ID

29916

Description

A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00631917

Link

https://clinicaltrials.gov/show/NCT00631917

Keywords

Versions (1)
  1. 4/27/18 4/27/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 27, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00631917

English

Eligibility Hypertension NCT00631917

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female outpatients, 50 years of age and older with a diagnosis of essential hypertension
Description

Age | Essential Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0085580
successful high quality colonoscopy at baseline including visualization of the entire colon and the cecum as confirmed by a photograph and collection of the rectal and cecal mucosal biopsy samples
Description

Colonoscopy | Entire colon Photograph | Cecum Photograph | Rectal biopsy sample Mucosal | Cecum biopsy sample Mucosal

Data type

boolean

Alias
UMLS CUI [1]
C0009378
UMLS CUI [2,1]
C1281569
UMLS CUI [2,2]
C0441468
UMLS CUI [3,1]
C0007531
UMLS CUI [3,2]
C0441468
UMLS CUI [4,1]
C0586753
UMLS CUI [4,2]
C0026724
UMLS CUI [5,1]
C4040663
UMLS CUI [5,2]
C0026724
all rectal, colon or cecal polyps found at baseline colonoscopy must be completely resected endoscopically at the time of the procedure.
Description

Colonoscopy | Rectal polyp Complete excision | Colonic Polyps Complete excision | Polyp of cecum Complete excision

Data type

boolean

Alias
UMLS CUI [1]
C0009378
UMLS CUI [2,1]
C0034887
UMLS CUI [2,2]
C0015250
UMLS CUI [3,1]
C0009376
UMLS CUI [3,2]
C0015250
UMLS CUI [4,1]
C1112566
UMLS CUI [4,2]
C0015250
patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation have been clearly explained to them (written informed consent).
Description

Study Subject Participation Status eligible | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548635
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previously treated in an aliskiren study.
Description

Prior Therapy Aliskiren Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1120110
UMLS CUI [1,3]
C0008976
current evidence of inflammatory bowel disease, the presence of colonic ulcerations (or other indices of colitis of any type) or colorectal carcinoma including carcinoma in situ found at baseline colonoscopy.
Description

Inflammatory Bowel Diseases | Ulceration of colon | Colitis Type Any | Colorectal Carcinoma In situ | Colonoscopy

Data type

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0267491
UMLS CUI [3,1]
C0009319
UMLS CUI [3,2]
C0332307
UMLS CUI [3,3]
C1552551
UMLS CUI [4,1]
C0009402
UMLS CUI [4,2]
C0444498
UMLS CUI [5]
C0009378
history of gastrointestinal carcinoma, crohn's disease, ulcerative colitis, microscopic colitis.
Description

Gastrointestinal carcinoma | Crohn Disease | Ulcerative Colitis | Colitis, Microscopic

Data type

boolean

Alias
UMLS CUI [1]
C0151544
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0009324
UMLS CUI [4]
C0400821
history of familial polyposis or hereditary nonpolyposis colorectal cancer.
Description

Polyposis Familial | Hereditary Nonpolyposis Colorectal Cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0334108
UMLS CUI [1,2]
C0241888
UMLS CUI [2]
C1333990
history of confirmed diverticulitis within 12 months of visit 1.
Description

Diverticulitis

Data type

boolean

Alias
UMLS CUI [1]
C0012813
history of celiac disease (gluten intolerance).
Description

Celiac Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007570
history of or current evidence on the baseline colonoscopy of melanosis coli.
Description

Melanosis coli | Colonoscopy

Data type

boolean

Alias
UMLS CUI [1]
C0221391
UMLS CUI [2]
C0009378
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Similar models

Eligibility Hypertension NCT00631917

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Essential Hypertension
Item
male or female outpatients, 50 years of age and older with a diagnosis of essential hypertension
boolean
C0001779 (UMLS CUI [1])
C0085580 (UMLS CUI [2])
Colonoscopy | Entire colon Photograph | Cecum Photograph | Rectal biopsy sample Mucosal | Cecum biopsy sample Mucosal
Item
successful high quality colonoscopy at baseline including visualization of the entire colon and the cecum as confirmed by a photograph and collection of the rectal and cecal mucosal biopsy samples
boolean
C0009378 (UMLS CUI [1])
C1281569 (UMLS CUI [2,1])
C0441468 (UMLS CUI [2,2])
C0007531 (UMLS CUI [3,1])
C0441468 (UMLS CUI [3,2])
C0586753 (UMLS CUI [4,1])
C0026724 (UMLS CUI [4,2])
C4040663 (UMLS CUI [5,1])
C0026724 (UMLS CUI [5,2])
Colonoscopy | Rectal polyp Complete excision | Colonic Polyps Complete excision | Polyp of cecum Complete excision
Item
all rectal, colon or cecal polyps found at baseline colonoscopy must be completely resected endoscopically at the time of the procedure.
boolean
C0009378 (UMLS CUI [1])
C0034887 (UMLS CUI [2,1])
C0015250 (UMLS CUI [2,2])
C0009376 (UMLS CUI [3,1])
C0015250 (UMLS CUI [3,2])
C1112566 (UMLS CUI [4,1])
C0015250 (UMLS CUI [4,2])
Study Subject Participation Status eligible | Informed Consent
Item
patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation have been clearly explained to them (written informed consent).
boolean
C2348568 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Aliskiren Clinical Trial
Item
previously treated in an aliskiren study.
boolean
C1514463 (UMLS CUI [1,1])
C1120110 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Inflammatory Bowel Diseases | Ulceration of colon | Colitis Type Any | Colorectal Carcinoma In situ | Colonoscopy
Item
current evidence of inflammatory bowel disease, the presence of colonic ulcerations (or other indices of colitis of any type) or colorectal carcinoma including carcinoma in situ found at baseline colonoscopy.
boolean
C0021390 (UMLS CUI [1])
C0267491 (UMLS CUI [2])
C0009319 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C1552551 (UMLS CUI [3,3])
C0009402 (UMLS CUI [4,1])
C0444498 (UMLS CUI [4,2])
C0009378 (UMLS CUI [5])
Gastrointestinal carcinoma | Crohn Disease | Ulcerative Colitis | Colitis, Microscopic
Item
history of gastrointestinal carcinoma, crohn's disease, ulcerative colitis, microscopic colitis.
boolean
C0151544 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
C0400821 (UMLS CUI [4])
Polyposis Familial | Hereditary Nonpolyposis Colorectal Cancer
Item
history of familial polyposis or hereditary nonpolyposis colorectal cancer.
boolean
C0334108 (UMLS CUI [1,1])
C0241888 (UMLS CUI [1,2])
C1333990 (UMLS CUI [2])
Diverticulitis
Item
history of confirmed diverticulitis within 12 months of visit 1.
boolean
C0012813 (UMLS CUI [1])
Celiac Disease
Item
history of celiac disease (gluten intolerance).
boolean
C0007570 (UMLS CUI [1])
Melanosis coli | Colonoscopy
Item
history of or current evidence on the baseline colonoscopy of melanosis coli.
boolean
C0221391 (UMLS CUI [1])
C0009378 (UMLS CUI [2])
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