ID

21042

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT00168779

Keywords

versioni (1)
  1. 05/04/17 05/04/17 -
Caricato su

5 aprile 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Hypertension NCT00168779

Inglese

Eligibility Hypertension NCT00168779

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. ability to provide written informed consent.
Descrizione

Informed Consent

Tipo di dati

boolean

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

Age

Tipo di dati

boolean

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

Antihypertensive therapy Stop Ability | Patient Risk Absent

Tipo di dati

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)
Descrizione

Sitting diastolic blood pressure Cuff

Tipo di dati

boolean

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

Exclusion Criteria

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

Premenopausal state

Tipo di dati

boolean

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

Female Sterilization Missing

Tipo di dati

boolean

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

Breast Feeding | Pregnancy

Tipo di dati

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).
Descrizione

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

Tipo di dati

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.
Descrizione

Secondary hypertension | Secondary hypertension Suspected

Tipo di dati

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.
Descrizione

Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Tipo di dati

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:
Descrizione

Liver Dysfunction Laboratory Results | Renal dysfunction Laboratory Results

Tipo di dati

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
Descrizione

Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo di dati

boolean

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

Creatinine measurement, serum | Creatinine clearance measurement

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

Hypokalemia | Hyperkalemia

Tipo di dati

boolean

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

Hypovolemia uncorrected

Tipo di dati

boolean

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

Hyponatremia uncorrected

Tipo di dati

boolean

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

Primary aldosteronism

Tipo di dati

boolean

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

Hereditary fructose intolerance

Tipo di dati

boolean

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

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

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

Substance Dependence

Tipo di dati

boolean

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

Pharmaceutical Preparations chronic Affecting Blood Pressure

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0005823
Ritorna all'inizio della pagina

Similar models

Eligibility Hypertension NCT00168779

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial