ID

39973

Beschreibung

A Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Different Dosing Regimens of MK-8266 in Participants With Hypertension (MK-8266-008 AM1)(COMPLETED); ODM derived from: https://clinicaltrials.gov/show/NCT01244035

Link

https://clinicaltrials.gov/show/NCT01244035

Stichworte

Versionen (1)
  1. 06.03.20 06.03.20 -
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See clinicaltrials.gov

Hochgeladen am

6. März 2020

DOI

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Eligibility Hypertension NCT01244035

Englisch

Eligibility Hypertension NCT01244035

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant has essential hypertension who is in grade 1 or 2 hypertension according to the european society of hypertension (esh) as delineated in the european society of cardiology (esc) 2007 guidelines, i.e. systolic blood pressure values of 140-179 and diastolic blood pressure values of 90-109 on at least 3 occasions prior to the study.
Beschreibung

Essential Hypertension | Hypertensive disease Grade | Systolic Pressure Measurement Quantity | Diastolic blood pressure Measurement Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0441800
UMLS CUI [3,1]
C0871470
UMLS CUI [3,2]
C0242485
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0428883
UMLS CUI [4,2]
C0242485
UMLS CUI [4,3]
C1265611
otherwise healthy participants with grade 1 or 2 arterial hypertension who are treated with a single antihypertensive drug and meet the above blood pressure criteria may be enrolled at the discretion of the investigator
Beschreibung

Other medical condition Absent | Hypertensive disease Grade | Antihypertensive Agent Single | Blood Pressure Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0441800
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C0205171
UMLS CUI [4,1]
C0005823
UMLS CUI [4,2]
C0243161
UMLS CUI [4,3]
C1550543
participant is generally in good health with the exception of hypertension
Beschreibung

General health good | Exception Hypertensive disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0020538
participant is a nonsmoker and/or has not used nicotine or nicotine-containing products for 6 months
Beschreibung

Non-smoker | Use of Nicotine Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0028040
UMLS CUI [2,3]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant has a history of any illness that might confound the results of the study or pose and additional risk to the participant if they take part in the study
Beschreibung

Illness Interferes with Research results | Illness Study Subject Participation Status At risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
participant has a history of stroke, chronic seizures, or major neurological disorder
Beschreibung

Cerebrovascular accident | Seizures chronic | Nervous system disorder Major

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2,1]
C0036572
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0205164
participant has a disability that can interfere with rising from a semi-recumbent position to the standing position
Beschreibung

Disability Interferes with Rising to standing position

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231170
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0444796
participant has a personal or family history of a bleeding or clotting disorder
Beschreibung

Blood Coagulation Disorder | Family history of blood coagulation disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C4038833
participant has a history of frequent nosebleeds or recurrent or active gingivitis
Beschreibung

Frequent nosebleeds | Gingivitis Recurrent | Gingivitis

Datentyp

boolean

Alias
UMLS CUI [1]
C4531300
UMLS CUI [2,1]
C0017574
UMLS CUI [2,2]
C2945760
UMLS CUI [3]
C0017574
participant has a history of cancer, except 1) certain skin cancers; 2) cancer successfully treated more than 10 years prior to the study that has not recurred; or, 3) participants who are unlikely to have a recurrence during the study
Beschreibung

Malignant Neoplasms | Exception Skin carcinoma Some | Exception Malignant Neoplasm Treated Successful | Exception Recurrence Absent | Exception Recurrence Unlikely

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C0205392
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0006826
UMLS CUI [3,3]
C1522326
UMLS CUI [3,4]
C1272703
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0034897
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0034897
UMLS CUI [5,3]
C0750558
participant has a history of cardiac disease including but not limited to heart valve disease or evidence of secondary cardiac damage
Beschreibung

Heart Disease | Heart valve disease | Heart Injury Secondary

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0018824
UMLS CUI [3,1]
C0018805
UMLS CUI [3,2]
C0175668
participant is categorized as class ii or greater according to the new york heart association (nyha) functional classification for heart failure
Beschreibung

Heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
participant is unable to refrain from use of prescription or non-prescription drugs or herbal remedies (such as st. john's wort) during the study
Beschreibung

Prescription Drugs Discontinue Unable | Non-Prescription Drugs Discontinue Unable | Herbal medicine Discontinue Unable | ST. JOHN'S WORT EXTRACT Discontinue Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304227
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C2240391
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0813171
UMLS CUI [4,2]
C1444662
UMLS CUI [4,3]
C1299582
participant anticipates using phosphodiesterase (pde5) inhibitors [sildenafil (viagra®), tadalafil (cialis®), or vardenafil (levitra®)] during the study
Beschreibung

Phosphodiesterase 5 inhibitor | sildenafil | Viagra | tadalafil | Cialis | vardenafil | Levitra

Datentyp

boolean

Alias
UMLS CUI [1]
C1318700
UMLS CUI [2]
C0529793
UMLS CUI [3]
C0663448
UMLS CUI [4]
C1176316
UMLS CUI [5]
C0967376
UMLS CUI [6]
C0971579
UMLS CUI [7]
C1174890
participant consumes excessive amounts of alcohol (more than 3 drinks per day) or caffeine (more than 6 servings a day)
Beschreibung

Alcohol intake above recommended sensible limits Alcoholic drinks U/day | Excessive caffeine intake Serving U/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0560219
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C3714418
UMLS CUI [2,2]
C1519269
UMLS CUI [2,3]
C0456683
participant has had major surgery, donated or lost 1 unit of blood, or participated in another investigational within 4 weeks prior to the study
Beschreibung

Major surgery | Blood Donation Unit Quantity | Blood Loss Unit Quantity | Study Subject Participation Status | Research study

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C0439184
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C3163616
UMLS CUI [3,2]
C0439184
UMLS CUI [3,3]
C1265611
UMLS CUI [4]
C2348568
UMLS CUI [5]
C0681814
participant has a history of multiple and/or severe allergies, or has had an anaphylactic reaction or intolerance to any drugs or food
Beschreibung

History of multiple allergies | Severe allergy | Drug-induced anaphylactoid reaction | Food anaphylaxis | Drug intolerance | Food intolerance

Datentyp

boolean

Alias
UMLS CUI [1]
C0455609
UMLS CUI [2]
C2945656
UMLS CUI [3]
C0344178
UMLS CUI [4]
C0685898
UMLS CUI [5]
C0277585
UMLS CUI [6]
C0149696
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Ähnliche Modelle

Eligibility Hypertension NCT01244035

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension | Hypertensive disease Grade | Systolic Pressure Measurement Quantity | Diastolic blood pressure Measurement Quantity
Item
participant has essential hypertension who is in grade 1 or 2 hypertension according to the european society of hypertension (esh) as delineated in the european society of cardiology (esc) 2007 guidelines, i.e. systolic blood pressure values of 140-179 and diastolic blood pressure values of 90-109 on at least 3 occasions prior to the study.
boolean
C0085580 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3,1])
C0242485 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0428883 (UMLS CUI [4,1])
C0242485 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Other medical condition Absent | Hypertensive disease Grade | Antihypertensive Agent Single | Blood Pressure Criteria Fulfill
Item
otherwise healthy participants with grade 1 or 2 arterial hypertension who are treated with a single antihypertensive drug and meet the above blood pressure criteria may be enrolled at the discretion of the investigator
boolean
C3843040 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2,1])
C0441800 (UMLS CUI [2,2])
C0003364 (UMLS CUI [3,1])
C0205171 (UMLS CUI [3,2])
C0005823 (UMLS CUI [4,1])
C0243161 (UMLS CUI [4,2])
C1550543 (UMLS CUI [4,3])
General health good | Exception Hypertensive disease
Item
participant is generally in good health with the exception of hypertension
boolean
C1277245 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0020538 (UMLS CUI [2,2])
Non-smoker | Use of Nicotine Absent
Item
participant is a nonsmoker and/or has not used nicotine or nicotine-containing products for 6 months
boolean
C0337672 (UMLS CUI [1])
C1524063 (UMLS CUI [2,1])
C0028040 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Illness Interferes with Research results | Illness Study Subject Participation Status At risk
Item
participant has a history of any illness that might confound the results of the study or pose and additional risk to the participant if they take part in the study
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
Cerebrovascular accident | Seizures chronic | Nervous system disorder Major
Item
participant has a history of stroke, chronic seizures, or major neurological disorder
boolean
C0038454 (UMLS CUI [1])
C0036572 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
Disability Interferes with Rising to standing position
Item
participant has a disability that can interfere with rising from a semi-recumbent position to the standing position
boolean
C0231170 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0444796 (UMLS CUI [1,3])
Blood Coagulation Disorder | Family history of blood coagulation disorder
Item
participant has a personal or family history of a bleeding or clotting disorder
boolean
C0005779 (UMLS CUI [1])
C4038833 (UMLS CUI [2])
Frequent nosebleeds | Gingivitis Recurrent | Gingivitis
Item
participant has a history of frequent nosebleeds or recurrent or active gingivitis
boolean
C4531300 (UMLS CUI [1])
C0017574 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C0017574 (UMLS CUI [3])
Malignant Neoplasms | Exception Skin carcinoma Some | Exception Malignant Neoplasm Treated Successful | Exception Recurrence Absent | Exception Recurrence Unlikely
Item
participant has a history of cancer, except 1) certain skin cancers; 2) cancer successfully treated more than 10 years prior to the study that has not recurred; or, 3) participants who are unlikely to have a recurrence during the study
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C0205392 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1272703 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0034897 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0034897 (UMLS CUI [5,2])
C0750558 (UMLS CUI [5,3])
Heart Disease | Heart valve disease | Heart Injury Secondary
Item
participant has a history of cardiac disease including but not limited to heart valve disease or evidence of secondary cardiac damage
boolean
C0018799 (UMLS CUI [1])
C0018824 (UMLS CUI [2])
C0018805 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
Heart failure New York Heart Association Classification
Item
participant is categorized as class ii or greater according to the new york heart association (nyha) functional classification for heart failure
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Prescription Drugs Discontinue Unable | Non-Prescription Drugs Discontinue Unable | Herbal medicine Discontinue Unable | ST. JOHN'S WORT EXTRACT Discontinue Unable
Item
participant is unable to refrain from use of prescription or non-prescription drugs or herbal remedies (such as st. john's wort) during the study
boolean
C0304227 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0013231 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C2240391 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0813171 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C1299582 (UMLS CUI [4,3])
Phosphodiesterase 5 inhibitor | sildenafil | Viagra | tadalafil | Cialis | vardenafil | Levitra
Item
participant anticipates using phosphodiesterase (pde5) inhibitors [sildenafil (viagra®), tadalafil (cialis®), or vardenafil (levitra®)] during the study
boolean
C1318700 (UMLS CUI [1])
C0529793 (UMLS CUI [2])
C0663448 (UMLS CUI [3])
C1176316 (UMLS CUI [4])
C0967376 (UMLS CUI [5])
C0971579 (UMLS CUI [6])
C1174890 (UMLS CUI [7])
Alcohol intake above recommended sensible limits Alcoholic drinks U/day | Excessive caffeine intake Serving U/day
Item
participant consumes excessive amounts of alcohol (more than 3 drinks per day) or caffeine (more than 6 servings a day)
boolean
C0560219 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C3714418 (UMLS CUI [2,1])
C1519269 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
Major surgery | Blood Donation Unit Quantity | Blood Loss Unit Quantity | Study Subject Participation Status | Research study
Item
participant has had major surgery, donated or lost 1 unit of blood, or participated in another investigational within 4 weeks prior to the study
boolean
C0679637 (UMLS CUI [1])
C0005794 (UMLS CUI [2,1])
C0439184 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C3163616 (UMLS CUI [3,1])
C0439184 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C2348568 (UMLS CUI [4])
C0681814 (UMLS CUI [5])
History of multiple allergies | Severe allergy | Drug-induced anaphylactoid reaction | Food anaphylaxis | Drug intolerance | Food intolerance
Item
participant has a history of multiple and/or severe allergies, or has had an anaphylactic reaction or intolerance to any drugs or food
boolean
C0455609 (UMLS CUI [1])
C2945656 (UMLS CUI [2])
C0344178 (UMLS CUI [3])
C0685898 (UMLS CUI [4])
C0277585 (UMLS CUI [5])
C0149696 (UMLS CUI [6])
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