ID

40018

Beskrivning

The Study of Novel Dual Renin Angiotensin Aldosterone System (RAAS) Blockade; Valsartan/Aliskiren in African American Patients With Hypertension and the Metabolic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT01432106

Länk

https://clinicaltrials.gov/show/NCT01432106

Nyckelord

Versioner (1)
  1. 2020-03-09 2020-03-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 mars 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypertension NCT01432106

Engelsk

Eligibility Hypertension NCT01432106

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. african american men or women 18 - 80 years of age.
Beskrivning

African American | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0001779
2. appropriate therapy for high blood pressure consisting of no more than 2 antihypertensives.
Beskrivning

Antihypertensive therapy | Antihypertensive Agents Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0585941
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C1265611
3. patients with at least one marker of metabolic syndrome as evidenced by:
Beskrivning

Marker Quantity Metabolic Syndrome

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008963
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0524620
hdl cholesterol < 35mg/dl (men); < 45 mg/dl (women)
Beskrivning

Serum HDL cholesterol measurement | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0428472
UMLS CUI [2]
C0079399
triglycerides > 200mg/dl
Beskrivning

Triglycerides measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202236
fasting glucose >100mg/dl
Beskrivning

Fasting blood glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0428568
waist circumference: men >40 inches (102cm); women > 35 (88cm)
Beskrivning

Waist Circumference | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0455829
UMLS CUI [2]
C0079399
4. recent copy of ekg.
Beskrivning

Copy EKG Recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1948062
UMLS CUI [1,2]
C0013798
UMLS CUI [1,3]
C0332185
5. women able to become pregnant must use reliable contraception (e.g. hormonal contraception and double-barrier methods) throughout this study and for one week after the end of this study. post-menopausal or surgically sterile women.
Beskrivning

Childbearing Potential Contraceptive methods | Hormonal contraception | Barrier Contraception Double | Postmenopausal state | Female Sterilization

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C2985296
UMLS CUI [3,1]
C0004764
UMLS CUI [3,2]
C0205173
UMLS CUI [4]
C0232970
UMLS CUI [5]
C0015787
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. uncontrolled hypertension.
Beskrivning

Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
2. organ transplant.
Beskrivning

Organ Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C0029216
3. hypersensitivity to any study medications
Beskrivning

Hypersensitivity Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
4. systolic pressure 170 or higher or diastolic pressure 110 or higher.
Beskrivning

Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
5. cardiovascular events within last 6 months stroke, heart attack, stent, or hospitalization for severe heart failure.
Beskrivning

Cardiovascular event | Cerebrovascular accident | Myocardial Infarction | Placement of stent | Hospitalization Heart failure Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C1320716
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0522776
UMLS CUI [5,1]
C0019993
UMLS CUI [5,2]
C0018801
UMLS CUI [5,3]
C0205082
6. serum potassium greater than 5.0
Beskrivning

Serum potassium measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0302353
7. heart block without a pacemaker, continuing arrhythmia or valvular heart disease.
Beskrivning

Heart Block Without Pacemaker | Cardiac Arrhythmia | Heart valve disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018794
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0810633
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0018824
8. blocked renal artery.
Beskrivning

Renal artery occlusion

Datatyp

boolean

Alias
UMLS CUI [1]
C0553718
9. patients with severe renal impairment (creatinine 1.7 mg/dl for women and 2.0 mg/dl for men and or estimated gfr <30 ml/min) a history of dialysis, nephritic syndrome, or reno-vascular hypertension.
Beskrivning

Renal Insufficiency Severe | Creatinine measurement, serum | Gender | Estimated Glomerular Filtration Rate | Dialysis | Nephritic syndrome | Hypertension, Renovascular

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
UMLS CUI [4]
C3811844
UMLS CUI [5]
C0011946
UMLS CUI [6]
C0268732
UMLS CUI [7]
C0020545
10. any condition that may alter medication absorption.
Beskrivning

Condition Changing Drug absorption

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0678745
11. any condition that may place patient at higher risk from participating in study or will jeopardize the evaluation of efficacy or safety.
Beskrivning

Condition Study Subject Participation Status High risk | Condition Evaluation At risk

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C4319571
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1261322
UMLS CUI [2,3]
C1444641
12. use of any investigational study medications within 30 days of enrollment
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
13. persons unwilling or unable to take regular medications or comply with study protocol.
Beskrivning

Medication Regular Unwilling | Medication Regular Unable | Protocol Compliance Unwilling | Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0205272
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C0558080
UMLS CUI [4,1]
C0525058
UMLS CUI [4,2]
C1299582
14. pregnant or nursing (lactating) women, or women of childbearing potential (defined as all women physiologically capable of becoming pregnant) who do not use reliable methods of contraception: surgical sterilization, bilateral tubal ligation, hormonal contraception, implantable and oral) and double barrier methods if accepted by local regulatory authority and ethics committee. reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Female Sterilization | Bilateral tubal ligation | Hormonal contraception | Contraceptive implant Hormonal | Contraceptives, Oral, Hormonal | Barrier Contraception Double

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
UMLS CUI [4]
C0015787
UMLS CUI [5]
C0589114
UMLS CUI [6]
C2985296
UMLS CUI [7,1]
C1657106
UMLS CUI [7,2]
C0458083
UMLS CUI [8]
C0009907
UMLS CUI [9,1]
C0004764
UMLS CUI [9,2]
C0205173
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Similar models

Eligibility Hypertension NCT01432106

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
African American | Age
Item
1. african american men or women 18 - 80 years of age.
boolean
C0085756 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Antihypertensive therapy | Antihypertensive Agents Quantity
Item
2. appropriate therapy for high blood pressure consisting of no more than 2 antihypertensives.
boolean
C0585941 (UMLS CUI [1])
C0003364 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Marker Quantity Metabolic Syndrome
Item
3. patients with at least one marker of metabolic syndrome as evidenced by:
boolean
C0008963 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0524620 (UMLS CUI [1,3])
Serum HDL cholesterol measurement | Gender
Item
hdl cholesterol < 35mg/dl (men); < 45 mg/dl (women)
boolean
C0428472 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Triglycerides measurement
Item
triglycerides > 200mg/dl
boolean
C0202236 (UMLS CUI [1])
Fasting blood glucose measurement
Item
fasting glucose >100mg/dl
boolean
C0428568 (UMLS CUI [1])
Waist Circumference | Gender
Item
waist circumference: men >40 inches (102cm); women > 35 (88cm)
boolean
C0455829 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Copy EKG Recent
Item
4. recent copy of ekg.
boolean
C1948062 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods | Hormonal contraception | Barrier Contraception Double | Postmenopausal state | Female Sterilization
Item
5. women able to become pregnant must use reliable contraception (e.g. hormonal contraception and double-barrier methods) throughout this study and for one week after the end of this study. post-menopausal or surgically sterile women.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C2985296 (UMLS CUI [2])
C0004764 (UMLS CUI [3,1])
C0205173 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4])
C0015787 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Uncontrolled hypertension
Item
1. uncontrolled hypertension.
boolean
C1868885 (UMLS CUI [1])
Organ Transplantation
Item
2. organ transplant.
boolean
C0029216 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs
Item
3. hypersensitivity to any study medications
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Systolic Pressure | Diastolic blood pressure
Item
4. systolic pressure 170 or higher or diastolic pressure 110 or higher.
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Cardiovascular event | Cerebrovascular accident | Myocardial Infarction | Placement of stent | Hospitalization Heart failure Severe
Item
5. cardiovascular events within last 6 months stroke, heart attack, stent, or hospitalization for severe heart failure.
boolean
C1320716 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0522776 (UMLS CUI [4])
C0019993 (UMLS CUI [5,1])
C0018801 (UMLS CUI [5,2])
C0205082 (UMLS CUI [5,3])
Serum potassium measurement
Item
6. serum potassium greater than 5.0
boolean
C0302353 (UMLS CUI [1])
Heart Block Without Pacemaker | Cardiac Arrhythmia | Heart valve disease
Item
7. heart block without a pacemaker, continuing arrhythmia or valvular heart disease.
boolean
C0018794 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0810633 (UMLS CUI [1,3])
C0003811 (UMLS CUI [2])
C0018824 (UMLS CUI [3])
Renal artery occlusion
Item
8. blocked renal artery.
boolean
C0553718 (UMLS CUI [1])
Renal Insufficiency Severe | Creatinine measurement, serum | Gender | Estimated Glomerular Filtration Rate | Dialysis | Nephritic syndrome | Hypertension, Renovascular
Item
9. patients with severe renal impairment (creatinine 1.7 mg/dl for women and 2.0 mg/dl for men and or estimated gfr <30 ml/min) a history of dialysis, nephritic syndrome, or reno-vascular hypertension.
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C3811844 (UMLS CUI [4])
C0011946 (UMLS CUI [5])
C0268732 (UMLS CUI [6])
C0020545 (UMLS CUI [7])
Condition Changing Drug absorption
Item
10. any condition that may alter medication absorption.
boolean
C0348080 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
Condition Study Subject Participation Status High risk | Condition Evaluation At risk
Item
11. any condition that may place patient at higher risk from participating in study or will jeopardize the evaluation of efficacy or safety.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C4319571 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
Investigational New Drugs
Item
12. use of any investigational study medications within 30 days of enrollment
boolean
C0013230 (UMLS CUI [1])
Medication Regular Unwilling | Medication Regular Unable | Protocol Compliance Unwilling | Protocol Compliance Unable
Item
13. persons unwilling or unable to take regular medications or comply with study protocol.
boolean
C0013227 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0525058 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
C0525058 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Female Sterilization | Bilateral tubal ligation | Hormonal contraception | Contraceptive implant Hormonal | Contraceptives, Oral, Hormonal | Barrier Contraception Double
Item
14. pregnant or nursing (lactating) women, or women of childbearing potential (defined as all women physiologically capable of becoming pregnant) who do not use reliable methods of contraception: surgical sterilization, bilateral tubal ligation, hormonal contraception, implantable and oral) and double barrier methods if accepted by local regulatory authority and ethics committee. reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0015787 (UMLS CUI [4])
C0589114 (UMLS CUI [5])
C2985296 (UMLS CUI [6])
C1657106 (UMLS CUI [7,1])
C0458083 (UMLS CUI [7,2])
C0009907 (UMLS CUI [8])
C0004764 (UMLS CUI [9,1])
C0205173 (UMLS CUI [9,2])
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