ID

42935

Description

A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly; ODM derived from: https://clinicaltrials.gov/show/NCT00368277

Link

https://clinicaltrials.gov/show/NCT00368277

Keywords

Versions (2)
  1. 4/6/17 4/6/17 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00368277

English

Eligibility Hypertension NCT00368277

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female outpatients ≥ 65 years old.
Description

Outpatients | Age

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
patients with essential hypertension with an mssbp ≥ 140 mmhg and < 180 mmhg, and msdbp < 110 mmhg at visits 2 and 3. (visit 201 was deleted by the administrative changes document.)
Description

Essential Hypertension | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean

Data type

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2,1]
C1319893
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C1319894
UMLS CUI [3,2]
C0444504
patients must have had a difference in mssbp of ≤ 20 mmhg between visit 3 and the visit immediately prior to visit 3.
Description

Sitting systolic blood pressure mean Timepoint Difference

Data type

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C2348792
UMLS CUI [1,4]
C1705242
patients who were eligible and able to participate in the study, and who consented to do so after the purpose and nature of the investigation had been explained to them (written informed consent).
Description

Study Subject Participation Status | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of renal artery stenosis.
Description

Renal Artery Stenosis

Data type

boolean

Alias
UMLS CUI [1]
C0035067
known keith-wagener grade iii or iv hypertensive retinopathy.
Description

Hypertensive Retinopathy Grade

Data type

boolean

Alias
UMLS CUI [1,1]
C0152132
UMLS CUI [1,2]
C0441800
history of hypertensive encephalopathy.
Description

Hypertensive Encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C0151620
current diagnosis of heart failure (new york heart association class iii-iv).
Description

Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
history of transient ischemic cerebral attack or cerebrovascular accident within 6 months.
Description

Transient Ischemic Attack | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0007787
UMLS CUI [2]
C0038454
history of myocardial infarction, bypass surgery, or any percutaneous coronary intervention within 6 months.
Description

Myocardial Infarction | Bypass surgery | Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C1536078
UMLS CUI [3]
C1532338
current unstable angina pectoris. patients on a stable dose of oral or topical nitrates or beta blockers for angina were acceptable.
Description

Angina, Unstable | Nitrate Oral Dose Stable | Nitrate Topical Dose Stable | Adrenergic beta-1 Receptor Antagonists Dose Stable

Data type

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C0699857
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
UMLS CUI [3,1]
C0699857
UMLS CUI [3,2]
C1522168
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0205360
UMLS CUI [4,1]
C0304516
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
Description

Cardiac Arrhythmia Life Threatening | ARRHYTHMIA SYMPTOMATIC

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0741212
clinically significant valvular heart disease.
Description

Heart valve disease

Data type

boolean

Alias
UMLS CUI [1]
C0018824
concurrent use of any antihypersensitive medications except a stable dose 3 months prior to visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g., flomax for bph), beta blockers for angina, or beta blockers ophthalmic preparations.
Description

Antihypertensive Agents | Adrenergic alpha-Antagonists Dose Stable | Benign prostatic hypertrophy | Flomax | Adrenergic beta-1 Receptor Antagonists | Angina Pectoris | Adrenergic beta-1 Receptor Antagonists Ophthalmic

Data type

boolean

Alias
UMLS CUI [1]
C0003364
UMLS CUI [2,1]
C0001641
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C1704272
UMLS CUI [4]
C0662903
UMLS CUI [5]
C0304516
UMLS CUI [6]
C0002962
UMLS CUI [7,1]
C0304516
UMLS CUI [7,2]
C1522230
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Similar models

Eligibility Hypertension NCT00368277

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
male or female outpatients ≥ 65 years old.
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Essential Hypertension | Sitting systolic blood pressure mean | Sitting diastolic blood pressure mean
Item
patients with essential hypertension with an mssbp ≥ 140 mmhg and < 180 mmhg, and msdbp < 110 mmhg at visits 2 and 3. (visit 201 was deleted by the administrative changes document.)
boolean
C0085580 (UMLS CUI [1])
C1319893 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C1319894 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Sitting systolic blood pressure mean Timepoint Difference
Item
patients must have had a difference in mssbp of ≤ 20 mmhg between visit 3 and the visit immediately prior to visit 3.
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,3])
C1705242 (UMLS CUI [1,4])
Study Subject Participation Status | Informed Consent
Item
patients who were eligible and able to participate in the study, and who consented to do so after the purpose and nature of the investigation had been explained to them (written informed consent).
boolean
C2348568 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Renal Artery Stenosis
Item
history of renal artery stenosis.
boolean
C0035067 (UMLS CUI [1])
Hypertensive Retinopathy Grade
Item
known keith-wagener grade iii or iv hypertensive retinopathy.
boolean
C0152132 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Hypertensive Encephalopathy
Item
history of hypertensive encephalopathy.
boolean
C0151620 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
current diagnosis of heart failure (new york heart association class iii-iv).
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Transient Ischemic Attack | Cerebrovascular accident
Item
history of transient ischemic cerebral attack or cerebrovascular accident within 6 months.
boolean
C0007787 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
Myocardial Infarction | Bypass surgery | Percutaneous Coronary Intervention
Item
history of myocardial infarction, bypass surgery, or any percutaneous coronary intervention within 6 months.
boolean
C0027051 (UMLS CUI [1])
C1536078 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
Angina, Unstable | Nitrate Oral Dose Stable | Nitrate Topical Dose Stable | Adrenergic beta-1 Receptor Antagonists Dose Stable
Item
current unstable angina pectoris. patients on a stable dose of oral or topical nitrates or beta blockers for angina were acceptable.
boolean
C0002965 (UMLS CUI [1])
C0699857 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C0699857 (UMLS CUI [3,1])
C1522168 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
C0304516 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Cardiac Arrhythmia Life Threatening | ARRHYTHMIA SYMPTOMATIC
Item
concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
boolean
C0003811 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0741212 (UMLS CUI [2])
Heart valve disease
Item
clinically significant valvular heart disease.
boolean
C0018824 (UMLS CUI [1])
Antihypertensive Agents | Adrenergic alpha-Antagonists Dose Stable | Benign prostatic hypertrophy | Flomax | Adrenergic beta-1 Receptor Antagonists | Angina Pectoris | Adrenergic beta-1 Receptor Antagonists Ophthalmic
Item
concurrent use of any antihypersensitive medications except a stable dose 3 months prior to visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g., flomax for bph), beta blockers for angina, or beta blockers ophthalmic preparations.
boolean
C0003364 (UMLS CUI [1])
C0001641 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C1704272 (UMLS CUI [3])
C0662903 (UMLS CUI [4])
C0304516 (UMLS CUI [5])
C0002962 (UMLS CUI [6])
C0304516 (UMLS CUI [7,1])
C1522230 (UMLS CUI [7,2])
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