ID

44265

Beschreibung

A Study of Safety and Efficacy in MK-0954A Combination in Participants With Hypertension (MK-0954A-373 AM3); ODM derived from: https://clinicaltrials.gov/show/NCT01431508

Link

https://clinicaltrials.gov/show/NCT01431508

Stichworte

Versionen (2)
  1. 05.05.18 05.05.18 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Creative Commons BY 4.0
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Eligibility Hypertension NCT01431508

Englisch

Eligibility Hypertension NCT01431508

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant will have reached the legal age by the time of entrance into the run-in period.
Beschreibung

Age Legal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1301860
participant has no active medical problem, other than essential hypertension,
Beschreibung

Medical Problem Absent | Exception Essential Hypertension

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0085580
which might of itself or by this treatment significantly affect the participant's blood pressure.
Beschreibung

Absence Medical Problem Affecting Blood Pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1254481
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0005823
participants diagnosed with mild to moderate essential hypertension or
Beschreibung

Essential Hypertension Mild | Essential Hypertension Moderate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C2945599
UMLS CUI [2,1]
C0085580
UMLS CUI [2,2]
C0205081
hypertension accompanying with established cardiovascular (cv) and renal diseases who are receiving antihypertensive regimen (exclude diuretic), yet not attaining to treatment goal*.
Beschreibung

Hypertensive cardiovascular-renal disease | Antihypertensive therapy Cardiovascular Diseases | Antihypertensive therapy Kidney Diseases | Diuretics Excluded | Therapeutic goal failed

Datentyp

boolean

Alias
UMLS CUI [1]
C1442904
UMLS CUI [2,1]
C0585941
UMLS CUI [2,2]
C0007222
UMLS CUI [3,1]
C0585941
UMLS CUI [3,2]
C0022658
UMLS CUI [4,1]
C0012798
UMLS CUI [4,2]
C0332196
UMLS CUI [5,1]
C0679840
UMLS CUI [5,2]
C0231175
* note: for essential hypertension, the goal is to reduce the blood pressure to less than 140/90. for hypertension with established cv and renal diseases, the bp goal is < 130/80. (according to 2007 european society of hypertension (esh) - european society of cardiology (esc) guideline)
Beschreibung

Essential Hypertension Therapeutic goal Blood pressure measurement | Hypertensive cardiovascular-renal disease Therapeutic goal Blood pressure measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085580
UMLS CUI [1,2]
C0679840
UMLS CUI [1,3]
C0005824
UMLS CUI [2,1]
C1442904
UMLS CUI [2,2]
C0679840
UMLS CUI [2,3]
C0005824
participant is either receiving antihypertensive therapy or no treatment.
Beschreibung

Antihypertensive therapy | Therapeutic procedure Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0585941
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332197
participants with stable diabetes mellitus may enter the study.
Beschreibung

Diabetes Mellitus Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0205360
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating females.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
secondary hypertension of any etiology (such as unilateral or bilateral renal
Beschreibung

Secondary hypertension Etiology Any | Kidney Disease Unilateral | Kidney Disease Bilateral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0155616
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C1552551
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205092
UMLS CUI [3,1]
C0022658
UMLS CUI [3,2]
C0238767
disease, renal artery stenosis, coarctation of the aorta, pheochromocytoma).
Beschreibung

Renal Artery Stenosis | Aortic coarctation | Pheochromocytoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0035067
UMLS CUI [2]
C0003492
UMLS CUI [3]
C0031511
history of malignant hypertension.
Beschreibung

Malignant Hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0020540
sitting systolic blood pressure >210 mmhg at visit 1 (day 0).
Beschreibung

Sitting systolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C1319893
participants with unresolved cerebrovascular accident or transient ischemic attack in the acute stage at visit 1.
Beschreibung

Cerebrovascular accident Physiologic resolution Lacking | Transient Ischemic Attack Stage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C1514893
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C0007787
UMLS CUI [2,2]
C0699749
a clinically confirmed myocardial infarction within the recent 3 months.
Beschreibung

Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
angina pectoris.
Beschreibung

Angina Pectoris

Datentyp

boolean

Alias
UMLS CUI [1]
C0002962
clinically important cardiac arrhythmia.
Beschreibung

Cardiac Arrhythmia

Datentyp

boolean

Alias
UMLS CUI [1]
C0003811
history of unexplained syncope within the prior 2 years, or a known syncopal
Beschreibung

Syncope Unknown

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0039070
UMLS CUI [1,2]
C0439673
disorder.
Beschreibung

Syncope

Datentyp

boolean

Alias
UMLS CUI [1]
C0039070
presence of hemodynamically significant obstructive valvular disease of
Beschreibung

Valvular disease Obstructive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C0549186
cardiomyopathy.
Beschreibung

Cardiomyopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0878544
percutaneous coronary angioplasty or coronary artery bypass surgery within the prior 3 months of visit 1.
Beschreibung

Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C2936173
UMLS CUI [2]
C0010055
participant with a single functioning kidney.
Beschreibung

Single functional kidney

Datentyp

boolean

Alias
UMLS CUI [1]
C1504368
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Ähnliche Modelle

Eligibility Hypertension NCT01431508

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age Legal
Item
participant will have reached the legal age by the time of entrance into the run-in period.
boolean
C0001779 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
Medical Problem Absent | Exception Essential Hypertension
Item
participant has no active medical problem, other than essential hypertension,
boolean
C1254481 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0085580 (UMLS CUI [2,2])
Absence Medical Problem Affecting Blood Pressure
Item
which might of itself or by this treatment significantly affect the participant's blood pressure.
boolean
C0332197 (UMLS CUI [1,1])
C1254481 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0005823 (UMLS CUI [1,4])
Essential Hypertension Mild | Essential Hypertension Moderate
Item
participants diagnosed with mild to moderate essential hypertension or
boolean
C0085580 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0085580 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
Hypertensive cardiovascular-renal disease | Antihypertensive therapy Cardiovascular Diseases | Antihypertensive therapy Kidney Diseases | Diuretics Excluded | Therapeutic goal failed
Item
hypertension accompanying with established cardiovascular (cv) and renal diseases who are receiving antihypertensive regimen (exclude diuretic), yet not attaining to treatment goal*.
boolean
C1442904 (UMLS CUI [1])
C0585941 (UMLS CUI [2,1])
C0007222 (UMLS CUI [2,2])
C0585941 (UMLS CUI [3,1])
C0022658 (UMLS CUI [3,2])
C0012798 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0679840 (UMLS CUI [5,1])
C0231175 (UMLS CUI [5,2])
Essential Hypertension Therapeutic goal Blood pressure measurement | Hypertensive cardiovascular-renal disease Therapeutic goal Blood pressure measurement
Item
* note: for essential hypertension, the goal is to reduce the blood pressure to less than 140/90. for hypertension with established cv and renal diseases, the bp goal is < 130/80. (according to 2007 european society of hypertension (esh) - european society of cardiology (esc) guideline)
boolean
C0085580 (UMLS CUI [1,1])
C0679840 (UMLS CUI [1,2])
C0005824 (UMLS CUI [1,3])
C1442904 (UMLS CUI [2,1])
C0679840 (UMLS CUI [2,2])
C0005824 (UMLS CUI [2,3])
Antihypertensive therapy | Therapeutic procedure Absent
Item
participant is either receiving antihypertensive therapy or no treatment.
boolean
C0585941 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Diabetes Mellitus Stable
Item
participants with stable diabetes mellitus may enter the study.
boolean
C0011849 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or lactating females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Secondary hypertension Etiology Any | Kidney Disease Unilateral | Kidney Disease Bilateral
Item
secondary hypertension of any etiology (such as unilateral or bilateral renal
boolean
C0155616 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
C0022658 (UMLS CUI [2,1])
C0205092 (UMLS CUI [2,2])
C0022658 (UMLS CUI [3,1])
C0238767 (UMLS CUI [3,2])
Renal Artery Stenosis | Aortic coarctation | Pheochromocytoma
Item
disease, renal artery stenosis, coarctation of the aorta, pheochromocytoma).
boolean
C0035067 (UMLS CUI [1])
C0003492 (UMLS CUI [2])
C0031511 (UMLS CUI [3])
Malignant Hypertension
Item
history of malignant hypertension.
boolean
C0020540 (UMLS CUI [1])
Sitting systolic blood pressure
Item
sitting systolic blood pressure >210 mmhg at visit 1 (day 0).
boolean
C1319893 (UMLS CUI [1])
Cerebrovascular accident Physiologic resolution Lacking | Transient Ischemic Attack Stage
Item
participants with unresolved cerebrovascular accident or transient ischemic attack in the acute stage at visit 1.
boolean
C0038454 (UMLS CUI [1,1])
C1514893 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0007787 (UMLS CUI [2,1])
C0699749 (UMLS CUI [2,2])
Myocardial Infarction
Item
a clinically confirmed myocardial infarction within the recent 3 months.
boolean
C0027051 (UMLS CUI [1])
Angina Pectoris
Item
angina pectoris.
boolean
C0002962 (UMLS CUI [1])
Cardiac Arrhythmia
Item
clinically important cardiac arrhythmia.
boolean
C0003811 (UMLS CUI [1])
Syncope Unknown
Item
history of unexplained syncope within the prior 2 years, or a known syncopal
boolean
C0039070 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Syncope
Item
disorder.
boolean
C0039070 (UMLS CUI [1])
Valvular disease Obstructive
Item
presence of hemodynamically significant obstructive valvular disease of
boolean
C3258293 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
Cardiomyopathy
Item
cardiomyopathy.
boolean
C0878544 (UMLS CUI [1])
Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery
Item
percutaneous coronary angioplasty or coronary artery bypass surgery within the prior 3 months of visit 1.
boolean
C2936173 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
Single functional kidney
Item
participant with a single functioning kidney.
boolean
C1504368 (UMLS CUI [1])
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