ID

39938

Beschreibung

The Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Participants and Participants With Hypertension (MK-0000-166) (COMPLETED); ODM derived from: https://clinicaltrials.gov/show/NCT01130168

Link

https://clinicaltrials.gov/show/NCT01130168

Stichworte

Versionen (1)
  1. 05.03.20 05.03.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. März 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hypertension NCT01130168

Englisch

Eligibility Hypertension NCT01130168

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant is a male or female between 30 and 65 years of age (inclusive) at the pre-study (screening)
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
female participant of childbearing potential must have a negative pregnancy test
Beschreibung

Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
participant has a brachial systolic blood pressure >130 mm hg
Beschreibung

Systolic Pressure Brachial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0445456
and <180 mm hg
Beschreibung

ID.4

Datentyp

boolean

participant has a body mass index (bmi) that is >20 kg/m^2 and <35 kg/m^2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
participant has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 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
female participant is pregnant or lactating
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participant anticipates the use of non-steroidal anti-inflammatory drugs (nsaids) other than acetaminophen
Beschreibung

Non-Steroidal Anti-Inflammatory Agents Anticipated | Exception Acetaminophen

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C3840775
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0000970
participant is currently a user (including "recreational use") of any illicit drugs, has a history of drug or alcohol abuse within approximately 2 years, or has a positive prestudy urine drug screen
Beschreibung

Illicit medication use | Substance Use Disorders | Urine drug screen positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0281875
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0743300
participant has a condition for which there is a warning, contraindication, or precaution against the use of ismn er including: acute myocardial infarction or congestive heart failure, hypotension, volume depletion, and pregnancy
Beschreibung

Medical contraindication ISMN ER | Myocardial Infarction | Congestive heart failure | Hypotension | Hypovolemia | Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0064079
UMLS CUI [1,3]
C1707968
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0020649
UMLS CUI [5]
C0546884
UMLS CUI [6]
C0032961
participant has a history of significant drug allergy or any clinically significant adverse experience of a serious nature related to the administration of either a marketed or an investigational drug, including nitrates, nitrites, amlodipine, and ismn er
Beschreibung

Drug Allergy | Adverse reaction to drug | Adverse reaction Investigational New Drugs | Adverse reaction Nitrates | Adverse reaction Nitrites | Amlodipine allergy | Adverse reaction ISMN ER

Datentyp

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2]
C0041755
UMLS CUI [3,1]
C0559546
UMLS CUI [3,2]
C0013230
UMLS CUI [4,1]
C0559546
UMLS CUI [4,2]
C0028125
UMLS CUI [5,1]
C0559546
UMLS CUI [5,2]
C0028137
UMLS CUI [6]
C0570921
UMLS CUI [7,1]
C0559546
UMLS CUI [7,2]
C0064079
UMLS CUI [7,3]
C1707968
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Ähnliche Modelle

Eligibility Hypertension NCT01130168

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
participant is a male or female between 30 and 65 years of age (inclusive) at the pre-study (screening)
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
female participant of childbearing potential must have a negative pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Systolic Pressure Brachial
Item
participant has a brachial systolic blood pressure >130 mm hg
boolean
C0871470 (UMLS CUI [1,1])
C0445456 (UMLS CUI [1,2])
ID.4
Item
and <180 mm hg
boolean
Body mass index
Item
participant has a body mass index (bmi) that is >20 kg/m^2 and <35 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Non-smoker | Use of Nicotine Absent
Item
participant has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 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)
Pregnancy | Breast Feeding
Item
female participant is pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Non-Steroidal Anti-Inflammatory Agents Anticipated | Exception Acetaminophen
Item
participant anticipates the use of non-steroidal anti-inflammatory drugs (nsaids) other than acetaminophen
boolean
C0003211 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0000970 (UMLS CUI [2,2])
Illicit medication use | Substance Use Disorders | Urine drug screen positive
Item
participant is currently a user (including "recreational use") of any illicit drugs, has a history of drug or alcohol abuse within approximately 2 years, or has a positive prestudy urine drug screen
boolean
C0281875 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C0743300 (UMLS CUI [3])
Medical contraindication ISMN ER | Myocardial Infarction | Congestive heart failure | Hypotension | Hypovolemia | Pregnancy
Item
participant has a condition for which there is a warning, contraindication, or precaution against the use of ismn er including: acute myocardial infarction or congestive heart failure, hypotension, volume depletion, and pregnancy
boolean
C1301624 (UMLS CUI [1,1])
C0064079 (UMLS CUI [1,2])
C1707968 (UMLS CUI [1,3])
C0027051 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0020649 (UMLS CUI [4])
C0546884 (UMLS CUI [5])
C0032961 (UMLS CUI [6])
Drug Allergy | Adverse reaction to drug | Adverse reaction Investigational New Drugs | Adverse reaction Nitrates | Adverse reaction Nitrites | Amlodipine allergy | Adverse reaction ISMN ER
Item
participant has a history of significant drug allergy or any clinically significant adverse experience of a serious nature related to the administration of either a marketed or an investigational drug, including nitrates, nitrites, amlodipine, and ismn er
boolean
C0013182 (UMLS CUI [1])
C0041755 (UMLS CUI [2])
C0559546 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0559546 (UMLS CUI [4,1])
C0028125 (UMLS CUI [4,2])
C0559546 (UMLS CUI [5,1])
C0028137 (UMLS CUI [5,2])
C0570921 (UMLS CUI [6])
C0559546 (UMLS CUI [7,1])
C0064079 (UMLS CUI [7,2])
C1707968 (UMLS CUI [7,3])
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