hemoglobin A1c measurement Change Percentage Timespan

Data type

boolean

Alias
UMLS CUI [1,1]
C0474680
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C0872291
secondary hypertension
Description

Secondary hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0155616
subjects with renal impairment (creatinine greater than 150 micromol per liter or 1.7 milligram per deciliter)
Description

Renal Insufficiency | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
cardiovascular disease (uncontrolled or symptomatic arrhythmia, unstable angina, sick sinus syndrome, second or third degree atrioventricular (av) block, bradycardia [less than 50 beats per minute], congestive heart failure, myocardial infarction, cerebral infraction attached within 12 weeks)
Description

Cardiovascular Disease | Cardiac Arrhythmia Uncontrolled | ARRHYTHMIA SYMPTOMATIC | Angina, Unstable | Sick Sinus Syndrome | Second degree atrioventricular block | Complete atrioventricular block | Bradycardia | Congestive heart failure | Myocardial Infarction | Cerebral Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0741212
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0037052
UMLS CUI [6]
C0264906
UMLS CUI [7]
C0151517
UMLS CUI [8]
C0428977
UMLS CUI [9]
C0018802
UMLS CUI [10]
C0027051
UMLS CUI [11]
C0007785
subjects requiring bp control by at least 3 different antihypertensive drugs, or with either systolic blood pressure (sbp) >=180 mmhg or diastolic blood pressure (dbp) >=110 mmhg at baseline
Description

Patient need for Blood Pressure Control | Blood Pressure Controlled by Antihypertensive Agents | Antihypertensive Agents Different Quantity | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0005823
UMLS CUI [1,3]
C2587213
UMLS CUI [2,1]
C0005823
UMLS CUI [2,2]
C0332298
UMLS CUI [2,3]
C0003364
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C1705242
UMLS CUI [3,3]
C1265611
UMLS CUI [4]
C0871470
UMLS CUI [5]
C0428883
subjects with type 1 diabetes mellitus (t1dm)
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
uncontrolled diabetes with hba1c >9%
Description

Diabetic - poor control | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C0474680
bmi >40 kilogram per square meter (kg/m^2)
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
pulmonary disease (chronic obstructive pulmonary disease [copd], bronchial asthma)
Description

Lung disease | Chronic Obstructive Airway Disease | Asthma

Data type

boolean

Alias
UMLS CUI [1]
C0024115
UMLS CUI [2]
C0024117
UMLS CUI [3]
C0004096
other patients considered by the investigator to be not eligible for participation in this study for a legal or mental reason
Description

Study Subject Participation Status | Ineligibility Legal Aspects | Ineligibility Due to Mental problem

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1512714
UMLS CUI [2,2]
C0220868
UMLS CUI [3,1]
C1512714
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0848067
contraindications for beta-blocker
Description

Medical contraindication Adrenergic beta-1 Receptor Antagonists

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0304516
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
use of an investigational drug within 30 days of entry to the study
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Hypertension NCT01066039

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age of 20 years or older and less than 80 years
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
subjects with t2dm
boolean
C0011860 (UMLS CUI [1])
Blood pressure result Appropriate failed | Antihypertensive therapy | Exception Adrenergic beta-1 Receptor Antagonists | Blood pressure inadequately controlled | Blood pressure determination
Item
subjects who have failed to achieve an appropriate bp level as a result of treatment with any antihypertensive drug other than beta blockers - that is, with bp inadequately controlled to greater than or equal to (>=) 130/80 mmhg. however, those who have used a beta blocker before 12 weeks can be enrolled
boolean
C1271104 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0585941 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0304516 (UMLS CUI [3,2])
C0919892 (UMLS CUI [4])
C0005824 (UMLS CUI [5])
Diabetes Therapy Stable
Item
subjects who underwent stable anti-diabetic regimen during the 12 weeks prior to screening
boolean
C3274787 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Insulin regime
Item
ongoing insulin therapy
boolean
C0557978 (UMLS CUI [1])
Hemoglobin A1c measurement Change Percentage Timespan
Item
change in two hba1c levels measured at an interval of 4 weeks or longer for the previous 6 months is at least 1% (the last hba1c is measured within 4 weeks)
boolean
C0474680 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0872291 (UMLS CUI [1,4])
Secondary hypertension
Item
secondary hypertension
boolean
C0155616 (UMLS CUI [1])
Renal Insufficiency | Creatinine measurement, serum
Item
subjects with renal impairment (creatinine greater than 150 micromol per liter or 1.7 milligram per deciliter)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Cardiovascular Disease | Cardiac Arrhythmia Uncontrolled | ARRHYTHMIA SYMPTOMATIC | Angina, Unstable | Sick Sinus Syndrome | Second degree atrioventricular block | Complete atrioventricular block | Bradycardia | Congestive heart failure | Myocardial Infarction | Cerebral Infarction
Item
cardiovascular disease (uncontrolled or symptomatic arrhythmia, unstable angina, sick sinus syndrome, second or third degree atrioventricular (av) block, bradycardia [less than 50 beats per minute], congestive heart failure, myocardial infarction, cerebral infraction attached within 12 weeks)
boolean
C0007222 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0741212 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0037052 (UMLS CUI [5])
C0264906 (UMLS CUI [6])
C0151517 (UMLS CUI [7])
C0428977 (UMLS CUI [8])
C0018802 (UMLS CUI [9])
C0027051 (UMLS CUI [10])
C0007785 (UMLS CUI [11])
Patient need for Blood Pressure Control | Blood Pressure Controlled by Antihypertensive Agents | Antihypertensive Agents Different Quantity | Systolic Pressure | Diastolic blood pressure
Item
subjects requiring bp control by at least 3 different antihypertensive drugs, or with either systolic blood pressure (sbp) >=180 mmhg or diastolic blood pressure (dbp) >=110 mmhg at baseline
boolean
C0686904 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
C2587213 (UMLS CUI [1,3])
C0005823 (UMLS CUI [2,1])
C0332298 (UMLS CUI [2,2])
C0003364 (UMLS CUI [2,3])
C0003364 (UMLS CUI [3,1])
C1705242 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0871470 (UMLS CUI [4])
C0428883 (UMLS CUI [5])
Diabetes Mellitus, Insulin-Dependent
Item
subjects with type 1 diabetes mellitus (t1dm)
boolean
C0011854 (UMLS CUI [1])
Diabetic - poor control | Hemoglobin A1c measurement
Item
uncontrolled diabetes with hba1c >9%
boolean
C0421258 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Body mass index
Item
bmi >40 kilogram per square meter (kg/m^2)
boolean
C1305855 (UMLS CUI [1])
Lung disease | Chronic Obstructive Airway Disease | Asthma
Item
pulmonary disease (chronic obstructive pulmonary disease [copd], bronchial asthma)
boolean
C0024115 (UMLS CUI [1])
C0024117 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
Study Subject Participation Status | Ineligibility Legal Aspects | Ineligibility Due to Mental problem
Item
other patients considered by the investigator to be not eligible for participation in this study for a legal or mental reason
boolean
C2348568 (UMLS CUI [1])
C1512714 (UMLS CUI [2,1])
C0220868 (UMLS CUI [2,2])
C1512714 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0848067 (UMLS CUI [3,3])
Medical contraindication Adrenergic beta-1 Receptor Antagonists
Item
contraindications for beta-blocker
boolean
C1301624 (UMLS CUI [1,1])
C0304516 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
use of an investigational drug within 30 days of entry to the study
boolean
C0013230 (UMLS CUI [1])
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