ID

12973

Description

Efficacy and Safety of Chronic Administration of Telmisartan as Monotherapy or in Combination With Hydrochlorothiazide or Other Antihypertensive Medications in Patients With Mild to Moderate Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT02177422

Link

https://clinicaltrials.gov/show/NCT02177422

Keywords

Versions (1)
  1. 1/8/16 1/8/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 8, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Hypertension NCT02177422

English

Eligibility Hypertension NCT02177422

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who have met the inclusion criteria for the preceding clinical trial of telmisartan. all patients must give a separate written informed consent for participation in the open-label follow-up.
Description

patients who have met the inclusion criteria for the preceding clinical trial of telmisartan. all patients must give a separate written informed consent for participation in the open-label follow-up.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0248719
mild-to-moderate essential hypertension defined as a mean seated diastolic blood pressure measurement of ≥ 95 mmhg measured by manual cuff sphygmomanometer
Description

hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0020538
mean seated systolic blood pressure ≥ 140 mmhg, measured my manual cuff
Description

mean seated systolic blood pressure ≥ 140 mmhg, measured my manual cuff

Data type

boolean

Alias
UMLS CUI [1]
C0005823
a 24-hour mean diastolic blood pressure, measured by abpm (ambulatory blood pressure measurement), of ≥ 85 mmhg
Description

a 24-hour mean diastolic blood pressure, measured by abpm (ambulatory blood pressure measurement), of ≥ 85 mmhg

Data type

boolean

Alias
UMLS CUI [1]
C0005823
age 18 or older
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient's written informed consent in accordance with gcp (good clinical practice) and local legislation
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a clinically significant change in ecg from baseline that was reported as an adverse event during the preceding clinical trial
Description

patients with a clinically significant change in ecg from baseline that was reported as an adverse event during the preceding clinical trial

Data type

boolean

Alias
UMLS CUI [1]
C1623258
patients who have developed a medical condition during the preceding clinical trial that, in the investigator's opinion, may be worsened by treatment or may compromise the safety evaluation of telmisartan
Description

patients who have developed a medical condition during the preceding clinical trial that, in the investigator's opinion, may be worsened by treatment or may compromise the safety evaluation of telmisartan

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
patients who discontinued the preceding telmisartan clinical trial due to an adverse event
Description

patients who discontinued the preceding telmisartan clinical trial due to an adverse event

Data type

boolean

Alias
UMLS CUI [1]
C2348568
any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan
Description

any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Hypertension NCT02177422

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
patients who have met the inclusion criteria for the preceding clinical trial of telmisartan. all patients must give a separate written informed consent for participation in the open-label follow-up.
Item
patients who have met the inclusion criteria for the preceding clinical trial of telmisartan. all patients must give a separate written informed consent for participation in the open-label follow-up.
boolean
C0021430 (UMLS CUI [1])
C0248719 (UMLS CUI [2])
hypertension
Item
mild-to-moderate essential hypertension defined as a mean seated diastolic blood pressure measurement of ≥ 95 mmhg measured by manual cuff sphygmomanometer
boolean
C0020538 (UMLS CUI [1])
mean seated systolic blood pressure ≥ 140 mmhg, measured my manual cuff
Item
mean seated systolic blood pressure ≥ 140 mmhg, measured my manual cuff
boolean
C0005823 (UMLS CUI [1])
a 24-hour mean diastolic blood pressure, measured by abpm (ambulatory blood pressure measurement), of ≥ 85 mmhg
Item
a 24-hour mean diastolic blood pressure, measured by abpm (ambulatory blood pressure measurement), of ≥ 85 mmhg
boolean
C0005823 (UMLS CUI [1])
age
Item
age 18 or older
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
patient's written informed consent in accordance with gcp (good clinical practice) and local legislation
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
patients with a clinically significant change in ecg from baseline that was reported as an adverse event during the preceding clinical trial
Item
patients with a clinically significant change in ecg from baseline that was reported as an adverse event during the preceding clinical trial
boolean
C1623258 (UMLS CUI [1])
patients who have developed a medical condition during the preceding clinical trial that, in the investigator's opinion, may be worsened by treatment or may compromise the safety evaluation of telmisartan
Item
patients who have developed a medical condition during the preceding clinical trial that, in the investigator's opinion, may be worsened by treatment or may compromise the safety evaluation of telmisartan
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
patients who discontinued the preceding telmisartan clinical trial due to an adverse event
Item
patients who discontinued the preceding telmisartan clinical trial due to an adverse event
boolean
C2348568 (UMLS CUI [1])
any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan
Item
any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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