ID

28042

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: Eligibility Question

Keywords

Versions (4)
  1. 8/27/17 8/27/17 -
  2. 10/13/17 10/13/17 -
  3. 10/23/17 10/23/17 -
  4. 12/12/17 12/12/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 12, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Question GSK study Chronic Coronary Heart Disease NCT00799903

English

Eligibility Question GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
Eligibility Question
Description

Eligibility Question

1. Did the subject meet all the entry criteria?
Description

entry criteria met

Data type

text

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Description

Inclusion Criteria

1. Signed written informed consent prior to beginning study-related procedures.
Description

Subject must understand the aims, investigational procedures and possible consequences of the study).

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. Male or female aged at least 18 years, inclusive, at screening. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy.
Description

Refer to Appendix 1: Highly Effective Methods For Avoidance Of Pregnancy In Women Of Childbearing Potential. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception.

Data type

boolean

Alias
UMLS CUI [1,1]
C0150831
UMLS CUI [1,2]
C0001779
3. Current treatment with statin therapy unless not indicated according to treatment guidelines or contraindicated in the opinion of the investigator.
Description

statin therapy

Data type

boolean

Alias
UMLS CUI [1]
C0360714
4. Chronic CHD documented
Description

Chronic CHD documented by at least one of the following: a. prior MI (>1 month prior to randomisation). b. prior coronary revascularization procedure [percutaneous coronary intervention (PCI) > 1 month prior to randomization or coronary artery bypass graft (CABG) >3 months prior to randomization]. c. multivessel CHD involving major epicardial coronary arteries confirmed by coronary angiography at any time (without revascularization).

Data type

boolean

Alias
UMLS CUI [1]
C0010068
5. At least one additional predictor of CV risk
Description

At least one of the following additional predictors of CV risk [a through f]: a. age >60 years at randomization. b. diabetes mellitus requiring pharmacothearpy. c. HDL-C <40 mg/dL (1.03 mmol/L). d. smoker (defined as at least 5 cigarettes per day on average) or a previous smoker (defined as at least 5 cigarettes per day on average when smoking) who discontinued within the past 3 months. e. significant renal dysfunction (defined as estimated glomerular filtration rate [eGFR] >30 and <59 mL/min per 1.73 m2 OR urine ACR >30 mg albumin/g creatinine). f. polyvascular disease manifested as coexistent clinically diagnosed arterial disease in at least 2 arterial territories, defined as: > chronic CHD and cerebrovascular disease defined as carotid artery disease or prior ischemic stroke >3 months. OR > chronic CHD and peripheral arterial disease (PAD).

Data type

boolean

Alias
UMLS CUI [1]
C0850624
Exclusion Criteria
Description

Exclusion Criteria

1. Planned coronary revascularization (PCI or CABG) or any other major surgical procedure.
Description

Planned coronary revascularization

Data type

boolean

Alias
UMLS CUI [1]
C0877341
2. Current liver disease, known hepatic or biliary abnormalities or evidence of abnormal liver function test or other hepatic abnormalities.
Description

Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or evidence of abnormal liver function test [total bilirubin or alkaline phosphatase >1.5 x upper limit of normal (ULN); or ALT or AST >2.5 x ULN] or other hepatic abnormalities that in the opinion of the Investigator would preclude the subject from participation in the study.

Data type

boolean

Alias
UMLS CUI [1]
C0023895
3. Severe renal impairment (eGFR <30 mL/min/1.73 m2) or history of nephrectomy or kidney transplant (regardless of renal function).
Description

renal impairment

Data type

boolean

Alias
UMLS CUI [1]
C1565489
4. Current severe heart failure (New York Heart Association class III or IV).
Description

heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018801
5. Poorly controlled hypertension despite lifestyle modifications and pharmacotherapy.
Description

hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0020538
6. Any life-threatening condition with life expectancy <2 years, other than vascular disease, that might prevent the subject from completing the study.
Description

(e.g., very severe chronic airways disease, known human immunodeficiency virus [HIV] positive, or cancer in the past five years other than non-melanoma skin cancer).

Data type

boolean

Alias
UMLS CUI [1,1]
C2826244
UMLS CUI [1,2]
C0012634
7. Severe asthma that is poorly controlled on pharmacotherapy.
Description

asthma

Data type

boolean

Alias
UMLS CUI [1]
C0004096
8. Positive pregnancy test or is known to be pregnant or lactating.
Description

All female subjects of childbearing potential must have a urine ß?-human chorionic gonadotropin [hCG] pregnancy test performed at Screening and/or within 7 days prior to randomization.

Data type

boolean

Alias
UMLS CUI [1]
C0032961
9. History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions, or severe allergic responses.
Description

Refer to Appendix 2: Clinical criteria for diagnosing anaphylaxis [Sampson, 2006]

Data type

boolean

Alias
UMLS CUI [1]
C0002792
10. Alcohol or drug abuse within the past 6 months, or current mental condition (psychiatric disorder, senility or dementia), which may affect study compliance or prevent understanding of the aims, investigational procedures or possible consequences of the study.
Description

Alcohol or drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
11. Current or planned chronic administration of strong oral or injectable cytochrome P-450 isoenzyme 3A4 (CYP3A4) inhibitors.
Description

intake CYP3A4 inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C3830624
12. Subjects with both parents of Japanese, Chinese or Korean ancestry must have a blood sample collected for assessment of Lp-PLA2 activity by the central laboratory prior to randomization. Those with Lp-PLA 2 activity <10 nmol/min/mL will be excluded from participation in the study.
Description

Lp-PLA2 activity

Data type

boolean

Alias
UMLS CUI [1]
C0031671
13. Previous exposure to darapladib (SB-480848).
Description

exposure to darapladib

Data type

boolean

Alias
UMLS CUI [1]
C2348075
14. Use of another investigational product within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of darapladib or matching placebo.
Description

Use of another investigational product

Data type

boolean

Alias
UMLS CUI [1]
C0304229
15. Currently in a study of an investigational device.
Description

study of investigational device

Data type

boolean

Alias
UMLS CUI [1]
C2346570
16. Any other reason the investigator deems the subject to be unsuitable for the study.
Description

other reason for exclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C3840932
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Similar models

Eligibility Question GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Eligibility Question
Item
1. Did the subject meet all the entry criteria?
text
C1516637 (UMLS CUI [1])
Date and time sample taken
Code List
1. Did the subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No, please select all boxes corresponding to violations of any inclusion/exclusion criteria (N)
Item Group
Inclusion Criteria
informed consent
Item
1. Signed written informed consent prior to beginning study-related procedures.
boolean
C0021430 (UMLS CUI [1])
Age and sex
Item
2. Male or female aged at least 18 years, inclusive, at screening. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy.
boolean
C0150831 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
statin therapy
Item
3. Current treatment with statin therapy unless not indicated according to treatment guidelines or contraindicated in the opinion of the investigator.
boolean
C0360714 (UMLS CUI [1])
Chronic CHD
Item
4. Chronic CHD documented
boolean
C0010068 (UMLS CUI [1])
additional predictor of CV risk
Item
5. At least one additional predictor of CV risk
boolean
C0850624 (UMLS CUI [1])
Item Group
Exclusion Criteria
Planned coronary revascularization
Item
1. Planned coronary revascularization (PCI or CABG) or any other major surgical procedure.
boolean
C0877341 (UMLS CUI [1])
Liver disease
Item
2. Current liver disease, known hepatic or biliary abnormalities or evidence of abnormal liver function test or other hepatic abnormalities.
boolean
C0023895 (UMLS CUI [1])
renal impairment
Item
3. Severe renal impairment (eGFR <30 mL/min/1.73 m2) or history of nephrectomy or kidney transplant (regardless of renal function).
boolean
C1565489 (UMLS CUI [1])
heart failure
Item
4. Current severe heart failure (New York Heart Association class III or IV).
boolean
C0018801 (UMLS CUI [1])
hypertension
Item
5. Poorly controlled hypertension despite lifestyle modifications and pharmacotherapy.
boolean
C0020538 (UMLS CUI [1])
life-threatening condition
Item
6. Any life-threatening condition with life expectancy <2 years, other than vascular disease, that might prevent the subject from completing the study.
boolean
C2826244 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
asthma
Item
7. Severe asthma that is poorly controlled on pharmacotherapy.
boolean
C0004096 (UMLS CUI [1])
pregnancy
Item
8. Positive pregnancy test or is known to be pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
anaphylaxis
Item
9. History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions, or severe allergic responses.
boolean
C0002792 (UMLS CUI [1])
Alcohol or drug abuse
Item
10. Alcohol or drug abuse within the past 6 months, or current mental condition (psychiatric disorder, senility or dementia), which may affect study compliance or prevent understanding of the aims, investigational procedures or possible consequences of the study.
boolean
C0038586 (UMLS CUI [1])
intake CYP3A4 inhibitors
Item
11. Current or planned chronic administration of strong oral or injectable cytochrome P-450 isoenzyme 3A4 (CYP3A4) inhibitors.
boolean
C3830624 (UMLS CUI [1])
Lp-PLA2 activity
Item
12. Subjects with both parents of Japanese, Chinese or Korean ancestry must have a blood sample collected for assessment of Lp-PLA2 activity by the central laboratory prior to randomization. Those with Lp-PLA 2 activity <10 nmol/min/mL will be excluded from participation in the study.
boolean
C0031671 (UMLS CUI [1])
exposure to darapladib
Item
13. Previous exposure to darapladib (SB-480848).
boolean
C2348075 (UMLS CUI [1])
Use of another investigational product
Item
14. Use of another investigational product within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of darapladib or matching placebo.
boolean
C0304229 (UMLS CUI [1])
study of investigational device
Item
15. Currently in a study of an investigational device.
boolean
C2346570 (UMLS CUI [1])
other reason for exclusion
Item
16. Any other reason the investigator deems the subject to be unsuitable for the study.
boolean
C0680251 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
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