ID

26678

Beschreibung

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

Stichworte

Versionen (2)
  1. 27.08.17 27.08.17 -
  2. 23.10.17 23.10.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

23. Oktober 2017

DOI

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

Englisch

Medical Conditions GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare  
Coronary heart disease
Beschreibung

Coronary heart disease

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

Prior myocardial infarction

Datentyp

integer

Date of diagnosis
Beschreibung

Myocardial infarction, date of diagnosis

Datentyp

date

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

Percutaneous coronary intervention

Datentyp

integer

Date of diagnosis
Beschreibung

PCI, date of diagnosis

Datentyp

date

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

Coronary artery bypass graft (CABG)

Datentyp

integer

Date of diagnosis
Beschreibung

CABG date of diagnosis

Datentyp

date

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

Multivessel coronary heart disease

Datentyp

integer

Date of diagnosis
Beschreibung

Multivessel coronary heart disease, date of diagnosis

Datentyp

date

Diabetes mellitus (requiring pharmacotherapy)
Beschreibung

Diabetes mellitus (requiring pharmacotherapy)

5. Type 1 diabetes mellitus
Beschreibung

Type 1 diabetes mellitus

Datentyp

integer

Date of diagnosis
Beschreibung

Type I diabetes mellitus, date of diagnosis

Datentyp

date

6. Type II diabetes mellitus requiring pharmacotherapy
Beschreibung

Type II diabetes mellitus

Datentyp

integer

Date of diagnosis
Beschreibung

Type II diabetes mellitus, date of diagnosis

Datentyp

date

Additional predictors of cardiovascular risk
Beschreibung

Additional predictors of cardiovascular risk

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

HDL Cholesterol

Datentyp

integer

Date of diagnosis
Beschreibung

HDL Cholesterol, date of diagnosis

Datentyp

date

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

Renal dysfunction eGFR

Datentyp

integer

Date of diagnosis
Beschreibung

Renal dysfunction eGFR, date of diagnosis

Datentyp

date

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

Renal dysfunction ACR

Datentyp

integer

Date of diagnosis
Beschreibung

Renal dysfunction ACR, date of diagnosis

Datentyp

date

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

Carotid artery Stenosis

Datentyp

integer

Date of diagnosis
Beschreibung

Carotid artery Stenosis, date of diagnosis

Datentyp

date

11. Carotid artery stenting
Beschreibung

Carotid artery stenting

Datentyp

integer

Date of diagnosis
Beschreibung

Carotid artery stenting, date of diagnosis

Datentyp

date

12. Carotid artery surgery
Beschreibung

Carotid artery surgery

Datentyp

integer

Date of diagnosis
Beschreibung

Carotid artery surgery, date of diagnosis

Datentyp

date

13. Prior ischaemic stroke [>3 months]
Beschreibung

ischaemic stroke

Datentyp

integer

Date of diagnosis
Beschreibung

ischaemic stroke, date of diagnosis

Datentyp

date

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

Intermittent claudication

Datentyp

integer

Date of diagnosis
Beschreibung

Intermittent claudication, date of diagnosis

Datentyp

date

15. Peripheral arterial stenting
Beschreibung

Peripheral arterial stenting

Datentyp

integer

Date of diagnosis
Beschreibung

Peripheral arterial stenting, date of diagnosis

Datentyp

date

16. Peripheral artery surgery
Beschreibung

Peripheral artery surgery

Datentyp

integer

Date of diagnosis
Beschreibung

Peripheral artery surgery, date of diagnosis

Datentyp

date

17. Peripheral artery disease with amputation
Beschreibung

Peripheral artery disease with amputation

Datentyp

integer

Date of diagnosis
Beschreibung

Peripheral artery disease with amputation, date of diagnosis

Datentyp

date

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

Ankle brachial index decreased

Datentyp

integer

Date of dignosis
Beschreibung

Ankle brachial index decreased, date of dignosis

Datentyp

date

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Ähnliche Modelle

Medical Conditions GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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