ID

26678

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: Medical Conditions

Keywords

  1. 8/27/17 8/27/17 -
  2. 10/23/17 10/23/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 23, 2017

DOI

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License

Creative Commons BY-NC 3.0

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Medical Conditions GSK study Chronic Coronary Heart Disease NCT00799903

Medical Conditions GSK study Chronic Coronary Heart Disease NCT00799903

Coronary heart disease
Description

Coronary heart disease

1. Prior myocardial infarction [>1 month prior to randomisation]
Description

Prior myocardial infarction

Data type

integer

Date of diagnosis
Description

Myocardial infarction, date of diagnosis

Data type

date

2. Percutaneous coronary intervention (PCI) [>1 month prior to randomisation]
Description

Percutaneous coronary intervention

Data type

integer

Date of diagnosis
Description

PCI, date of diagnosis

Data type

date

3. Coronary artery bypass graft (CABG) [>3 months prior to randomisation]
Description

Coronary artery bypass graft (CABG)

Data type

integer

Date of diagnosis
Description

CABG date of diagnosis

Data type

date

4. Multivessel coronary heart disease confirmed by angiography (without revascularization)
Description

Multivessel coronary heart disease

Data type

integer

Date of diagnosis
Description

Multivessel coronary heart disease, date of diagnosis

Data type

date

Diabetes mellitus (requiring pharmacotherapy)
Description

Diabetes mellitus (requiring pharmacotherapy)

5. Type 1 diabetes mellitus
Description

Type 1 diabetes mellitus

Data type

integer

Date of diagnosis
Description

Type I diabetes mellitus, date of diagnosis

Data type

date

6. Type II diabetes mellitus requiring pharmacotherapy
Description

Type II diabetes mellitus

Data type

integer

Date of diagnosis
Description

Type II diabetes mellitus, date of diagnosis

Data type

date

Additional predictors of cardiovascular risk
Description

Additional predictors of cardiovascular risk

7. Low HDL Cholesterol [<40 mg/dL or 1.03 mmol/L]
Description

HDL Cholesterol

Data type

integer

Date of diagnosis
Description

HDL Cholesterol, date of diagnosis

Data type

date

8. Significant renal dysfunction based on/confirmed by estimated glomerular filtration rate [>30 and <59 mL/min per 1.73 m2]
Description

Renal dysfunction eGFR

Data type

integer

Date of diagnosis
Description

Renal dysfunction eGFR, date of diagnosis

Data type

date

9. Renal dysfunction based on/confirmed by urine albumin:creatinine ratio (ACR) [>30 mg albumin/g creatinine]
Description

Renal dysfunction ACR

Data type

integer

Date of diagnosis
Description

Renal dysfunction ACR, date of diagnosis

Data type

date

10. Carotid artery Stenosis [unilateral or bilateral, >60%]
Description

Carotid artery Stenosis

Data type

integer

Date of diagnosis
Description

Carotid artery Stenosis, date of diagnosis

Data type

date

11. Carotid artery stenting
Description

Carotid artery stenting

Data type

integer

Date of diagnosis
Description

Carotid artery stenting, date of diagnosis

Data type

date

12. Carotid artery surgery
Description

Carotid artery surgery

Data type

integer

Date of diagnosis
Description

Carotid artery surgery, date of diagnosis

Data type

date

13. Prior ischaemic stroke [>3 months]
Description

ischaemic stroke

Data type

integer

Date of diagnosis
Description

ischaemic stroke, date of diagnosis

Data type

date

14. Intermittent claudication [with objective evidence of vascular origin]
Description

Intermittent claudication

Data type

integer

Date of diagnosis
Description

Intermittent claudication, date of diagnosis

Data type

date

15. Peripheral arterial stenting
Description

Peripheral arterial stenting

Data type

integer

Date of diagnosis
Description

Peripheral arterial stenting, date of diagnosis

Data type

date

16. Peripheral artery surgery
Description

Peripheral artery surgery

Data type

integer

Date of diagnosis
Description

Peripheral artery surgery, date of diagnosis

Data type

date

17. Peripheral artery disease with amputation
Description

Peripheral artery disease with amputation

Data type

integer

Date of diagnosis
Description

Peripheral artery disease with amputation, date of diagnosis

Data type

date

18. Ankle brachial index decreased [<0.9 in at least one ankle]
Description

Ankle brachial index decreased

Data type

integer

Date of dignosis
Description

Ankle brachial index decreased, date of dignosis

Data type

date

Similar models

Medical Conditions GSK study Chronic Coronary Heart Disease NCT00799903

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Coronary heart disease
Item
1. Prior myocardial infarction [>1 month prior to randomisation]
integer
Code List
1. Prior myocardial infarction [>1 month prior to randomisation]
CL Item
Current (1)
CL Item
No medical condition (5)
Myocardial infarction, date of diagnosis
Item
Date of diagnosis
date
Item
2. Percutaneous coronary intervention (PCI) [>1 month prior to randomisation]
integer
Code List
2. Percutaneous coronary intervention (PCI) [>1 month prior to randomisation]
CL Item
Current (1)
CL Item
No medical condition (5)
PCI, date of diagnosis
Item
Date of diagnosis
date
Item
3. Coronary artery bypass graft (CABG) [>3 months prior to randomisation]
integer
Code List
3. Coronary artery bypass graft (CABG) [>3 months prior to randomisation]
CL Item
Current (1)
CL Item
No medical condition (5)
CABG date of diagnosis
Item
Date of diagnosis
date
Item
4. Multivessel coronary heart disease confirmed by angiography (without revascularization)
integer
Code List
4. Multivessel coronary heart disease confirmed by angiography (without revascularization)
CL Item
Current (1)
CL Item
No medical condition (5)
Multivessel coronary heart disease, date of diagnosis
Item
Date of diagnosis
date
Item Group
Diabetes mellitus (requiring pharmacotherapy)
Item
5. Type 1 diabetes mellitus
integer
Code List
5. Type 1 diabetes mellitus
CL Item
Current (1)
CL Item
No medical condition (5)
Type I diabetes mellitus, date of diagnosis
Item
Date of diagnosis
date
Item
6. Type II diabetes mellitus requiring pharmacotherapy
integer
Code List
6. Type II diabetes mellitus requiring pharmacotherapy
CL Item
Current (1)
CL Item
No medical condition (5)
Type II diabetes mellitus, date of diagnosis
Item
Date of diagnosis
date
Item Group
Additional predictors of cardiovascular risk
Item
7. Low HDL Cholesterol [<40 mg/dL or 1.03 mmol/L]
integer
Code List
7. Low HDL Cholesterol [<40 mg/dL or 1.03 mmol/L]
CL Item
Current (1)
CL Item
No medical condition (5)
HDL Cholesterol, date of diagnosis
Item
Date of diagnosis
date
Item
8. Significant renal dysfunction based on/confirmed by estimated glomerular filtration rate [>30 and <59 mL/min per 1.73 m2]
integer
Code List
8. Significant renal dysfunction based on/confirmed by estimated glomerular filtration rate [>30 and <59 mL/min per 1.73 m2]
CL Item
Current (1)
CL Item
No medical condition (5)
Renal dysfunction eGFR, date of diagnosis
Item
Date of diagnosis
date
Item
9. Renal dysfunction based on/confirmed by urine albumin:creatinine ratio (ACR) [>30 mg albumin/g creatinine]
integer
Code List
9. Renal dysfunction based on/confirmed by urine albumin:creatinine ratio (ACR) [>30 mg albumin/g creatinine]
CL Item
Current (1)
CL Item
No medical condition (5)
Renal dysfunction ACR, date of diagnosis
Item
Date of diagnosis
date
Item
10. Carotid artery Stenosis [unilateral or bilateral, >60%]
integer
Code List
10. Carotid artery Stenosis [unilateral or bilateral, >60%]
CL Item
Current (1)
CL Item
No medical condition (5)
Carotid artery Stenosis, date of diagnosis
Item
Date of diagnosis
date
Item
11. Carotid artery stenting
integer
Code List
11. Carotid artery stenting
CL Item
Current (1)
CL Item
No medical condition (5)
Carotid artery stenting, date of diagnosis
Item
Date of diagnosis
date
Item
12. Carotid artery surgery
integer
Code List
12. Carotid artery surgery
CL Item
Current (1)
CL Item
No medical condition (5)
Carotid artery surgery, date of diagnosis
Item
Date of diagnosis
date
Item
13. Prior ischaemic stroke [>3 months]
integer
Code List
13. Prior ischaemic stroke [>3 months]
CL Item
Current (1)
CL Item
No medical condition (5)
ischaemic stroke, date of diagnosis
Item
Date of diagnosis
date
Item
14. Intermittent claudication [with objective evidence of vascular origin]
integer
Code List
14. Intermittent claudication [with objective evidence of vascular origin]
CL Item
Current (1)
CL Item
No medical condition (5)
Intermittent claudication, date of diagnosis
Item
Date of diagnosis
date
Item
15. Peripheral arterial stenting
integer
Code List
15. Peripheral arterial stenting
CL Item
Current (1)
CL Item
No medical condition (5)
Peripheral arterial stenting, date of diagnosis
Item
Date of diagnosis
date
Item
16. Peripheral artery surgery
integer
Code List
16. Peripheral artery surgery
CL Item
Current (1)
CL Item
No medical condition (5)
Peripheral artery surgery, date of diagnosis
Item
Date of diagnosis
date
Item
17. Peripheral artery disease with amputation
integer
Code List
17. Peripheral artery disease with amputation
CL Item
Current (1)
CL Item
No medical condition (5)
Peripheral artery disease with amputation, date of diagnosis
Item
Date of diagnosis
date
Item
18. Ankle brachial index decreased [<0.9 in at least one ankle]
integer
Code List
18. Ankle brachial index decreased [<0.9 in at least one ankle]
CL Item
Current (1)
CL Item
No medical condition (5)
Ankle brachial index decreased, date of dignosis
Item
Date of dignosis
date

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