ID

26697

Description

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Hospitalisation - Repeating form (Scheduled visits)

Keywords

Versions (4)
  1. 9/27/17 9/27/17 -
  2. 10/4/17 10/4/17 -
  3. 10/23/17 10/23/17 -
  4. 1/1/18 1/1/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 23, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Hospitalisation Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

English

Eligibility Chronic Kidney Disease NCT01003275

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
estimated glomerular filtration rate of 15-59 ml/min/1.73m2
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
fasting glucose 100-125 mg/dl
Description

Glucose measurement, fasting

Data type

boolean

Alias
UMLS CUI [1]
C0202045
18 years and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosed with diabetes mellitus
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
use of diabetes medications (insulin or oral hypoglycemics)
Description

Taking medication for diabetes | Insulin | Oral hypoglycemic

Data type

boolean

Alias
UMLS CUI [1]
C2054148
UMLS CUI [2]
C0021641
UMLS CUI [3]
C0359086
prior dialysis or transplantation
Description

Dialysis | Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0011946
UMLS CUI [2]
C0040732
planning to leave the area within 6 months
Description

Relocation of home Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1301732
participation in another clinical trial within 30 days
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
treatment with paricalcitol, calcitriol, or corticosteroids in the preceding 8 weeks
Description

paricalcitol | Calcitriol | Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0249582
UMLS CUI [2]
C0006674
UMLS CUI [3]
C0001617
serum calcium more than 10.2 mg/dl
Description

Serum calcium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0728876
pregnancy or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
change in dose (within 8 weeks) of fibrates, niacin, ace inhibitors, angiotensin receptor blockers, thiazide diuretics, beta-blockers, cholecalciferol or ergocalciferol
Description

Fibrates Dose changed | Niacin Dose changed | Angiotensin-Converting Enzyme Inhibitors Dose changed | Angiotensin II receptor antagonist Dose changed | Thiazide Diuretics Dose changed | Adrenergic beta-Antagonists Dose changed | Cholecalciferol Dose changed | Ergocalciferol Dose changed

Data type

boolean

Alias
UMLS CUI [1,1]
C1449704
UMLS CUI [1,2]
C1608430
UMLS CUI [2,1]
C0027996
UMLS CUI [2,2]
C1608430
UMLS CUI [3,1]
C0003015
UMLS CUI [3,2]
C1608430
UMLS CUI [4,1]
C0521942
UMLS CUI [4,2]
C1608430
UMLS CUI [5,1]
C0012802
UMLS CUI [5,2]
C1608430
UMLS CUI [6,1]
C0001645
UMLS CUI [6,2]
C1608430
UMLS CUI [7,1]
C0008318
UMLS CUI [7,2]
C1608430
UMLS CUI [8,1]
C0014695
UMLS CUI [8,2]
C1608430
incontinent of urine
Description

Urinary Incontinence

Data type

boolean

Alias
UMLS CUI [1]
C0042024
cancer (other than skin cancer) within 5 years
Description

Malignant Neoplasms | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
tuberculosis
Description

Tuberculosis

Data type

boolean

Alias
UMLS CUI [1]
C0041296
sarcoidosis
Description

Sarcoidosis

Data type

boolean

Alias
UMLS CUI [1]
C0036202
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Similar models

Eligibility Chronic Kidney Disease NCT01003275

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Estimated Glomerular Filtration Rate
Item
estimated glomerular filtration rate of 15-59 ml/min/1.73m2
boolean
C3811844 (UMLS CUI [1])
Glucose measurement, fasting
Item
fasting glucose 100-125 mg/dl
boolean
C0202045 (UMLS CUI [1])
Age
Item
18 years and older
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus
Item
diagnosed with diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Taking medication for diabetes | Insulin | Oral hypoglycemic
Item
use of diabetes medications (insulin or oral hypoglycemics)
boolean
C2054148 (UMLS CUI [1])
C0021641 (UMLS CUI [2])
C0359086 (UMLS CUI [3])
Dialysis | Transplantation
Item
prior dialysis or transplantation
boolean
C0011946 (UMLS CUI [1])
C0040732 (UMLS CUI [2])
Relocation of home Planned
Item
planning to leave the area within 6 months
boolean
C2699029 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Study Subject Participation Status
Item
participation in another clinical trial within 30 days
boolean
C2348568 (UMLS CUI [1])
paricalcitol | Calcitriol | Adrenal Cortex Hormones
Item
treatment with paricalcitol, calcitriol, or corticosteroids in the preceding 8 weeks
boolean
C0249582 (UMLS CUI [1])
C0006674 (UMLS CUI [2])
C0001617 (UMLS CUI [3])
Serum calcium measurement
Item
serum calcium more than 10.2 mg/dl
boolean
C0728876 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Fibrates Dose changed | Niacin Dose changed | Angiotensin-Converting Enzyme Inhibitors Dose changed | Angiotensin II receptor antagonist Dose changed | Thiazide Diuretics Dose changed | Adrenergic beta-Antagonists Dose changed | Cholecalciferol Dose changed | Ergocalciferol Dose changed
Item
change in dose (within 8 weeks) of fibrates, niacin, ace inhibitors, angiotensin receptor blockers, thiazide diuretics, beta-blockers, cholecalciferol or ergocalciferol
boolean
C1449704 (UMLS CUI [1,1])
C1608430 (UMLS CUI [1,2])
C0027996 (UMLS CUI [2,1])
C1608430 (UMLS CUI [2,2])
C0003015 (UMLS CUI [3,1])
C1608430 (UMLS CUI [3,2])
C0521942 (UMLS CUI [4,1])
C1608430 (UMLS CUI [4,2])
C0012802 (UMLS CUI [5,1])
C1608430 (UMLS CUI [5,2])
C0001645 (UMLS CUI [6,1])
C1608430 (UMLS CUI [6,2])
C0008318 (UMLS CUI [7,1])
C1608430 (UMLS CUI [7,2])
C0014695 (UMLS CUI [8,1])
C1608430 (UMLS CUI [8,2])
Urinary Incontinence
Item
incontinent of urine
boolean
C0042024 (UMLS CUI [1])
Malignant Neoplasms | Exception Skin carcinoma
Item
cancer (other than skin cancer) within 5 years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Tuberculosis
Item
tuberculosis
boolean
C0041296 (UMLS CUI [1])
Sarcoidosis
Item
sarcoidosis
boolean
C0036202 (UMLS CUI [1])
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