ID

44265

Beschrijving

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

Trefwoorden

Versies (2)
  1. 05-05-18 05-05-18 -
  2. 20-09-21 20-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

20 september 2021

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Hypertension NCT01431508

Engels

Eligibility Hypertension NCT01431508

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age Legal

Datatype

boolean

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

Medical Problem Absent | Exception Essential Hypertension

Datatype

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.
Beschrijving

Absence Medical Problem Affecting Blood Pressure

Datatype

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
Beschrijving

Essential Hypertension Mild | Essential Hypertension Moderate

Datatype

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*.
Beschrijving

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

Datatype

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)
Beschrijving

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

Datatype

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.
Beschrijving

Antihypertensive therapy | Therapeutic procedure Absent

Datatype

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.
Beschrijving

Diabetes Mellitus Stable

Datatype

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating females.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

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

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

Datatype

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).
Beschrijving

Renal Artery Stenosis | Aortic coarctation | Pheochromocytoma

Datatype

boolean

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

Malignant Hypertension

Datatype

boolean

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

Sitting systolic blood pressure

Datatype

boolean

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

Cerebrovascular accident Physiologic resolution Lacking | Transient Ischemic Attack Stage

Datatype

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.
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
angina pectoris.
Beschrijving

Angina Pectoris

Datatype

boolean

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

Cardiac Arrhythmia

Datatype

boolean

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

Syncope Unknown

Datatype

boolean

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

Syncope

Datatype

boolean

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

Valvular disease Obstructive

Datatype

boolean

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

Cardiomyopathy

Datatype

boolean

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

Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery

Datatype

boolean

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

Single functional kidney

Datatype

boolean

Alias
UMLS CUI [1]
C1504368
Terug naar het begin van de pagina

Similar models

Eligibility Hypertension NCT01431508

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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