ID

44189

Beschreibung

Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00446511

Link

https://clinicaltrials.gov/show/NCT00446511

Stichworte

Versionen (2)
  1. 26.04.18 26.04.18 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hypertension NCT00446511

Englisch

Eligibility Hypertension NCT00446511

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
successful completion of 12 weeks of double-blind treatment in core protocol cval489k2302.
Beschreibung

Therapeutic procedure Double-Blind Method Successful Completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013072
UMLS CUI [1,3]
C1272703
UMLS CUI [1,4]
C0205197
patients participating in study cval489k2302 who may have discontinued prematurely due to uncontrolled hypertension defined as mssbp > 20%, but < 25% above the 95th percentile for age, gender, and height after visit 5, qualifies a patient for entry into this extension study.
Beschreibung

Study Subject Participation Status Clinical Trial Discontinued | Uncontrolled hypertension | Sitting systolic blood pressure mean | Age | Gender | Body Height

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1444662
UMLS CUI [2]
C1868885
UMLS CUI [3,1]
C1319893
UMLS CUI [3,2]
C0444504
UMLS CUI [4]
C0001779
UMLS CUI [5]
C0079399
UMLS CUI [6]
C0005890
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
renal artery stenosis.
Beschreibung

Renal Artery Stenosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0035067
current diagnosis of heart failure (nyha class ii-iv).
Beschreibung

Heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
second or third degree heart block without a pacemaker.
Beschreibung

Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3,1]
C0030163
UMLS CUI [3,2]
C0332197
concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
Beschreibung

Cardiac Arrhythmia Life Threatening | ARRHYTHMIA SYMPTOMATIC

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0741212
clinically significant valvular heart disease.
Beschreibung

Heart valve disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018824
patient that demonstrates clinically significant ecg abnormalities other than those associated with left ventricular hypertrophy and av block controlled with a pacemaker.
Beschreibung

ECG abnormality | Exception Left Ventricular Hypertrophy | Atrioventricular Block Controlled by Artificial cardiac pacemaker

Datentyp

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0149721
UMLS CUI [3,1]
C0004245
UMLS CUI [3,2]
C0332298
UMLS CUI [3,3]
C0030163
previous solid organ transplantation except renal, liver or heart transplantation. renal, liver or heart transplant must have occurred at least 6 months prior to enrollment. patient must be on stable doses of immunosuppressive therapy for 3 months and deemed clinically stable by the investigator.
Beschreibung

Solid organ transplant | Exception Kidney Transplantation | Exception Transplantation of liver | Exception Heart Transplantation | Therapeutic immunosuppression Dosage Stable | Patient Stable status

Datentyp

boolean

Alias
UMLS CUI [1]
C0730400
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0022671
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023911
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0018823
UMLS CUI [5,1]
C0021079
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0205360
UMLS CUI [6,1]
C0030705
UMLS CUI [6,2]
C0205360
patients who experienced any adverse events considered serious and drug related in protocol cval489k2302.
Beschreibung

Serious Adverse Event | Adverse reaction to drug

Datentyp

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0041755
other protocol-defined inclusion/exclusion criteria applied to the study.
Beschreibung

Eligibility Criteria Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Ähnliche Modelle

Eligibility Hypertension NCT00446511

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Therapeutic procedure Double-Blind Method Successful Completed
Item
successful completion of 12 weeks of double-blind treatment in core protocol cval489k2302.
boolean
C0087111 (UMLS CUI [1,1])
C0013072 (UMLS CUI [1,2])
C1272703 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Study Subject Participation Status Clinical Trial Discontinued | Uncontrolled hypertension | Sitting systolic blood pressure mean | Age | Gender | Body Height
Item
patients participating in study cval489k2302 who may have discontinued prematurely due to uncontrolled hypertension defined as mssbp > 20%, but < 25% above the 95th percentile for age, gender, and height after visit 5, qualifies a patient for entry into this extension study.
boolean
C2348568 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C1868885 (UMLS CUI [2])
C1319893 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
C0005890 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Renal Artery Stenosis
Item
renal artery stenosis.
boolean
C0035067 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
current diagnosis of heart failure (nyha class ii-iv).
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent
Item
second or third degree heart block without a pacemaker.
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0030163 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Cardiac Arrhythmia Life Threatening | ARRHYTHMIA SYMPTOMATIC
Item
concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
boolean
C0003811 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0741212 (UMLS CUI [2])
Heart valve disease
Item
clinically significant valvular heart disease.
boolean
C0018824 (UMLS CUI [1])
ECG abnormality | Exception Left Ventricular Hypertrophy | Atrioventricular Block Controlled by Artificial cardiac pacemaker
Item
patient that demonstrates clinically significant ecg abnormalities other than those associated with left ventricular hypertrophy and av block controlled with a pacemaker.
boolean
C0522055 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0149721 (UMLS CUI [2,2])
C0004245 (UMLS CUI [3,1])
C0332298 (UMLS CUI [3,2])
C0030163 (UMLS CUI [3,3])
Solid organ transplant | Exception Kidney Transplantation | Exception Transplantation of liver | Exception Heart Transplantation | Therapeutic immunosuppression Dosage Stable | Patient Stable status
Item
previous solid organ transplantation except renal, liver or heart transplantation. renal, liver or heart transplant must have occurred at least 6 months prior to enrollment. patient must be on stable doses of immunosuppressive therapy for 3 months and deemed clinically stable by the investigator.
boolean
C0730400 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0022671 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0023911 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0018823 (UMLS CUI [4,2])
C0021079 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C0030705 (UMLS CUI [6,1])
C0205360 (UMLS CUI [6,2])
Serious Adverse Event | Adverse reaction to drug
Item
patients who experienced any adverse events considered serious and drug related in protocol cval489k2302.
boolean
C1519255 (UMLS CUI [1])
C0041755 (UMLS CUI [2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria applied to the study.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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