ID

21042

Beschreibung

Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Comparing Telmisartan vs Valsartan. Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00168779

Link

https://clinicaltrials.gov/show/NCT00168779

Stichworte

Versionen (1)
  1. 05.04.17 05.04.17 -
Hochgeladen am

5. April 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hypertension NCT00168779

Englisch

Eligibility Hypertension NCT00168779

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. ability to provide written informed consent.
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. ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
Beschreibung

Antihypertensive therapy Stop Ability | Patient Risk Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0585941
UMLS CUI [1,2]
C2746065
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0035647
UMLS CUI [2,3]
C0332197
4. seated cuff dbp of ? 95 mmhg at visit 2 (baseline)
Beschreibung

Sitting diastolic blood pressure Cuff

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0441107
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Premenopausal state

Datentyp

boolean

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

Female Sterilization Missing

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015787
UMLS CUI [1,2]
C1705492
2. are nursing or pregnant
Beschreibung

Breast Feeding | Pregnancy

Datentyp

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, do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in studies of > 3-months duration. acceptable methods of birth control include oral, implantable, transdermal, or injectable contraceptives, and intra-uterine device (iud).
Beschreibung

Childbearing Potential Contraceptive methods Inadequate | Pregnancy Tests Periodic Unwilling | Contraceptives, Oral | Contraceptive implant | Transdermal contraception | Injectable contraception | Intrauterine Devices

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C0032976
UMLS CUI [2,2]
C0332182
UMLS CUI [2,3]
C0558080
UMLS CUI [3]
C0009905
UMLS CUI [4]
C1657106
UMLS CUI [5]
C1168146
UMLS CUI [6]
C1262153
UMLS CUI [7]
C0021900
2. known or suspected secondary hypertension.
Beschreibung

Secondary hypertension | Secondary hypertension Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2,1]
C0155616
UMLS CUI [2,2]
C0750491
3. mean seated sbp >= 180 mmhg or mean seated dbp >= 120 mmhg during any clinic visit prior to randomization.
Beschreibung

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C1319894
UMLS CUI [2,2]
C0444504
4. hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Beschreibung

Liver Dysfunction Laboratory Results | Renal dysfunction Laboratory Results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C1254595
UMLS CUI [2,1]
C3279454
UMLS CUI [2,2]
C1254595
1. sgpt (alt) or sgot (ast) > 2 times the upper limit of normal range, or
Beschreibung

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
2. serum creatinine > 3.0 mg/dl or creatinine clearance < 0.6 ml/sec.
Beschreibung

Creatinine measurement, serum | Creatinine clearance measurement

Datentyp

boolean

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

Bilateral renal artery stenosis | Renal Artery Stenosis Kidney Singular | Renal Artery Stenosis Kidney Transplantation Status post | Renal Artery Stenosis Kidney Quantity

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]
C0035067
UMLS CUI [3,2]
C0022671
UMLS CUI [3,3]
C0231290
UMLS CUI [4,1]
C0035067
UMLS CUI [4,2]
C0022646
UMLS CUI [4,3]
C1265611
6. clinically relevant hypokalemia or hyperkalemia.
Beschreibung

Hypokalemia | Hyperkalemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0020621
UMLS CUI [2]
C0020461
7. uncorrected volume depletion.
Beschreibung

Hypovolemia uncorrected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0546884
UMLS CUI [1,2]
C4072785
8. uncorrected sodium depletion.
Beschreibung

Hyponatremia uncorrected

Datentyp

boolean

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

Primary aldosteronism

Datentyp

boolean

Alias
UMLS CUI [1]
C1719312
10. hereditary fructose intolerance.
Beschreibung

Hereditary fructose intolerance

Datentyp

boolean

Alias
UMLS CUI [1]
C0016751
11. biliary obstructive disorders, cholestatis or moderate to severe hepatic in sufficiency.
Beschreibung

Biliary Tract Diseases Obstructive | Cholestasis | Hepatic Insufficiency Moderate | Hepatic Insufficiency Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005424
UMLS CUI [1,2]
C0549186
UMLS CUI [2]
C0008370
UMLS CUI [3,1]
C1306571
UMLS CUI [3,2]
C0205081
UMLS CUI [4,1]
C1306571
UMLS CUI [4,2]
C0205082
12. patients who have previously experienced symptoms characteristic of angioedema during treatment with ace inhibitors or angiotensin ii receptor antagonists.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002994
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1521970
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0521942
13. history of drug or alcohol dependency within six months prior to start of run-in period.
Beschreibung

Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038580
14. chronic administration of any medications known to affect blood pressure, exc
Beschreibung

Pharmaceutical Preparations chronic Affecting Blood Pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0005823
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Ähnliche Modelle

Eligibility Hypertension NCT00168779

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.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Antihypertensive therapy Stop Ability | Patient Risk Absent
Item
3. ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
boolean
C0585941 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Sitting diastolic blood pressure Cuff
Item
4. seated cuff dbp of ? 95 mmhg at visit 2 (baseline)
boolean
C1319894 (UMLS CUI [1,1])
C0441107 (UMLS CUI [1,2])
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 Missing
Item
1. are not surgically sterile and/or
boolean
C0015787 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
Breast Feeding | Pregnancy
Item
2. are nursing or pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Inadequate | Pregnancy Tests Periodic Unwilling | Contraceptives, Oral | Contraceptive implant | Transdermal contraception | Injectable contraception | Intrauterine Devices
Item
3. are of child-bearing potential and are not practicing acceptable means of birth control, do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in studies of > 3-months duration. acceptable methods of birth control include oral, implantable, transdermal, or injectable contraceptives, and intra-uterine device (iud).
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0032976 (UMLS CUI [2,1])
C0332182 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0009905 (UMLS CUI [3])
C1657106 (UMLS CUI [4])
C1168146 (UMLS CUI [5])
C1262153 (UMLS CUI [6])
C0021900 (UMLS CUI [7])
Secondary hypertension | Secondary hypertension Suspected
Item
2. known or suspected secondary hypertension.
boolean
C0155616 (UMLS CUI [1])
C0155616 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
3. mean seated sbp >= 180 mmhg or mean seated dbp >= 120 mmhg during any clinic visit prior to randomization.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
Liver Dysfunction Laboratory Results | Renal dysfunction Laboratory Results
Item
4. hepatic and/or renal dysfunction as defined by the following laboratory parameters:
boolean
C0086565 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C3279454 (UMLS CUI [2,1])
C1254595 (UMLS CUI [2,2])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
1. sgpt (alt) or sgot (ast) > 2 times the upper limit of normal range, or
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Creatinine measurement, serum | Creatinine clearance measurement
Item
2. serum creatinine > 3.0 mg/dl or creatinine clearance < 0.6 ml/sec.
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Bilateral renal artery stenosis | Renal Artery Stenosis Kidney Singular | Renal Artery Stenosis Kidney Transplantation Status post | Renal Artery Stenosis Kidney Quantity
Item
5. bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney.
boolean
C0856760 (UMLS CUI [1])
C0035067 (UMLS CUI [2,1])
C0022646 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0035067 (UMLS CUI [3,1])
C0022671 (UMLS CUI [3,2])
C0231290 (UMLS CUI [3,3])
C0035067 (UMLS CUI [4,1])
C0022646 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Hypokalemia | Hyperkalemia
Item
6. clinically relevant hypokalemia or hyperkalemia.
boolean
C0020621 (UMLS CUI [1])
C0020461 (UMLS CUI [2])
Hypovolemia uncorrected
Item
7. uncorrected volume depletion.
boolean
C0546884 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
Hyponatremia uncorrected
Item
8. uncorrected sodium depletion.
boolean
C0020625 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
Primary aldosteronism
Item
9. primary aldosteronism.
boolean
C1719312 (UMLS CUI [1])
Hereditary fructose intolerance
Item
10. hereditary fructose intolerance.
boolean
C0016751 (UMLS CUI [1])
Biliary Tract Diseases Obstructive | Cholestasis | Hepatic Insufficiency Moderate | Hepatic Insufficiency Severe
Item
11. biliary obstructive disorders, cholestatis or moderate to severe hepatic in sufficiency.
boolean
C0005424 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0008370 (UMLS CUI [2])
C1306571 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C1306571 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Angioedema Symptoms Characteristic | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
12. patients who have previously experienced symptoms characteristic of angioedema during treatment with ace inhibitors or angiotensin ii receptor antagonists.
boolean
C0002994 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1521970 (UMLS CUI [1,3])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
Substance Dependence
Item
13. history of drug or alcohol dependency within six months prior to start of run-in period.
boolean
C0038580 (UMLS CUI [1])
Pharmaceutical Preparations chronic Affecting Blood Pressure
Item
14. chronic administration of any medications known to affect blood pressure, exc
boolean
C0013227 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0005823 (UMLS CUI [1,4])
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