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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00799903




Registration number
NCT00799903
Ethics application status
Date submitted
26/11/2008
Date registered
1/12/2008
Date last updated
10/08/2017

Titles & IDs
Public title
The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial
Scientific 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)
Secondary ID [1] 0 0
100601
Universal Trial Number (UTN)
Trial acronym
STABILITY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Darapladib
Treatment: Drugs - Placebo

Experimental: Darapladib - Single daily oral tablet

Placebo Comparator: Placebo - Single daily oral tablet


Treatment: Drugs: Darapladib
Lp-PLA2 inhibitor administered in addition to standard therapy

Treatment: Drugs: Placebo
Placebo administered in addition to standard therapy

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events - CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).
Timepoint [1] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Secondary outcome [1] 0 0
Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events (Coronary Heart Disease [CHD] Death, Non-fatal MI, or Urgent Coronary Revascularization [CR] for MI) During the Time Period for Follow-up (FU) of CV Events - CHD death=occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g.,silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent CR for MI=ischemic discomfort at rest that prompted CR (percutaneous coronary intervention [PCI: any attempt at CR even if not successful] or coronary artery bypass graft) during the same hospitalization or resulted in hospital transfer for the purpose of CR.
Timepoint [1] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Secondary outcome [2] 0 0
Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During Time Period for FU of CV Events - CHD death, acute MI, and prior MI are defined in the previous secondary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort is found not to be caused by myocardial ischemia.
Timepoint [2] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Secondary outcome [3] 0 0
Number of Participants With CV Death During the Time Period for Follow-up of CV Events - CV death is defined as a death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.
Timepoint [3] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Secondary outcome [4] 0 0
Number of Participants With First Occurrence of MI (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events - Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.
Timepoint [4] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Secondary outcome [5] 0 0
Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events - Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).
Timepoint [5] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Secondary outcome [6] 0 0
Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Non-fatal Stroke During the Time Period for Follow-up of CV Events - Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).
Timepoint [6] 0 0
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Secondary outcome [7] 0 0
Number of Participants With All-cause Mortality During the Time Period for Vital Status - The number of participants with all-cause mortality was assessed.
Timepoint [7] 0 0
From randomization until death or study completion (up to 4.49 years/average of 3.65 years)

Eligibility
Key inclusion criteria
- Men or women at least 18 years old. Women must be post-menopausal or using a highly
effective method for avoidance of pregnancy.

- Current treatment with statin therapy unless the study doctor determines statins are
not appropriate for the subject.

- Chronic coronary heart disease

- At least one of the following:

- At least 60 years old

- Diabetes requiring treatment with medication

- Low HDL cholesterol ("good cholesterol")

- Currently smoke cigarettes or stopped smoking within the past 3 months

- Diagnosed mild or moderate reduction in kidney function

- Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months
prior to study entry) OR peripheral arterial disease.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Planned coronary revascularization (such as stent placement or heart bypass) or any
other major surgical procedure.

- Liver disease

- Severe reduction in kidney function OR removal of a kidney OR kidney transplant

- Severe heart failure

- Blood pressure higher than normal despite lifestyle changes and treatment with
medications

- Any life-threatening disease expected to result in death within the next 2 years
(other than heart disease)

- Severe asthma that is poorly controlled with medication

- Pregnant (Note: A pregnancy test will be performed on all non-sterile women prior to
study entry)

- Previous severe allergic response to food, drink, insect stings, etc.

- Drug or alcohol abuse within the past 6 months OR mental/psychological impairment that
may prevent the subject from complying with study procedures or understanding the goal
and potential risks of participating in the study.

- Certain medications that may interfere with the study medication (these will be
identified by the study doctor)

- Participation in a study of an investigational medication within the past 30 days

- Current participation in a study of an investigational device

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment hospital [2] 0 0
GSK Investigational Site - Coffs Harbour
Recruitment hospital [3] 0 0
GSK Investigational Site - Concord
Recruitment hospital [4] 0 0
GSK Investigational Site - Gosford
Recruitment hospital [5] 0 0
GSK Investigational Site - Liverpool
Recruitment hospital [6] 0 0
GSK Investigational Site - Auchenflower
Recruitment hospital [7] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [8] 0 0
GSK Investigational Site - Sherwood
Recruitment hospital [9] 0 0
GSK Investigational Site - Bedford Park
Recruitment hospital [10] 0 0
GSK Investigational Site - Ballarat
Recruitment hospital [11] 0 0
GSK Investigational Site - Caulfield South
Recruitment hospital [12] 0 0
GSK Investigational Site - Frankston
Recruitment hospital [13] 0 0
GSK Investigational Site - Malvern
Recruitment hospital [14] 0 0
GSK Investigational Site - Fremantle
Recruitment hospital [15] 0 0
GSK Investigational Site - Joondalup
Recruitment hospital [16] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
2250 - Gosford
Recruitment postcode(s) [5] 0 0
2170 - Liverpool
Recruitment postcode(s) [6] 0 0
4066 - Auchenflower
Recruitment postcode(s) [7] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [8] 0 0
4075 - Sherwood
Recruitment postcode(s) [9] 0 0
5042 - Bedford Park
Recruitment postcode(s) [10] 0 0
- Ballarat
Recruitment postcode(s) [11] 0 0
3162 - Caulfield South
Recruitment postcode(s) [12] 0 0
3199 - Frankston
Recruitment postcode(s) [13] 0 0
3144 - Malvern
Recruitment postcode(s) [14] 0 0
6160 - Fremantle
Recruitment postcode(s) [15] 0 0
6027 - Joondalup
Recruitment postcode(s) [16] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Alaska
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Arkansas
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California
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Colorado
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Connecticut
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Delaware
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nebraska
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Nevada
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New York
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Leuven
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Liège
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Belgium
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Roeselaere
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Belgium
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Yvoir
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Brazil
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Bahía
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Goiás
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Minas Gerais
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Brazil
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Paraná
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Brazil
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Rio Grande Do Sul
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Brazil
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Rio Grande Du Norte
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Brazil
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São Paulo
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Brazil
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Rio de Janeiro
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Bulgaria
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Dimitrovgrad
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Ruse
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Bulgaria
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Sofia
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Bulgaria
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Veliko Tarnovo
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Newfoundland and Labrador
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Canada
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Nova Scotia
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Canada
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Ontario
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Quebec
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Chile
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Región Del Biobio
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Chile
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Región Metro De Santiago
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Chile
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Valparaíso
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China
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Guangdong
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China
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Jiangsu
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China
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Shaanxi
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China
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Shandong
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China
State/province [86] 0 0
Zhejiang
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China
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Beijing
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China
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Guangzhou
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China
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Haerbin
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China
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Shanghai
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China
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Wuhan
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Czechia
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Caslav
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Czechia
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Chomutov
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Czechia
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Chrudim
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Czechia
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Jihlava
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Czechia
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Kladno
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Czechia
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Kolin
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Kromeriz
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Milevsko
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Czechia
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Pisek
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Czechia
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Praha 2
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Czechia
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Pribram
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Czechia
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Slany
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Svitavy
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Czechia
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Tabor
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Czechia
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Usti nad Orlici
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Denmark
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Aarhus
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Denmark
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Esbjerg
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Denmark
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Koebenhavn OE
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Denmark
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Silkeborg
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Estonia
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Tallinn
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Estonia
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Tartu
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France
State/province [113] 0 0
Aix en Provence cedex 1
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France
State/province [114] 0 0
Avignon
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France
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Besançon Cedex
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France
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Bron Cedex
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France
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Créteil
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France
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Dijon
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France
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Lille Cedex
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France
State/province [120] 0 0
Marseille cedex 5
Country [121] 0 0
France
State/province [121] 0 0
Metz Cedex 03
Country [122] 0 0
France
State/province [122] 0 0
Nantes Cedex 1
Country [123] 0 0
France
State/province [123] 0 0
Narbonne Cedex
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France
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Nimes
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France
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Paris Cedex 13
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France
State/province [126] 0 0
Paris Cedex 18
Country [127] 0 0
France
State/province [127] 0 0
Paris
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France
State/province [128] 0 0
Pessac cedex
Country [129] 0 0
France
State/province [129] 0 0
Roubaix
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France
State/province [130] 0 0
Strasbourg cedex
Country [131] 0 0
France
State/province [131] 0 0
Toulouse Cedex 09
Country [132] 0 0
France
State/province [132] 0 0
Tourcoing
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Germany
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Brandenburg
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
Country [139] 0 0
Germany
State/province [139] 0 0
Rheinland-Pfalz
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Germany
State/province [140] 0 0
Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Berlin
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Germany
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Hamburg
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Greece
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Agia Varvara, Athens
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Greece
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Alexandroupolis
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Greece
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Athens
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Greece
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Chalkida
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Greece
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Ioannina
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Greece
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Magoula, Elefsina
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Greece
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Patras
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Greece
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Thessaloniki
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Greece
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Voula / Athens
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Hong Kong
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Hong Kong
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Hong Kong
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Shatin, New Territories
Country [155] 0 0
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Paisley

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will test whether darapladib can safely lower the chances of having a
cardiovascular event (such as a heart attack or stroke) in people with coronary heart
disease.
Trial website
https://clinicaltrials.gov/show/NCT00799903
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications