ID

39952

Beschreibung

TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch; ODM derived from: https://clinicaltrials.gov/show/NCT01134393

Link

https://clinicaltrials.gov/show/NCT01134393

Stichworte

Versionen (1)
  1. 05.03.20 05.03.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. März 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hypertension NCT01134393

Englisch

Eligibility Hypertension NCT01134393

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Informed Consent

Datentyp

boolean

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

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. patients with uncontrolled hypertension as defined sbp > 140 mmhg and sbp > 130 mmhg in patients with diabetes or renal impairment or dbp > 90 mmhg and dbp >80 mmhg in patients with diabetes or renal impairment after at least an 6 weeks of stable treatment with antihypertensive medication defined as treatment with the clinically recommended dose of a single raas blocking agent (angiotensin converting enzym inhibition, aii receptor blocker and direct renin inhibitor) at entering the trial. renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min
Beschreibung

Uncontrolled hypertension | Systolic Pressure | Diabetes Mellitus | Renal Insufficiency | Diastolic blood pressure | Antihypertensive therapy Stable | RAAS Inhibitor Single | Angiotensin-Converting Enzyme Inhibitor | Angiotensin II receptor antagonist | DIRECT RENIN INHIBITOR | Creatinine measurement, serum | Gender | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0011849
UMLS CUI [4]
C1565489
UMLS CUI [5]
C0428883
UMLS CUI [6,1]
C0585941
UMLS CUI [6,2]
C0205360
UMLS CUI [7,1]
C0086907
UMLS CUI [7,2]
C1999216
UMLS CUI [7,3]
C0205171
UMLS CUI [8]
C0003015
UMLS CUI [9]
C0521942
UMLS CUI [10]
C1950687
UMLS CUI [11]
C0201976
UMLS CUI [12]
C0079399
UMLS CUI [13]
C0373595
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
Beschreibung

Premenopausal state | Female Sterilization Absent | Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Unwilling | Transdermal patch as birth control method | Contraceptives, Oral | Contraceptive implant | Injectable contraception | Sexual Abstinence | Partner had vasectomy

Datentyp

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 [6,1]
C3831118
UMLS CUI [6,2]
C0032976
UMLS CUI [6,3]
C0558080
UMLS CUI [7]
C2135981
UMLS CUI [8]
C0009905
UMLS CUI [9]
C1657106
UMLS CUI [10]
C1262153
UMLS CUI [11]
C0036899
UMLS CUI [12]
C0420842
2. known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma).
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0155616
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0035067
UMLS CUI [4]
C0031511
3. mean in-clinic seated cuff systolic bp >180 mmhg and sbp >160 mmhg in patients with diabetes or renal impairment or diastolic bp >110 mmhg and dbp >100 mmhg in patients with diabetes or renal impairment. renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min.
Beschreibung

Sitting systolic blood pressure mean | Systolic Pressure | Diabetes Mellitus | Renal Insufficiency | Diastolic blood pressure | Creatinine measurement, serum | Gender | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0011849
UMLS CUI [4]
C1565489
UMLS CUI [5]
C0428883
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0079399
UMLS CUI [8]
C0373595
4. renal dysfunction as defined by the following laboratory parameters: serum creatinine >3.0 mg/dl (or >265 ¿mol/l) and/or known creatinine clearance of <30 ml/min and/or clinical markers of severe renal impairment.
Beschreibung

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

Datentyp

boolean

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

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

Datentyp

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
6. clinically relevant hypokalaemia or hyperkalaemia (i.e., <3.5 or >5.5 meq/l).
Beschreibung

Hypokalemia | Hyperkalemia | Potassium measurement

Datentyp

boolean

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

Hyponatremia | Hypovolemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0020625
UMLS CUI [2]
C0546884
8. primary aldosteronism.
Beschreibung

Primary aldosteronism

Datentyp

boolean

Alias
UMLS CUI [1]
C1384514
9. hereditary fructose intolerance.
Beschreibung

Hereditary fructose intolerance syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0016751
10. congestive heart failure new york heart association functional class congestive heart failure iii-iv (refer to appendix 10.1).
Beschreibung

Congestive heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
11. clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0042514
UMLS CUI [2]
C0004238
UMLS CUI [3]
C0004239
UMLS CUI [4]
C0003811
12. biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency (defined as elevated levels of >2x bilirubin or >2x transaminases values). (refer to appendix 10.3)
Beschreibung

Bile Duct Diseases Obstructive | Cholestasis | Hepatic Insufficiency | SERUM TOTAL BILIRUBIN ELEVATED | Transaminases increased

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005395
UMLS CUI [1,2]
C0549186
UMLS CUI [2]
C0008370
UMLS CUI [3]
C1306571
UMLS CUI [4]
C0595866
UMLS CUI [5]
C0438717
13. patients who have previously experienced symptoms characteristic of angioedema during treatment with ace inhibitors or angiotensin-ii receptor antagonists.
Beschreibung

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

Datentyp

boolean

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

Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038580
15. any investigational drug therapy within one month of signing the informed consent.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
16. known hypersensitivity to any component of the trial drugs (telmisartan or amlodipine).
Beschreibung

Hypersensitivity Component Investigational New Drug | Hypersensitivity Telmisartan | Amlodipine allergy

Datentyp

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]
C0570921
17. history of non-compliance or inability to comply with prescribed medications or protocol procedures.
Beschreibung

Medication Nonadherence | Protocol Compliance Unable

Datentyp

boolean

Alias
UMLS CUI [1]
C0746935
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
18. 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.
Beschreibung

Medical condition Preventing Completion of clinical trial | Medical condition Preventing Administration Investigational New Drugs

Datentyp

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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Ähnliche Modelle

Eligibility Hypertension NCT01134393

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Uncontrolled hypertension | Systolic Pressure | Diabetes Mellitus | Renal Insufficiency | Diastolic blood pressure | Antihypertensive therapy Stable | RAAS Inhibitor Single | Angiotensin-Converting Enzyme Inhibitor | Angiotensin II receptor antagonist | DIRECT RENIN INHIBITOR | Creatinine measurement, serum | Gender | Creatinine clearance measurement
Item
3. patients with uncontrolled hypertension as defined sbp > 140 mmhg and sbp > 130 mmhg in patients with diabetes or renal impairment or dbp > 90 mmhg and dbp >80 mmhg in patients with diabetes or renal impairment after at least an 6 weeks of stable treatment with antihypertensive medication defined as treatment with the clinically recommended dose of a single raas blocking agent (angiotensin converting enzym inhibition, aii receptor blocker and direct renin inhibitor) at entering the trial. renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C1565489 (UMLS CUI [4])
C0428883 (UMLS CUI [5])
C0585941 (UMLS CUI [6,1])
C0205360 (UMLS CUI [6,2])
C0086907 (UMLS CUI [7,1])
C1999216 (UMLS CUI [7,2])
C0205171 (UMLS CUI [7,3])
C0003015 (UMLS CUI [8])
C0521942 (UMLS CUI [9])
C1950687 (UMLS CUI [10])
C0201976 (UMLS CUI [11])
C0079399 (UMLS CUI [12])
C0373595 (UMLS CUI [13])
Item Group
C0680251 (UMLS CUI)
Premenopausal state | Female Sterilization Absent | Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Unwilling | Transdermal patch as birth control method | Contraceptives, Oral | Contraceptive implant | Injectable contraception | Sexual Abstinence | Partner had vasectomy
Item
1. pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
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])
C3831118 (UMLS CUI [6,1])
C0032976 (UMLS CUI [6,2])
C0558080 (UMLS CUI [6,3])
C2135981 (UMLS CUI [7])
C0009905 (UMLS CUI [8])
C1657106 (UMLS CUI [9])
C1262153 (UMLS CUI [10])
C0036899 (UMLS CUI [11])
C0420842 (UMLS CUI [12])
Secondary hypertension | Secondary hypertension Suspected | Renal Artery Stenosis | Pheochromocytoma
Item
2. known or suspected secondary hypertension (e.g., renal artery stenosis or 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 | Systolic Pressure | Diabetes Mellitus | Renal Insufficiency | Diastolic blood pressure | Creatinine measurement, serum | Gender | Creatinine clearance measurement
Item
3. mean in-clinic seated cuff systolic bp >180 mmhg and sbp >160 mmhg in patients with diabetes or renal impairment or diastolic bp >110 mmhg and dbp >100 mmhg in patients with diabetes or renal impairment. renal impairment is defined as a creatinine >133µmol/l (1.5mg/dl) in male patients and a creatinine >124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
C1565489 (UMLS CUI [4])
C0428883 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0079399 (UMLS CUI [7])
C0373595 (UMLS CUI [8])
Renal dysfunction | Creatinine measurement, serum | Creatinine clearance measurement | Renal Insufficiency Severe
Item
4. renal dysfunction as defined by the following laboratory parameters: serum creatinine >3.0 mg/dl (or >265 ¿mol/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
5. 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
6. clinically relevant hypokalaemia or hyperkalaemia (i.e., <3.5 or >5.5 meq/l).
boolean
C0020621 (UMLS CUI [1])
C0020461 (UMLS CUI [2])
C0202194 (UMLS CUI [3])
Hyponatremia | Hypovolemia
Item
7. uncorrected sodium or volume depletion.
boolean
C0020625 (UMLS CUI [1])
C0546884 (UMLS CUI [2])
Primary aldosteronism
Item
8. primary aldosteronism.
boolean
C1384514 (UMLS CUI [1])
Hereditary fructose intolerance syndrome
Item
9. hereditary fructose intolerance.
boolean
C0016751 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
10. congestive heart failure new york heart association functional class congestive heart failure iii-iv (refer to appendix 10.1).
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Tachycardia, Ventricular | Atrial Fibrillation | Atrial Flutter | Cardiac Arrhythmia
Item
11. 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])
Bile Duct Diseases Obstructive | Cholestasis | Hepatic Insufficiency | SERUM TOTAL BILIRUBIN ELEVATED | Transaminases increased
Item
12. biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency (defined as elevated levels of >2x bilirubin or >2x transaminases values). (refer to appendix 10.3)
boolean
C0005395 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0008370 (UMLS CUI [2])
C1306571 (UMLS CUI [3])
C0595866 (UMLS CUI [4])
C0438717 (UMLS CUI [5])
Symptoms Angioedema | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
13. 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
14. history of drug or alcohol dependency within six months prior to signing the informed consent form.
boolean
C0038580 (UMLS CUI [1])
Investigational New Drugs
Item
15. any investigational drug therapy within one month of signing the informed consent.
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Component Investigational New Drug | Hypersensitivity Telmisartan | Amlodipine allergy
Item
16. known hypersensitivity to any component of the trial drugs (telmisartan or amlodipine).
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])
C0570921 (UMLS CUI [3])
Medication Nonadherence | Protocol Compliance Unable
Item
17. history of non-compliance or inability to comply with prescribed medications or protocol procedures.
boolean
C0746935 (UMLS CUI [1])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Medical condition Preventing Completion of clinical trial | Medical condition Preventing Administration Investigational New Drugs
Item
18. 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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