ID

26678

Descrição

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

Palavras-chave

Versões (2)
  1. 27/08/2017 27/08/2017 -
  2. 23/10/2017 23/10/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

23 de outubro de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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Medical Conditions GSK study Chronic Coronary Heart Disease NCT00799903

Inglês

Medical Conditions GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulários  
Coronary heart disease
Descrição

Coronary heart disease

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

Prior myocardial infarction

Tipo de dados

integer

Date of diagnosis
Descrição

Myocardial infarction, date of diagnosis

Tipo de dados

date

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

Percutaneous coronary intervention

Tipo de dados

integer

Date of diagnosis
Descrição

PCI, date of diagnosis

Tipo de dados

date

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

Coronary artery bypass graft (CABG)

Tipo de dados

integer

Date of diagnosis
Descrição

CABG date of diagnosis

Tipo de dados

date

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

Multivessel coronary heart disease

Tipo de dados

integer

Date of diagnosis
Descrição

Multivessel coronary heart disease, date of diagnosis

Tipo de dados

date

Diabetes mellitus (requiring pharmacotherapy)
Descrição

Diabetes mellitus (requiring pharmacotherapy)

5. Type 1 diabetes mellitus
Descrição

Type 1 diabetes mellitus

Tipo de dados

integer

Date of diagnosis
Descrição

Type I diabetes mellitus, date of diagnosis

Tipo de dados

date

6. Type II diabetes mellitus requiring pharmacotherapy
Descrição

Type II diabetes mellitus

Tipo de dados

integer

Date of diagnosis
Descrição

Type II diabetes mellitus, date of diagnosis

Tipo de dados

date

Additional predictors of cardiovascular risk
Descrição

Additional predictors of cardiovascular risk

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

HDL Cholesterol

Tipo de dados

integer

Date of diagnosis
Descrição

HDL Cholesterol, date of diagnosis

Tipo de dados

date

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

Renal dysfunction eGFR

Tipo de dados

integer

Date of diagnosis
Descrição

Renal dysfunction eGFR, date of diagnosis

Tipo de dados

date

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

Renal dysfunction ACR

Tipo de dados

integer

Date of diagnosis
Descrição

Renal dysfunction ACR, date of diagnosis

Tipo de dados

date

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

Carotid artery Stenosis

Tipo de dados

integer

Date of diagnosis
Descrição

Carotid artery Stenosis, date of diagnosis

Tipo de dados

date

11. Carotid artery stenting
Descrição

Carotid artery stenting

Tipo de dados

integer

Date of diagnosis
Descrição

Carotid artery stenting, date of diagnosis

Tipo de dados

date

12. Carotid artery surgery
Descrição

Carotid artery surgery

Tipo de dados

integer

Date of diagnosis
Descrição

Carotid artery surgery, date of diagnosis

Tipo de dados

date

13. Prior ischaemic stroke [>3 months]
Descrição

ischaemic stroke

Tipo de dados

integer

Date of diagnosis
Descrição

ischaemic stroke, date of diagnosis

Tipo de dados

date

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

Intermittent claudication

Tipo de dados

integer

Date of diagnosis
Descrição

Intermittent claudication, date of diagnosis

Tipo de dados

date

15. Peripheral arterial stenting
Descrição

Peripheral arterial stenting

Tipo de dados

integer

Date of diagnosis
Descrição

Peripheral arterial stenting, date of diagnosis

Tipo de dados

date

16. Peripheral artery surgery
Descrição

Peripheral artery surgery

Tipo de dados

integer

Date of diagnosis
Descrição

Peripheral artery surgery, date of diagnosis

Tipo de dados

date

17. Peripheral artery disease with amputation
Descrição

Peripheral artery disease with amputation

Tipo de dados

integer

Date of diagnosis
Descrição

Peripheral artery disease with amputation, date of diagnosis

Tipo de dados

date

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

Ankle brachial index decreased

Tipo de dados

integer

Date of dignosis
Descrição

Ankle brachial index decreased, date of dignosis

Tipo de dados

date

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Similar models

Medical Conditions GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Coronary heart disease
Item
1. Prior myocardial infarction [>1 month prior to randomisation]
integer
Prior myocardial infarction
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
Prior myocardial infarction
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
Prior myocardial infarction
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
Prior myocardial infarction
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
Prior myocardial infarction
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
Prior myocardial infarction
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
Prior myocardial infarction
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
Prior myocardial infarction
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
Prior myocardial infarction
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
Prior myocardial infarction
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
Prior myocardial infarction
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
Prior myocardial infarction
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
Prior myocardial infarction
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
Prior myocardial infarction
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
Peripheral arterial stenting
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
Peripheral artery surgery
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
Peripheral artery disease with amputation
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
Ankle brachial index decreased
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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