ID

40827

Description

PRO-POWER: Hypertension With Risk Factors for a Duration of 24 Weeks With Micardis 80mg/Micardis Plus 80mg/12.5mg; ODM derived from: https://clinicaltrials.gov/show/NCT00936208

Link

https://clinicaltrials.gov/show/NCT00936208

Keywords

Versions (1)
  1. 5/20/20 5/20/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 20, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00936208

English

Eligibility Hypertension NCT00936208

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
aged 20 to 80 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
adult with essential hypertension - either newly diagnosed and untreated, or previously treated and uncontrolled
Description

Adult | Essential Hypertension Untreated | Essential Hypertension Treated Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C0085580
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C0085580
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C0205318
sitting blood pressure: systolic bp > 140 mmhg but < 180 mmhg, and/or diastolic bp > 90 mmhg but < 110 mmhg)
Description

Sitting systolic blood pressure | Sitting diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1319893
UMLS CUI [2]
C1319894
at least one cardiovascular known risk factor other than hypertension: diabetes/hyperglycaemia, cholesterol /dyslipidemia, a previous cardiovascular event, target organ damage, family history of hypertension or cardiovascular diseases, old age defined as > 55 years (males), > 65 years (females), smoking, overweight or obese patients or a combination of above risk factors
Description

Cardiovascular risk factor Quantity | Exception Hypertensive disease | Diabetes Mellitus | Hyperglycemia | Cholesterol | Dyslipidemias | Cardiovascular event | Target Organ Damage | Family history of Hypertension | Family history of Cardiovascular disease | Age | Gender | Tobacco use | Overweight | Obesity

Data type

boolean

Alias
UMLS CUI [1,1]
C0850624
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0020538
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0020456
UMLS CUI [5]
C0008377
UMLS CUI [6]
C0242339
UMLS CUI [7]
C1320716
UMLS CUI [8,1]
C1521840
UMLS CUI [8,2]
C0178784
UMLS CUI [8,3]
C0010957
UMLS CUI [9]
C0455405
UMLS CUI [10]
C0455404
UMLS CUI [11]
C0001779
UMLS CUI [12]
C0079399
UMLS CUI [13]
C0543414
UMLS CUI [14]
C0497406
UMLS CUI [15]
C0028754
patients who are assessed to benefit from the intake of angiotensin ii receptor blocker (arb) monotherapy or as add-on medication
Description

Patients Benefit Angiotensin II receptor antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0814225
UMLS CUI [1,3]
C0521942
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with contraindications to telmisartan use (as per the micardis® tablets package insert).
Description

Medical contraindication Telmisartan

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0248719
known hypersensitivity to the active ingredient or to any of the excipients of micardis® .
Description

Hypersensitivity Ingredient Micardis | Hypersensitivity Excipient Micardis

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1550600
UMLS CUI [1,3]
C0721704
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0015237
UMLS CUI [2,3]
C0721704
any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.
Description

Other medical condition Investigational New Drugs At risk

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1444641
patients participating in any other clinical trial.
Description

Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
patients already on micardis® alone or combination
Description

Micardis Pre-existing | Micardis Combination Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0721704
UMLS CUI [1,2]
C2347662
UMLS CUI [2,1]
C0721704
UMLS CUI [2,2]
C0205195
UMLS CUI [2,3]
C2347662
pregnant females, or females breast feeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Hypertension NCT00936208

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
male or female
boolean
C0079399 (UMLS CUI [1])
Age
Item
aged 20 to 80 years old.
boolean
C0001779 (UMLS CUI [1])
Adult | Essential Hypertension Untreated | Essential Hypertension Treated Uncontrolled
Item
adult with essential hypertension - either newly diagnosed and untreated, or previously treated and uncontrolled
boolean
C0001675 (UMLS CUI [1])
C0085580 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0085580 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
Sitting systolic blood pressure | Sitting diastolic blood pressure
Item
sitting blood pressure: systolic bp > 140 mmhg but < 180 mmhg, and/or diastolic bp > 90 mmhg but < 110 mmhg)
boolean
C1319893 (UMLS CUI [1])
C1319894 (UMLS CUI [2])
Cardiovascular risk factor Quantity | Exception Hypertensive disease | Diabetes Mellitus | Hyperglycemia | Cholesterol | Dyslipidemias | Cardiovascular event | Target Organ Damage | Family history of Hypertension | Family history of Cardiovascular disease | Age | Gender | Tobacco use | Overweight | Obesity
Item
at least one cardiovascular known risk factor other than hypertension: diabetes/hyperglycaemia, cholesterol /dyslipidemia, a previous cardiovascular event, target organ damage, family history of hypertension or cardiovascular diseases, old age defined as > 55 years (males), > 65 years (females), smoking, overweight or obese patients or a combination of above risk factors
boolean
C0850624 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0020538 (UMLS CUI [2,2])
C0011849 (UMLS CUI [3])
C0020456 (UMLS CUI [4])
C0008377 (UMLS CUI [5])
C0242339 (UMLS CUI [6])
C1320716 (UMLS CUI [7])
C1521840 (UMLS CUI [8,1])
C0178784 (UMLS CUI [8,2])
C0010957 (UMLS CUI [8,3])
C0455405 (UMLS CUI [9])
C0455404 (UMLS CUI [10])
C0001779 (UMLS CUI [11])
C0079399 (UMLS CUI [12])
C0543414 (UMLS CUI [13])
C0497406 (UMLS CUI [14])
C0028754 (UMLS CUI [15])
Patients Benefit Angiotensin II receptor antagonist
Item
patients who are assessed to benefit from the intake of angiotensin ii receptor blocker (arb) monotherapy or as add-on medication
boolean
C0030705 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C0521942 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Telmisartan
Item
patients with contraindications to telmisartan use (as per the micardis® tablets package insert).
boolean
C1301624 (UMLS CUI [1,1])
C0248719 (UMLS CUI [1,2])
Hypersensitivity Ingredient Micardis | Hypersensitivity Excipient Micardis
Item
known hypersensitivity to the active ingredient or to any of the excipients of micardis® .
boolean
C0020517 (UMLS CUI [1,1])
C1550600 (UMLS CUI [1,2])
C0721704 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
C0721704 (UMLS CUI [2,3])
Other medical condition Investigational New Drugs At risk
Item
any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.
boolean
C3843040 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
Study Subject Participation Status | Clinical Trial
Item
patients participating in any other clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Micardis Pre-existing | Micardis Combination Pre-existing
Item
patients already on micardis® alone or combination
boolean
C0721704 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0721704 (UMLS CUI [2,1])
C0205195 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant females, or females breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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