ID

23186

Description

Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00498433

Link

https://clinicaltrials.gov/show/NCT00498433

Keywords

  1. 6/27/17 6/27/17 -
Uploaded on

June 27, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Hypertension NCT00498433

Eligibility Hypertension NCT00498433

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
part 1:
Description

ID.1

Data type

boolean

male and female patients 20 to 65 years of age with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0020538
UMLS CUI [1,3]
C0028754
for patients with a history of treated hypertension, mean sitting systolic blood pressure (mssbp)/ mean sitting diastolic blood pressure (msdbp) had to be ≥ 120/80 mmhg and ≤ 160/100 mm hg. for patients with newly diagnosed, untreated hypertension mssbp/msdbp had to be ≥ 135/85 mmhg and ≤ 160/100 mm hg
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0005823
pulse rate 40 - 90 bpm
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1]
C0232117
part 2:
Description

ID.5

Data type

boolean

male and female patients 18 to 65 years of age , with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0020538
UMLS CUI [1,3]
C0028754
systolic and diastolic blood pressure and pulse rate were assessed after the patient had rested for at least five (5) minutes. vital signs had to be within the following ranges:
Description

ID.7

Data type

boolean

1. patients with history of treated hypertension: mssbp/msdbp ≥ 135/85 mmhg and < 160/100 mmhg at baseline
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1]
C0005823
2. patients with newly diagnosed, untreated hypertension: mssbp/msdbp ≥ 135/85 mmhg and < 160/100 mmhg at screening and baseline.
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0332155
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
part 1
Description

ID.10

Data type

boolean

hypertension grade 2 (mssbp ≥ 160 mmhg) or grade 3 (msdbp ≥ 110 mmhg and/or mssbp ≥ 180 mmhg) who classification
Description

ID.11

Data type

boolean

Alias
UMLS CUI [1,1]
C1556274
UMLS CUI [1,2]
C1556275
UMLS CUI [1,3]
C1556276
current treatment with three or more antihypertensive drugs.
Description

ID.13

Data type

boolean

Alias
UMLS CUI [1]
C0003364
part 2
Description

ID.14

Data type

boolean

hypertension grade 2 (mssbp ≥ 160 and/or msdbp ≥ 100 mmhg).
Description

ID.15

Data type

boolean

Alias
UMLS CUI [1]
C1556273
current treatment with three or more antihypertensive drugs.
Description

ID.16

Data type

boolean

Alias
UMLS CUI [1]
C0003364
other protocol-defined inclusion/exclusion criteria applied
Description

ID.17

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251

Similar models

Eligibility Hypertension NCT00498433

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
part 1:
boolean
ID.2
Item
male and female patients 20 to 65 years of age with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)
boolean
C0001779 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
C0028754 (UMLS CUI [1,3])
ID.3
Item
for patients with a history of treated hypertension, mean sitting systolic blood pressure (mssbp)/ mean sitting diastolic blood pressure (msdbp) had to be ≥ 120/80 mmhg and ≤ 160/100 mm hg. for patients with newly diagnosed, untreated hypertension mssbp/msdbp had to be ≥ 135/85 mmhg and ≤ 160/100 mm hg
boolean
C0020538 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
ID.4
Item
pulse rate 40 - 90 bpm
boolean
C0232117 (UMLS CUI [1])
ID.5
Item
part 2:
boolean
ID.6
Item
male and female patients 18 to 65 years of age , with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)
boolean
C0001779 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
C0028754 (UMLS CUI [1,3])
ID.7
Item
systolic and diastolic blood pressure and pulse rate were assessed after the patient had rested for at least five (5) minutes. vital signs had to be within the following ranges:
boolean
ID.8
Item
1. patients with history of treated hypertension: mssbp/msdbp ≥ 135/85 mmhg and < 160/100 mmhg at baseline
boolean
C0005823 (UMLS CUI [1])
ID.9
Item
2. patients with newly diagnosed, untreated hypertension: mssbp/msdbp ≥ 135/85 mmhg and < 160/100 mmhg at screening and baseline.
boolean
C0005823 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
ID.10
Item
part 1
boolean
ID.11
Item
hypertension grade 2 (mssbp ≥ 160 mmhg) or grade 3 (msdbp ≥ 110 mmhg and/or mssbp ≥ 180 mmhg) who classification
boolean
C1556274 (UMLS CUI [1,1])
C1556275 (UMLS CUI [1,2])
C1556276 (UMLS CUI [1,3])
ID.13
Item
current treatment with three or more antihypertensive drugs.
boolean
C0003364 (UMLS CUI [1])
ID.14
Item
part 2
boolean
ID.15
Item
hypertension grade 2 (mssbp ≥ 160 and/or msdbp ≥ 100 mmhg).
boolean
C1556273 (UMLS CUI [1])
ID.16
Item
current treatment with three or more antihypertensive drugs.
boolean
C0003364 (UMLS CUI [1])
ID.17
Item
other protocol-defined inclusion/exclusion criteria applied
boolean
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial