ID

17623

Beschreibung

A Study on Ca Blocker Versus AII Antagonists in Hypertension With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00144144

Link

https://clinicaltrials.gov/show/NCT00144144

Stichworte

Versionen (1)
  1. 26.09.16 26.09.16 -
Hochgeladen am

26. September 2016

DOI

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Creative Commons BY 4.0
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Eligibility Hypertension NCT00144144

Englisch

Eligibility Hypertension NCT00144144

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 2 diabetes mellitus.
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
patients who have been treated by the single use of aii antagonist at usual for at least 8 weeks or patients who have been treated by the combined use of aii antagonist at usual doses and calcium channel blocker or a antihypertensive drug other than ace inhibitors for at least 8 weeks.
Beschreibung

Angiotensin II receptor antagonist | Calcium Channel Blockers | Antihypertensive Agents | Angiotensin-Converting Enzyme Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1]
C0521942
UMLS CUI [2]
C0006684
UMLS CUI [3]
C0003364
UMLS CUI [4]
C0003015
patients who show a systolic blood pressure (blood pressure) > 135 mm hg or a diastolic blood pressure > 85 mm hg, which is measured (in a sitting position) on an outpatient basis at the time of start of the observation period, and show the mean (blood pressure level measured at home after getting up before the start of study) of systolic blood pressure > 130 mm hg or diastolic blood pressure > 80 mm hg measured at home after getting up for last 5 days during the last 2-week observation period.
Beschreibung

Sitting systolic blood pressure | Sitting diastolic blood pressure | Blood Pressure | Systolic Pressure mean | Diastolic blood pressure mean

Datentyp

boolean

Alias
UMLS CUI [1]
C1319893
UMLS CUI [2]
C1319894
UMLS CUI [3]
C0005823
UMLS CUI [4,1]
C0871470
UMLS CUI [4,2]
C0444504
UMLS CUI [5,1]
C0428883
UMLS CUI [5,2]
C0444504
patients whose consent is obtained at age 20 years or over.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patients whose consent is obtained from themselves in written form. with regard to 2) and 3), however, the case, in which the mean of the systolic blood pressure levels measured at home after getting up for last 5 days during the first 1-week observation period is > 180 mm hg or the mean diastolic blood pressure level is > 110 mm hg, is included in the present study.
Beschreibung

Informed Consent | Systolic Pressure mean | Diastolic blood pressure mean

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0871470
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C0428883
UMLS CUI [3,2]
C0444504
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with secondary hypertension.
Beschreibung

Secondary hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0155616
patients who show a systolic blood pressure > 180 mm hg or diastolic blood pressure > 110 mm hg on the measurement (in a sitting position) on an outpatient basis at the time of start of the observation period.
Beschreibung

Sitting systolic blood pressure | Sitting diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C1319893
UMLS CUI [2]
C1319894
patients with severe hepatic dysfunction.
Beschreibung

Liver Dysfunction Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
patients with severe renal dysfunction.
Beschreibung

Renal dysfunction Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C0205082
patients with a past history of hypersensitiveness to study drugs.
Beschreibung

Hypersensitivity Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant during the study period.
Beschreibung

Pregnancy | Breast Feeding | Pregnancy Probably | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0750492
UMLS CUI [4]
C0032992
patients who have participated in the trial within 3 months before the start of the observation period or who attend the trial simultaneously with the present study.
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
other patients judged as being inappropriate for the subjects of the study by investigators.
Beschreibung

Study Subject Participation Status Inappropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Ähnliche Modelle

Eligibility Hypertension NCT00144144

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
patients with type 2 diabetes mellitus.
boolean
C0011860 (UMLS CUI [1])
Angiotensin II receptor antagonist | Calcium Channel Blockers | Antihypertensive Agents | Angiotensin-Converting Enzyme Inhibitors
Item
patients who have been treated by the single use of aii antagonist at usual for at least 8 weeks or patients who have been treated by the combined use of aii antagonist at usual doses and calcium channel blocker or a antihypertensive drug other than ace inhibitors for at least 8 weeks.
boolean
C0521942 (UMLS CUI [1])
C0006684 (UMLS CUI [2])
C0003364 (UMLS CUI [3])
C0003015 (UMLS CUI [4])
Sitting systolic blood pressure | Sitting diastolic blood pressure | Blood Pressure | Systolic Pressure mean | Diastolic blood pressure mean
Item
patients who show a systolic blood pressure (blood pressure) > 135 mm hg or a diastolic blood pressure > 85 mm hg, which is measured (in a sitting position) on an outpatient basis at the time of start of the observation period, and show the mean (blood pressure level measured at home after getting up before the start of study) of systolic blood pressure > 130 mm hg or diastolic blood pressure > 80 mm hg measured at home after getting up for last 5 days during the last 2-week observation period.
boolean
C1319893 (UMLS CUI [1])
C1319894 (UMLS CUI [2])
C0005823 (UMLS CUI [3])
C0871470 (UMLS CUI [4,1])
C0444504 (UMLS CUI [4,2])
C0428883 (UMLS CUI [5,1])
C0444504 (UMLS CUI [5,2])
Age
Item
patients whose consent is obtained at age 20 years or over.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Systolic Pressure mean | Diastolic blood pressure mean
Item
patients whose consent is obtained from themselves in written form. with regard to 2) and 3), however, the case, in which the mean of the systolic blood pressure levels measured at home after getting up for last 5 days during the first 1-week observation period is > 180 mm hg or the mean diastolic blood pressure level is > 110 mm hg, is included in the present study.
boolean
C0021430 (UMLS CUI [1])
C0871470 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0428883 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension
Item
patients with secondary hypertension.
boolean
C0155616 (UMLS CUI [1])
Sitting systolic blood pressure | Sitting diastolic blood pressure
Item
patients who show a systolic blood pressure > 180 mm hg or diastolic blood pressure > 110 mm hg on the measurement (in a sitting position) on an outpatient basis at the time of start of the observation period.
boolean
C1319893 (UMLS CUI [1])
C1319894 (UMLS CUI [2])
Liver Dysfunction Severe
Item
patients with severe hepatic dysfunction.
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Renal dysfunction Severe
Item
patients with severe renal dysfunction.
boolean
C3279454 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Hypersensitivity Investigational New Drugs
Item
patients with a past history of hypersensitiveness to study drugs.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Pregnancy Probably | Pregnancy, Planned
Item
pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant during the study period.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0750492 (UMLS CUI [3,2])
C0032992 (UMLS CUI [4])
Study Subject Participation Status
Item
patients who have participated in the trial within 3 months before the start of the observation period or who attend the trial simultaneously with the present study.
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status Inappropriate
Item
other patients judged as being inappropriate for the subjects of the study by investigators.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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