ID

40838

Description

Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00926289

Link

https://clinicaltrials.gov/show/NCT00926289

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 NCT00926289

English

Eligibility Hypertension NCT00926289

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. ability to provide written informed consent in accordance with good clinical practice and local legislation;
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. age 18 years or older;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. patients with grade 2 or grade 3 hypertension as defined sbp>=160 mmhg and dbp>=100 mmhg at randomization
Description

Hypertensive disease Grade | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0441800
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
4. ability to stop any current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
Description

Ability Antihypertensive therapy Discontinue | Absence Patient Risk

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0585941
UMLS CUI [1,3]
C1444662
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0030705
UMLS CUI [2,3]
C0035647
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who: a) are not surgically sterile; or b) are nursing, or c) are pregnant, or d) are of childbearing potential and are not practicing acceptable methods of birth control, or do not plan to continue practicing an acceptable method throughout the trial. the only acceptable methods of birth control are: intra-uterine device (iud), oral contraceptives, implantable or injectable contraceptives, estrogen patch hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study.
Description

Premenopausal state | Female Sterilization Absent | Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent | Intrauterine Devices | Contraceptives, Oral | Contraceptive implant | Contraceptive injection | Patch estrogen | Hormonal contraception

Data type

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2,1]
C0015787
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0032961
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0700589
UMLS CUI [5,3]
C0332197
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0009905
UMLS CUI [8]
C1657106
UMLS CUI [9]
C1656586
UMLS CUI [10]
C3843379
UMLS CUI [11]
C2985296
2. night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
Description

Night shift worker

Data type

boolean

Alias
UMLS CUI [1]
C0555008
3. known or suspected secondary hypertension (e.g., renal artery stenosis orphaeochromocytoma)
Description

Secondary hypertension | Secondary hypertension Suspected | Renal Artery Stenosis | Pheochromocytoma

Data type

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0155616
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0035067
UMLS CUI [4]
C0031511
4. mean in-clinic seated cuff sbp>= 200 mmhg and/or dbp >=120 mmhg
Description

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
5. renal dysfunction as defined by the following laboratory parameters: serum creatinine >3.0 mg/dl (or >265 umol/l) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.
Description

Renal dysfunction | Creatinine measurement, serum | Creatinine clearance measurement | Renal Insufficiency Severe

Data type

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
UMLS CUI [4,1]
C1565489
UMLS CUI [4,2]
C0205082
6. bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney
Description

Bilateral renal artery stenosis | Renal Artery Stenosis Kidney solitary | Status post Kidney Transplantation | Patients Kidney solitary

Data type

boolean

Alias
UMLS CUI [1]
C0856760
UMLS CUI [2,1]
C0035067
UMLS CUI [2,2]
C0022646
UMLS CUI [2,3]
C0205171
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0022671
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0022646
UMLS CUI [4,3]
C0205171
7. clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 mmol/l or >5.5 mmol/l, may be rechecked for suspected error in result)
Description

Hypokalemia | Hyperkalemia | Potassium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0020621
UMLS CUI [2]
C0020461
UMLS CUI [3]
C0202194
8. uncorrected sodium or volume depletion
Description

Hyponatremia uncorrected | Hypovolemia uncorrected

Data type

boolean

Alias
UMLS CUI [1,1]
C0020625
UMLS CUI [1,2]
C4072785
UMLS CUI [2,1]
C0546884
UMLS CUI [2,2]
C4072785
9. primary aldosteronism.
Description

Conn Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C1384514
10. hereditary fructose intolerance
Description

Hereditary fructose intolerance

Data type

boolean

Alias
UMLS CUI [1]
C0016751
11. biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
Description

Obstruction of biliary tree | Cholestasis | Hepatic Insufficiency

Data type

boolean

Alias
UMLS CUI [1]
C0400979
UMLS CUI [2]
C0008370
UMLS CUI [3]
C1306571
12. congestive heart failure new york heart association functional class congestive heart failure iii-iv (refer to appendix 10.3)
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
13. contra-indication to a placebo run-in period (e.g., stroke with-in the past 6 months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past 3 months prior to start of run in period)
Description

Medical contraindication Placebo Run-in Period | Cerebrovascular accident | Myocardial Infarction | Cardiac Surgery procedures | Percutaneous Transluminal Coronary Angioplasty | Angina, Unstable | Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0032042
UMLS CUI [1,3]
C3274438
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0018821
UMLS CUI [5]
C2936173
UMLS CUI [6]
C0002965
UMLS CUI [7]
C0010055
14. clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
Description

Tachycardia, Ventricular | Atrial Fibrillation | Atrial Flutter | Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0042514
UMLS CUI [2]
C0004238
UMLS CUI [3]
C0004239
UMLS CUI [4]
C0003811
15. hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
Description

Hypertrophic Cardiomyopathy | Coronary Artery Disease Obstructive Severe | Aortic Valve Stenosis Hemodynamic Relevant | Mitral Valve Stenosis Hemodynamic Relevant

Data type

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0549186
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C0003507
UMLS CUI [3,2]
C0019010
UMLS CUI [3,3]
C2347946
UMLS CUI [4,1]
C0026269
UMLS CUI [4,2]
C0019010
UMLS CUI [4,3]
C2347946
16. patients whose diabetes has not been stable and controlled for at least the past 3 months as defined by an glycosylated hemoglobin >=10%
Description

Unstable diabetes mellitus | Diabetic - poor control | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0342302
UMLS CUI [2]
C0421258
UMLS CUI [3]
C0474680
17. patients who have previously experienced symptoms characteristic of angioedema during treatment with ace inhibitors or angiotensin-ii receptor antagonists
Description

Symptoms Angioedema | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0002994
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0521942
18. history of drug or alcohol dependency within 6 months prior to signing the informed consent form
Description

Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
19. concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
Description

Pharmaceutical Preparations Affecting Blood Pressure | Exception Study Protocol Medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005823
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2348563
UMLS CUI [2,3]
C0013227
20. any investigational drug therapy within 1 month of signing the informed consent
Description

Pharmacotherapy Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1517586
21. known hypersensitivity to any component of the trial drugs (telmisartan, hydrochlorothiazide, or placebo)
Description

Hypersensitivity Component Investigational New Drugs | Hypersensitivity Telmisartan | Hydrochlorothiazide allergy | Hypersensitivity Placebo

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0248719
UMLS CUI [3]
C0571898
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0032042
22. history of non-compliance or inability to comply with prescribed medications or protocol procedures (less than 80% or more than 120%, especially during run-in)
Description

Compliance behavior Lacking | Medication Compliance Unable | Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C3489773
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C1299582
23. any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication
Description

Other medical condition Preventing Completion of clinical trial | Other medical condition Preventing Administration Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C1533734
UMLS CUI [2,4]
C0013230
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Similar models

Eligibility Hypertension NCT00926289

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. ability to provide written informed consent in accordance with good clinical practice and local legislation;
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age 18 years or older;
boolean
C0001779 (UMLS CUI [1])
Hypertensive disease Grade | Systolic Pressure | Diastolic blood pressure
Item
3. patients with grade 2 or grade 3 hypertension as defined sbp>=160 mmhg and dbp>=100 mmhg at randomization
boolean
C0020538 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Ability Antihypertensive therapy Discontinue | Absence Patient Risk
Item
4. ability to stop any current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
boolean
C0085732 (UMLS CUI [1,1])
C0585941 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C0035647 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Premenopausal state | Female Sterilization Absent | Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent | Intrauterine Devices | Contraceptives, Oral | Contraceptive implant | Contraceptive injection | Patch estrogen | Hormonal contraception
Item
1. pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who: a) are not surgically sterile; or b) are nursing, or c) are pregnant, or d) are of childbearing potential and are not practicing acceptable methods of birth control, or do not plan to continue practicing an acceptable method throughout the trial. the only acceptable methods of birth control are: intra-uterine device (iud), oral contraceptives, implantable or injectable contraceptives, estrogen patch hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study.
boolean
C0232969 (UMLS CUI [1])
C0015787 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C3831118 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0021900 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C1657106 (UMLS CUI [8])
C1656586 (UMLS CUI [9])
C3843379 (UMLS CUI [10])
C2985296 (UMLS CUI [11])
Night shift worker
Item
2. night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
boolean
C0555008 (UMLS CUI [1])
Secondary hypertension | Secondary hypertension Suspected | Renal Artery Stenosis | Pheochromocytoma
Item
3. known or suspected secondary hypertension (e.g., renal artery stenosis orphaeochromocytoma)
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0035067 (UMLS CUI [3])
C0031511 (UMLS CUI [4])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
4. mean in-clinic seated cuff sbp>= 200 mmhg and/or dbp >=120 mmhg
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Renal dysfunction | Creatinine measurement, serum | Creatinine clearance measurement | Renal Insufficiency Severe
Item
5. renal dysfunction as defined by the following laboratory parameters: serum creatinine >3.0 mg/dl (or >265 umol/l) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.
boolean
C3279454 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C1565489 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Bilateral renal artery stenosis | Renal Artery Stenosis Kidney solitary | Status post Kidney Transplantation | Patients Kidney solitary
Item
6. bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney
boolean
C0856760 (UMLS CUI [1])
C0035067 (UMLS CUI [2,1])
C0022646 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0022671 (UMLS CUI [3,2])
C0030705 (UMLS CUI [4,1])
C0022646 (UMLS CUI [4,2])
C0205171 (UMLS CUI [4,3])
Hypokalemia | Hyperkalemia | Potassium measurement
Item
7. clinically relevant hypokalemia or hyperkalemia (i.e., <3.5 mmol/l or >5.5 mmol/l, may be rechecked for suspected error in result)
boolean
C0020621 (UMLS CUI [1])
C0020461 (UMLS CUI [2])
C0202194 (UMLS CUI [3])
Hyponatremia uncorrected | Hypovolemia uncorrected
Item
8. uncorrected sodium or volume depletion
boolean
C0020625 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
C0546884 (UMLS CUI [2,1])
C4072785 (UMLS CUI [2,2])
Conn Syndrome
Item
9. primary aldosteronism.
boolean
C1384514 (UMLS CUI [1])
Hereditary fructose intolerance
Item
10. hereditary fructose intolerance
boolean
C0016751 (UMLS CUI [1])
Obstruction of biliary tree | Cholestasis | Hepatic Insufficiency
Item
11. biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
boolean
C0400979 (UMLS CUI [1])
C0008370 (UMLS CUI [2])
C1306571 (UMLS CUI [3])
Congestive heart failure New York Heart Association Classification
Item
12. congestive heart failure new york heart association functional class congestive heart failure iii-iv (refer to appendix 10.3)
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Medical contraindication Placebo Run-in Period | Cerebrovascular accident | Myocardial Infarction | Cardiac Surgery procedures | Percutaneous Transluminal Coronary Angioplasty | Angina, Unstable | Coronary Artery Bypass Surgery
Item
13. contra-indication to a placebo run-in period (e.g., stroke with-in the past 6 months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past 3 months prior to start of run in period)
boolean
C1301624 (UMLS CUI [1,1])
C0032042 (UMLS CUI [1,2])
C3274438 (UMLS CUI [1,3])
C0038454 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0018821 (UMLS CUI [4])
C2936173 (UMLS CUI [5])
C0002965 (UMLS CUI [6])
C0010055 (UMLS CUI [7])
Tachycardia, Ventricular | Atrial Fibrillation | Atrial Flutter | Cardiac Arrhythmia
Item
14. clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
boolean
C0042514 (UMLS CUI [1])
C0004238 (UMLS CUI [2])
C0004239 (UMLS CUI [3])
C0003811 (UMLS CUI [4])
Hypertrophic Cardiomyopathy | Coronary Artery Disease Obstructive Severe | Aortic Valve Stenosis Hemodynamic Relevant | Mitral Valve Stenosis Hemodynamic Relevant
Item
15. hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
boolean
C0007194 (UMLS CUI [1])
C1956346 (UMLS CUI [2,1])
C0549186 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0003507 (UMLS CUI [3,1])
C0019010 (UMLS CUI [3,2])
C2347946 (UMLS CUI [3,3])
C0026269 (UMLS CUI [4,1])
C0019010 (UMLS CUI [4,2])
C2347946 (UMLS CUI [4,3])
Unstable diabetes mellitus | Diabetic - poor control | Hemoglobin A1c measurement
Item
16. patients whose diabetes has not been stable and controlled for at least the past 3 months as defined by an glycosylated hemoglobin >=10%
boolean
C0342302 (UMLS CUI [1])
C0421258 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
Symptoms Angioedema | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
17. patients who have previously experienced symptoms characteristic of angioedema during treatment with ace inhibitors or angiotensin-ii receptor antagonists
boolean
C1457887 (UMLS CUI [1,1])
C0002994 (UMLS CUI [1,2])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
Substance Dependence
Item
18. history of drug or alcohol dependency within 6 months prior to signing the informed consent form
boolean
C0038580 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Blood Pressure | Exception Study Protocol Medication
Item
19. concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
Pharmacotherapy Investigational
Item
20. any investigational drug therapy within 1 month of signing the informed consent
boolean
C0013216 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Hypersensitivity Component Investigational New Drugs | Hypersensitivity Telmisartan | Hydrochlorothiazide allergy | Hypersensitivity Placebo
Item
21. known hypersensitivity to any component of the trial drugs (telmisartan, hydrochlorothiazide, or placebo)
boolean
C0020517 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0248719 (UMLS CUI [2,2])
C0571898 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0032042 (UMLS CUI [4,2])
Compliance behavior Lacking | Medication Compliance Unable | Protocol Compliance Unable
Item
22. history of non-compliance or inability to comply with prescribed medications or protocol procedures (less than 80% or more than 120%, especially during run-in)
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C3489773 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Other medical condition Preventing Completion of clinical trial | Other medical condition Preventing Administration Investigational New Drugs
Item
23. any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C1533734 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
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