ID

39979

Beschreibung

MK-0954E Phase III Long-Term Study in Participants With Hypertension (MK-0954E-356); ODM derived from: https://clinicaltrials.gov/show/NCT01299376

Link

https://clinicaltrials.gov/show/NCT01299376

Stichworte

Versionen (1)
  1. 07.03.20 07.03.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. März 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hypertension NCT01299376

Englisch

Eligibility Hypertension NCT01299376

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant has a diagnosis of essential hypertension.
Beschreibung

Essential Hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0085580
participant is being treated with a single, or dual combination treatment for hypertension and will be able to discontinue the prior antihypertensive medication.
Beschreibung

Antihypertensive therapy | Combined Modality Therapy Dual Hypertensive disease | Ability Discontinue Antihypertensive Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0585941
UMLS CUI [2,1]
C0009429
UMLS CUI [2,2]
C0205173
UMLS CUI [2,3]
C0020538
UMLS CUI [3,1]
C0085732
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0003364
participant has a mean trough sidbp of ≥ 90 mmhg and < 110 mmhg.
Beschreibung

Sitting diastolic blood pressure mean

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1319894
UMLS CUI [1,2]
C0444504
participant has a mean trough sisbp of ≥ 140 mmhg and < 200 mmhg.
Beschreibung

Sitting systolic blood pressure mean

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
participant has no clinically significant abnormality at screening visit.
Beschreibung

Abnormality Clinical Significance Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant is currently taking >2 antihypertensive medications.
Beschreibung

Antihypertensive Agents Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
participant has a history of significant multiple and/or severe allergies to ingredients of nu-lotan or preminent, amlodipine or dihydropyridine drug, and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines).
Beschreibung

Multiple allergies Ingredient Losartan Potassium | Severe allergy Ingredient Losartan Potassium | Multiple allergies Ingredient Preminent | Severe allergy Ingredient Preminent | Multiple allergies Ingredient Amlodipine | Severe allergy Ingredient Amlodipine | Multiple allergies Ingredient Dihydropyridine | Severe allergy Ingredient Dihydropyridine | Multiple allergies Ingredient Thiazide | Severe allergy Ingredient Thiazide | Multiple allergies Ingredient Chlorthalidone | Severe allergy Ingredient Chlorthalidone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0740281
UMLS CUI [1,2]
C1550600
UMLS CUI [1,3]
C0700492
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C1550600
UMLS CUI [2,3]
C0700492
UMLS CUI [3,1]
C0740281
UMLS CUI [3,2]
C1550600
UMLS CUI [3,3]
C0138304
UMLS CUI [4,1]
C2945656
UMLS CUI [4,2]
C1550600
UMLS CUI [4,3]
C0138304
UMLS CUI [5,1]
C0740281
UMLS CUI [5,2]
C1550600
UMLS CUI [5,3]
C0051696
UMLS CUI [6,1]
C2945656
UMLS CUI [6,2]
C1550600
UMLS CUI [6,3]
C0051696
UMLS CUI [7,1]
C0740281
UMLS CUI [7,2]
C1550600
UMLS CUI [7,3]
C0220821
UMLS CUI [8,1]
C2945656
UMLS CUI [8,2]
C1550600
UMLS CUI [8,3]
C0220821
UMLS CUI [9,1]
C0740281
UMLS CUI [9,2]
C1550600
UMLS CUI [9,3]
C0541746
UMLS CUI [10,1]
C2945656
UMLS CUI [10,2]
C1550600
UMLS CUI [10,3]
C0541746
UMLS CUI [11,1]
C0740281
UMLS CUI [11,2]
C1550600
UMLS CUI [11,3]
C0008294
UMLS CUI [12,1]
C2945656
UMLS CUI [12,2]
C1550600
UMLS CUI [12,3]
C0008294
participant is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history within the last year of drug or alcohol abuse or dependence.
Beschreibung

Recreational drug use | Illicit medication use | Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2]
C0281875
UMLS CUI [3]
C0038586
participant is pregnant or breastfeeding, or expecting to conceive or the pregnancy test is positive at screening visit (visit 1).
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned | Pregnancy test positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4]
C0240802
participant is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.
Beschreibung

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
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Ähnliche Modelle

Eligibility Hypertension NCT01299376

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Essential Hypertension
Item
participant has a diagnosis of essential hypertension.
boolean
C0085580 (UMLS CUI [1])
Antihypertensive therapy | Combined Modality Therapy Dual Hypertensive disease | Ability Discontinue Antihypertensive Agents
Item
participant is being treated with a single, or dual combination treatment for hypertension and will be able to discontinue the prior antihypertensive medication.
boolean
C0585941 (UMLS CUI [1])
C0009429 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C0020538 (UMLS CUI [2,3])
C0085732 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0003364 (UMLS CUI [3,3])
Sitting diastolic blood pressure mean
Item
participant has a mean trough sidbp of ≥ 90 mmhg and < 110 mmhg.
boolean
C1319894 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Sitting systolic blood pressure mean
Item
participant has a mean trough sisbp of ≥ 140 mmhg and < 200 mmhg.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Abnormality Clinical Significance Absent
Item
participant has no clinically significant abnormality at screening visit.
boolean
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Antihypertensive Agents Quantity
Item
participant is currently taking >2 antihypertensive medications.
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Multiple allergies Ingredient Losartan Potassium | Severe allergy Ingredient Losartan Potassium | Multiple allergies Ingredient Preminent | Severe allergy Ingredient Preminent | Multiple allergies Ingredient Amlodipine | Severe allergy Ingredient Amlodipine | Multiple allergies Ingredient Dihydropyridine | Severe allergy Ingredient Dihydropyridine | Multiple allergies Ingredient Thiazide | Severe allergy Ingredient Thiazide | Multiple allergies Ingredient Chlorthalidone | Severe allergy Ingredient Chlorthalidone
Item
participant has a history of significant multiple and/or severe allergies to ingredients of nu-lotan or preminent, amlodipine or dihydropyridine drug, and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines).
boolean
C0740281 (UMLS CUI [1,1])
C1550600 (UMLS CUI [1,2])
C0700492 (UMLS CUI [1,3])
C2945656 (UMLS CUI [2,1])
C1550600 (UMLS CUI [2,2])
C0700492 (UMLS CUI [2,3])
C0740281 (UMLS CUI [3,1])
C1550600 (UMLS CUI [3,2])
C0138304 (UMLS CUI [3,3])
C2945656 (UMLS CUI [4,1])
C1550600 (UMLS CUI [4,2])
C0138304 (UMLS CUI [4,3])
C0740281 (UMLS CUI [5,1])
C1550600 (UMLS CUI [5,2])
C0051696 (UMLS CUI [5,3])
C2945656 (UMLS CUI [6,1])
C1550600 (UMLS CUI [6,2])
C0051696 (UMLS CUI [6,3])
C0740281 (UMLS CUI [7,1])
C1550600 (UMLS CUI [7,2])
C0220821 (UMLS CUI [7,3])
C2945656 (UMLS CUI [8,1])
C1550600 (UMLS CUI [8,2])
C0220821 (UMLS CUI [8,3])
C0740281 (UMLS CUI [9,1])
C1550600 (UMLS CUI [9,2])
C0541746 (UMLS CUI [9,3])
C2945656 (UMLS CUI [10,1])
C1550600 (UMLS CUI [10,2])
C0541746 (UMLS CUI [10,3])
C0740281 (UMLS CUI [11,1])
C1550600 (UMLS CUI [11,2])
C0008294 (UMLS CUI [11,3])
C2945656 (UMLS CUI [12,1])
C1550600 (UMLS CUI [12,2])
C0008294 (UMLS CUI [12,3])
Recreational drug use | Illicit medication use | Substance Use Disorders
Item
participant is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history within the last year of drug or alcohol abuse or dependence.
boolean
C0013146 (UMLS CUI [1])
C0281875 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Pregnancy test positive
Item
participant is pregnant or breastfeeding, or expecting to conceive or the pregnancy test is positive at screening visit (visit 1).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0240802 (UMLS CUI [4])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
participant is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
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