ID

30083

Descripción

Oral 6R-BH4 for the Treatment of Isolated Systolic Hypertension and Endothelial Dysfunction; ODM derived from: https://clinicaltrials.gov/show/NCT00802893

Link

https://clinicaltrials.gov/show/NCT00802893

Palabras clave

Versiones (1)
  1. 9/5/18 9/5/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

9 de mayo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Isolated Systolic Hypertension NCT00802893

Inglés

Eligibility Isolated Systolic Hypertension NCT00802893

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
no change in prescribed antihypertension medications within the previous 30 days
Descripción

Antihypertensive Agents prescribed unchanged

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0278329
UMLS CUI [1,3]
C0442739
study staff able to visualize and measure the brachial artery diameter by high resolution vascular ultrasound required for fmd measurements
Descripción

Brachial artery Diameter Vascular Ultrasound High resolution | Requirement Flow-Mediated Vasodilation Measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0006087
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0948543
UMLS CUI [1,4]
C1719039
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C4085863
UMLS CUI [2,3]
C0242485
ish with the following mean seated bp: sbp > 145 and < 180 mmhg. diastolic blood pressure < 90mmhg
Descripción

Sitting blood pressure mean | Systolic Pressure | Diastolic blood pressure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0580946
UMLS CUI [1,2]
C0444504
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
has known hypersensitivity to 6rbh4 or its excipients
Descripción

Hypersensitivity Sapropterin | Hypersensitivity Sapropterin Excipient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0048897
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0048897
UMLS CUI [2,3]
C0015237
pregnant or breastfeeding at screening
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
use of any investigational product or investigational medical device within 30 days prior to screening
Descripción

Investigational New Drugs | Investigational Medical Device

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
current disease or condition that would interfere with study participation or safety such as the following: heart failure, atrial fibrillation, aortic valve disease, bleeding disorders, history of repeated syncope or vertigo, severe gerd, gi ulcer, symptomatic coronary or peripheral vascular disease, arrhythmia, serious neurologic disorders including seizures, organ transplant or organ failure
Descripción

Disease Interferes with Study Subject Participation Status | Condition Interferes with Study Subject Participation Status | Disease Interferes with Safety | Condition Interferes with Safety | Heart failure | Atrial Fibrillation | Aortic valve disorder | Blood Coagulation Disorders | Syncope Repeated | Vertigo Repeated | Gastroesophageal reflux disease Severe | Gastrointestinal ulcer | Vascular Disease Coronary Symptomatic | Peripheral Vascular Disease Symptomatic | Cardiac Arrhythmia | Nervous system disorder Serious | Seizures | Organ Transplantation | Organ failure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0036043
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0036043
UMLS CUI [5]
C0018801
UMLS CUI [6]
C0004238
UMLS CUI [7]
C1260873
UMLS CUI [8]
C0005779
UMLS CUI [9,1]
C0039070
UMLS CUI [9,2]
C0205341
UMLS CUI [10,1]
C0042571
UMLS CUI [10,2]
C0205341
UMLS CUI [11,1]
C0017168
UMLS CUI [11,2]
C0205082
UMLS CUI [12]
C0237938
UMLS CUI [13,1]
C0042373
UMLS CUI [13,2]
C1522318
UMLS CUI [13,3]
C0231220
UMLS CUI [14,1]
C0085096
UMLS CUI [14,2]
C0231220
UMLS CUI [15]
C0003811
UMLS CUI [16,1]
C0027765
UMLS CUI [16,2]
C0205404
UMLS CUI [17]
C0036572
UMLS CUI [18]
C0029216
UMLS CUI [19]
C0349410
hypertension secondary to other medical conditions
Descripción

Secondary hypertension | Other medical condition

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C3843040
any severe comorbid condition that would limit life expectancy to <6 months
Descripción

Comorbidity Severe | Life Expectancy Limited

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0023671
UMLS CUI [2,2]
C0439801
current use of any nicotine containing substances
Descripción

Substance Containing Nicotine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0439861
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0028040
history of drug or alcohol abuse
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
mi, stroke or surgery within 90 days before screening visit
Descripción

Myocardial Infarction | Cerebrovascular accident | Operative Surgical Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0543467
cabg within 6 months before the screening visit
Descripción

Coronary Artery Bypass Surgery

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0010055
serum creatinine >2.0mg/dl or ast, alt, ggt levels >2times upper limit of normal
Descripción

Creatinine measurement, serum | Aspartate aminotransferase increased | Alanine aminotransferase increased | GGT elevated

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0239702
concomitant treatment with: any drug known to inhibit folate metabolism, any phosphodiesterase-5 or -3 inhibitor
Descripción

Pharmaceutical Preparations Preventing Folic acid metabolism | Phosphodiesterase 5 inhibitor | Phosphodiesterase 3 Inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C1157079
UMLS CUI [2]
C1318700
UMLS CUI [3]
C2267032
previous treatment with any formulation of bh4
Descripción

Sapropterin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0048897
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Similar models

Eligibility Isolated Systolic Hypertension NCT00802893

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Antihypertensive Agents prescribed unchanged
Item
no change in prescribed antihypertension medications within the previous 30 days
boolean
C0003364 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Brachial artery Diameter Vascular Ultrasound High resolution | Requirement Flow-Mediated Vasodilation Measurement
Item
study staff able to visualize and measure the brachial artery diameter by high resolution vascular ultrasound required for fmd measurements
boolean
C0006087 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0948543 (UMLS CUI [1,3])
C1719039 (UMLS CUI [1,4])
C1514873 (UMLS CUI [2,1])
C4085863 (UMLS CUI [2,2])
C0242485 (UMLS CUI [2,3])
Sitting blood pressure mean | Systolic Pressure | Diastolic blood pressure
Item
ish with the following mean seated bp: sbp > 145 and < 180 mmhg. diastolic blood pressure < 90mmhg
boolean
C0580946 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Sapropterin | Hypersensitivity Sapropterin Excipient
Item
has known hypersensitivity to 6rbh4 or its excipients
boolean
C0020517 (UMLS CUI [1,1])
C0048897 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0048897 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding at screening
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs | Investigational Medical Device
Item
use of any investigational product or investigational medical device within 30 days prior to screening
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Disease Interferes with Study Subject Participation Status | Condition Interferes with Study Subject Participation Status | Disease Interferes with Safety | Condition Interferes with Safety | Heart failure | Atrial Fibrillation | Aortic valve disorder | Blood Coagulation Disorders | Syncope Repeated | Vertigo Repeated | Gastroesophageal reflux disease Severe | Gastrointestinal ulcer | Vascular Disease Coronary Symptomatic | Peripheral Vascular Disease Symptomatic | Cardiac Arrhythmia | Nervous system disorder Serious | Seizures | Organ Transplantation | Organ failure
Item
current disease or condition that would interfere with study participation or safety such as the following: heart failure, atrial fibrillation, aortic valve disease, bleeding disorders, history of repeated syncope or vertigo, severe gerd, gi ulcer, symptomatic coronary or peripheral vascular disease, arrhythmia, serious neurologic disorders including seizures, organ transplant or organ failure
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0036043 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0036043 (UMLS CUI [4,3])
C0018801 (UMLS CUI [5])
C0004238 (UMLS CUI [6])
C1260873 (UMLS CUI [7])
C0005779 (UMLS CUI [8])
C0039070 (UMLS CUI [9,1])
C0205341 (UMLS CUI [9,2])
C0042571 (UMLS CUI [10,1])
C0205341 (UMLS CUI [10,2])
C0017168 (UMLS CUI [11,1])
C0205082 (UMLS CUI [11,2])
C0237938 (UMLS CUI [12])
C0042373 (UMLS CUI [13,1])
C1522318 (UMLS CUI [13,2])
C0231220 (UMLS CUI [13,3])
C0085096 (UMLS CUI [14,1])
C0231220 (UMLS CUI [14,2])
C0003811 (UMLS CUI [15])
C0027765 (UMLS CUI [16,1])
C0205404 (UMLS CUI [16,2])
C0036572 (UMLS CUI [17])
C0029216 (UMLS CUI [18])
C0349410 (UMLS CUI [19])
Secondary hypertension | Other medical condition
Item
hypertension secondary to other medical conditions
boolean
C0155616 (UMLS CUI [1])
C3843040 (UMLS CUI [2])
Comorbidity Severe | Life Expectancy Limited
Item
any severe comorbid condition that would limit life expectancy to <6 months
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023671 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Substance Containing Nicotine
Item
current use of any nicotine containing substances
boolean
C0439861 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0028040 (UMLS CUI [1,3])
Substance Use Disorders
Item
history of drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Myocardial Infarction | Cerebrovascular accident | Operative Surgical Procedures
Item
mi, stroke or surgery within 90 days before screening visit
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Coronary Artery Bypass Surgery
Item
cabg within 6 months before the screening visit
boolean
C0010055 (UMLS CUI [1])
Creatinine measurement, serum | Aspartate aminotransferase increased | Alanine aminotransferase increased | GGT elevated
Item
serum creatinine >2.0mg/dl or ast, alt, ggt levels >2times upper limit of normal
boolean
C0201976 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0239702 (UMLS CUI [4])
Pharmaceutical Preparations Preventing Folic acid metabolism | Phosphodiesterase 5 inhibitor | Phosphodiesterase 3 Inhibitors
Item
concomitant treatment with: any drug known to inhibit folate metabolism, any phosphodiesterase-5 or -3 inhibitor
boolean
C0013227 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1157079 (UMLS CUI [1,3])
C1318700 (UMLS CUI [2])
C2267032 (UMLS CUI [3])
Sapropterin
Item
previous treatment with any formulation of bh4
boolean
C0048897 (UMLS CUI [1])
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