ID

29990

Description

Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00877929

Link

https://clinicaltrials.gov/show/NCT00877929

Keywords

Versions (1)
  1. 5/3/18 5/3/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 3, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00877929

English

Eligibility Hypertension NCT00877929

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. hypertension defined as a mean in-clinic seated cuff systolic blood pressure >150 mmhg at visit 3 (randomisation visit)
Description

Hypertensive disease | Sitting systolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
2. diagnosis of type 2 diabetes mellitus
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
3. =18 years of age at the date of signing the informed consent
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
Description

Antihypertensive therapy Discontinue Ability | Absence Risk Unacceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C0585941
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C1883420
5. ability to provide written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pre-menopausal women (last menstruation <=1 year prior to start of run-in period) who:
Description

Premenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232969
1. are not surgically sterile; and/or
Description

Female Sterilization Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0015787
UMLS CUI [1,2]
C0332197
2. are nursing or pregnant, or
Description

Breast Feeding | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
3. are of child-bearing potential and are not practicing acceptable means of birth control or do not plan to continue practising an acceptable method throughout the study.
Description

Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
the only acceptable methods of birth control are:
Description

Contraceptive methods Acceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1879533
intrauterine device (iud);
Description

Intrauterine Devices

Data type

boolean

Alias
UMLS CUI [1]
C0021900
oral contraceptives (started at least three months prior to start of run-in period)
Description

Contraceptives, Oral

Data type

boolean

Alias
UMLS CUI [1]
C0009905
implantable or injectable contraceptives and
Description

Contraceptive implant | Injectable contraception

Data type

boolean

Alias
UMLS CUI [1]
C1657106
UMLS CUI [2]
C1262153
estrogen patch
Description

Patch estrogen

Data type

boolean

Alias
UMLS CUI [1]
C3843379
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, phaeochromocytoma)
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 seated systolic blood pressure (sbp) =180 mm hg and/or mean seated diastolic blood pressure (dbp) =110 mm hg during any visit of the screening and placebo run-in periods
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. patients with type 1 diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
6. renal dysfunction as defined by the following laboratory parameters: serum creatinine >3.0 mg/dl (or >265 µmol /l) or known creatinine clearance <30 ml/min 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
7. 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 Single

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
8. clinically relevant hypokalaemia or hyperkalaemia
Description

Hypokalemia | Hyperkalemia

Data type

boolean

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

Sodium uncorrected | Hypovolemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0037473
UMLS CUI [1,2]
C4072785
UMLS CUI [2]
C0546884
10. primary aldosteronism
Description

Conn Syndrome

Data type

boolean

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

Hereditary fructose intolerance

Data type

boolean

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

Biliary Tract Diseases Obstructive | Cholestasis | Hepatic Insufficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C0005424
UMLS CUI [1,2]
C0549186
UMLS CUI [2]
C0008370
UMLS CUI [3]
C1306571
13. congestive heart failure new york heart academy (nyha) functional class chf 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
14. contraindication to a placebo run-in period (e.g., stroke with-in the past six months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three 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
15. 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
16. 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 | Mitral Valve Stenosis

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]
C0003507
UMLS CUI [4]
C0026269
17. patients whose diabetes has not been stable and controlled for at least the past three months as defined by an hba1c >10%
Description

Diabetes Mellitus Unstable Uncontrolled | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205318
UMLS CUI [2]
C0474680
18. patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin converting enzyme (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
19. history of drug or alcohol dependency within six months prior to signing the informed consent form
Description

Substance Dependence

Data type

boolean

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

Pharmaceutical Preparations Affecting Blood Pressure | Exception Pharmaceutical Preparations Study Protocol

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]
C0013227
UMLS CUI [2,3]
C2348563
21. any investigational drug therapy within one month of signing the informed consent
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
22. known hypersensitivity to any component of the study drugs (telmisartan, amlodipine, or placebo)
Description

Hypersensitivity Investigational New Drugs Component | Telmisartan | Amlodipine | Placebo

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1705248
UMLS CUI [2]
C0248719
UMLS CUI [3]
C0051696
UMLS CUI [4]
C0032042
23. history of non-compliance or inability to comply with prescribed medications or protocol procedures
Description

Compliance behavior Absent | Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
24. any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine
Description

Other medical condition Preventing Completion of clinical trial | Other medical condition Preventing Administration Telmisartan | Other medical condition Preventing Administration Amlodipine

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]
C0248719
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C1533734
UMLS CUI [3,4]
C0051696
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Similar models

Eligibility Hypertension NCT00877929

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hypertensive disease | Sitting systolic blood pressure mean
Item
1. hypertension defined as a mean in-clinic seated cuff systolic blood pressure >150 mmhg at visit 3 (randomisation visit)
boolean
C0020538 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
2. diagnosis of type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Age
Item
3. =18 years of age at the date of signing the informed consent
boolean
C0001779 (UMLS CUI [1])
Antihypertensive therapy Discontinue Ability | Absence Risk Unacceptable
Item
4. ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
boolean
C0585941 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C1883420 (UMLS CUI [2,3])
Informed Consent
Item
5. ability to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Premenopausal state
Item
1. pre-menopausal women (last menstruation <=1 year prior to start of run-in period) who:
boolean
C0232969 (UMLS CUI [1])
Female Sterilization Absent
Item
1. are not surgically sterile; and/or
boolean
C0015787 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Breast Feeding | Pregnancy
Item
2. are nursing or pregnant, or
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Absent
Item
3. are of child-bearing potential and are not practicing acceptable means of birth control or do not plan to continue practising an acceptable method throughout the study.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Contraceptive methods Acceptable
Item
the only acceptable methods of birth control are:
boolean
C0700589 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
Intrauterine Devices
Item
intrauterine device (iud);
boolean
C0021900 (UMLS CUI [1])
Contraceptives, Oral
Item
oral contraceptives (started at least three months prior to start of run-in period)
boolean
C0009905 (UMLS CUI [1])
Contraceptive implant | Injectable contraception
Item
implantable or injectable contraceptives and
boolean
C1657106 (UMLS CUI [1])
C1262153 (UMLS CUI [2])
Patch estrogen
Item
estrogen patch
boolean
C3843379 (UMLS CUI [1])
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, phaeochromocytoma)
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 seated systolic blood pressure (sbp) =180 mm hg and/or mean seated diastolic blood pressure (dbp) =110 mm hg during any visit of the screening and placebo run-in periods
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent
Item
5. patients with type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Renal dysfunction | Creatinine measurement, serum | Creatinine clearance measurement | Renal Insufficiency Severe
Item
6. renal dysfunction as defined by the following laboratory parameters: serum creatinine >3.0 mg/dl (or >265 µmol /l) or known creatinine clearance <30 ml/min 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 Single
Item
7. 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
Item
8. clinically relevant hypokalaemia or hyperkalaemia
boolean
C0020621 (UMLS CUI [1])
C0020461 (UMLS CUI [2])
Sodium uncorrected | Hypovolemia
Item
9. uncorrected sodium or volume depletion
boolean
C0037473 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
C0546884 (UMLS CUI [2])
Conn Syndrome
Item
10. primary aldosteronism
boolean
C1384514 (UMLS CUI [1])
Hereditary fructose intolerance
Item
11. hereditary fructose intolerance
boolean
C0016751 (UMLS CUI [1])
Biliary Tract Diseases Obstructive | Cholestasis | Hepatic Insufficiency
Item
12. biliary obstructive disorders (e.g., cholestatis) or hepatic insufficiency
boolean
C0005424 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0008370 (UMLS CUI [2])
C1306571 (UMLS CUI [3])
Congestive heart failure New York Heart Association Classification
Item
13. congestive heart failure new york heart academy (nyha) functional class chf 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
14. contraindication to a placebo run-in period (e.g., stroke with-in the past six months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three 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
15. 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 | Mitral Valve Stenosis
Item
16. 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])
C0026269 (UMLS CUI [4])
Diabetes Mellitus Unstable Uncontrolled | Hemoglobin A1c measurement
Item
17. patients whose diabetes has not been stable and controlled for at least the past three months as defined by an hba1c >10%
boolean
C0011849 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0474680 (UMLS CUI [2])
Symptoms Angioedema | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
18. patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin converting enzyme (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
19. history of drug or alcohol dependency within six months prior to signing the informed consent form
boolean
C0038580 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Blood Pressure | Exception Pharmaceutical Preparations Study Protocol
Item
20. 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])
C0013227 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
Investigational New Drugs
Item
21. any investigational drug therapy within one month of signing the informed consent
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs Component | Telmisartan | Amlodipine | Placebo
Item
22. known hypersensitivity to any component of the study drugs (telmisartan, amlodipine, or placebo)
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0248719 (UMLS CUI [2])
C0051696 (UMLS CUI [3])
C0032042 (UMLS CUI [4])
Compliance behavior Absent | Protocol Compliance Unable
Item
23. history of non-compliance or inability to comply with prescribed medications or protocol procedures
boolean
C1321605 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Other medical condition Preventing Completion of clinical trial | Other medical condition Preventing Administration Telmisartan | Other medical condition Preventing Administration Amlodipine
Item
24. any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine
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])
C0248719 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C1533734 (UMLS CUI [3,3])
C0051696 (UMLS CUI [3,4])
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