The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial (STABILITY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00799903
First received: November 26, 2008
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Atherosclerosis
Drug: Darapladib
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Time to the first occurrence of any component of the composite of Major Adverse Cardiovascular Events [MACE: CV death (death due to a cardiovasacular cause), non-fatal myocardial infarction, non-fatal stroke] [ Time Frame: Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The composite measure of major coronary events that include the time to first occurrence of coronary heart disease death, non-fatal myocardial infarction or urgent coronary revascularization for myocardial ischemia [ Time Frame: Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years. ] [ Designated as safety issue: No ]
  • The composite measure of total coronary events that include the time to first occurrence of coronary heart disease death, non-fatal myocardial infarction, hospitalization for unstable angina , or any coronary revascularization procedure [ Time Frame: Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years. ] [ Designated as safety issue: No ]
  • The time to individual components of MACE [cardiovascular death, myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal) ] [ Time Frame: Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years. ] [ Designated as safety issue: No ]
  • The time to the first occurrence of any component of the composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke [ Time Frame: Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years. ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: Patients will remain in the study until a specified number of MACE events have occurred. It is anticipated that patients will be in the study about 3 years. ] [ Designated as safety issue: No ]

Enrollment: 15828
Study Start Date: December 2008
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Darapladib
Single daily oral tablet
Drug: Darapladib
Lp-PLA2 inhibitor administered in addition to standard therapy
Placebo Comparator: Placebo
Single daily oral tablet
Drug: Placebo
Placebo administered in addition to standard therapy

Detailed Description:

Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard therapy. Following the baseline visit, subjects will be expected to return for clinic visits at 1 month, 3 months, and every 6 months until the end of the study. Average time in the study for an individual subject is expected to be about 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799903

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Locations
United States, Alabama
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Birmingham, Alabama, United States, 35235
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Birmingham, Alabama, United States, 35294-0007
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Huntsville, Alabama, United States, 35801
United States, Alaska
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Anchorage, Alaska, United States, 99508
United States, Arkansas
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Little Rock, Arkansas, United States, 72204
United States, California
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Concord, California, United States, 94520
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Lomita, California, United States, 90717
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Los Angeles, California, United States, 90024
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Los Angeles, California, United States, 90036
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Madera, California, United States, 93637
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Oakland, California, United States, 94612
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Oakland, California, United States, 94611
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Poway, California, United States, 92064
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Sacramento, California, United States, 95819
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San Diego, California, United States, 92161
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San Ramon, California, United States, 94582
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Santa Ana, California, United States, 92705
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Spring Valley, California, United States, 91978
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Thousand Oaks, California, United States, 91360
United States, Colorado
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Colorada Springs, Colorado, United States, 80920
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Denver, Colorado, United States, 80218
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Golden, Colorado, United States, 80401
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Thornton, Colorado, United States, 80229
United States, Connecticut
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Bridgeport, Connecticut, United States, 06606
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Bridgeport, Connecticut, United States, 06610
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Hartford, Connecticut, United States, 06067
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Newark, Delaware, United States, 19718
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Atlantis, Florida, United States, 33462
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Gainesville, Florida, United States, 32610
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Hollywood, Florida, United States, 33023
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Jacksonville, Florida, United States, 32258
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Jacksonville, Florida, United States, 32216
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Jacksonville, Florida, United States, 32207
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Jacksonville Beach, Florida, United States, 32250
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Miami, Florida, United States, 33136
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Conyers, Georgia, United States, 30094
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Indianapolis, Indiana, United States, 46260
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Baltimore, Maryland, United States, 21209
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Oxon Hill, Maryland, United States, 20745
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Charleston, South Carolina, United States, 29401
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Charleston, South Carolina, United States, 29425-6240
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Rapid City, South Dakota, United States, 57701
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Bristol, Tennessee, United States, 37620
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Johnson City, Tennessee, United States, 37601
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Amarillo, Texas, United States, 79106
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Corpus Christi/Texas, Texas, United States, 78404
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Dallas, Texas, United States, 75231
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Dallas, Texas, United States, 75226
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Georgetown, Texas, United States, 78626
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Harker Heights, Texas, United States, 76548
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Houston, Texas, United States, 77081
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Houston, Texas, United States, 77030
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Plano, Texas, United States, 75024
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San Antonio, Texas, United States, 78217
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San Antonio, Texas, United States, 78244
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Victoria, Texas, United States, 77901
United States, Utah
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Draper, Utah, United States, 84020
United States, Virginia
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Burke, Virginia, United States, 22015
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Norfolk, Virginia, United States, 23502
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Richmond, Virginia, United States, 23294
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Winchester, Virginia, United States, 22601
United States, Washington
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Kirkland, Washington, United States, 98034
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Olympia, Washington, United States, 98502
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Renton, Washington, United States, 98057
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Seattle, Washington, United States, 98104
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Spokane, Washington, United States, 99204
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Spokane, Washington, United States, 99207
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Spokane, Washington, United States, 99208
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Tacoma, Washington, United States, 98405
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Walla Walla, Washington, United States, 99362
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Wenatchee, Washington, United States, 98801
United States, Wisconsin
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Wausau, Wisconsin, United States, 54401
Argentina
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Adrogue, Buenos Aires, Argentina, B1846DSK
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Bahia Blanca, Buenos Aires, Argentina, B8000FTD
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Caba, Buenos Aires, Argentina, C1124AAJ
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1405BCH
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1437JCP
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1125ABD
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Junin, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina, B1900AXI
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Mar del Plata, Buenos Aires, Argentina, B7600FZN
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Ramos Mejia, Buenos Aires, Argentina, B1704ETD
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Cordoba, Córdova, Argentina, X5000EPU
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Rosario, Santa Fe, Argentina, S2000CVD
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Buenos Aires, Argentina, 1425
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Corrientes, Argentina, W3400AMZ
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Corrientes, Argentina, W3400CLH
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Mendoza, Argentina, M5500CCG
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Santa Fe, Argentina, 3000
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Tucuman, Argentina, T4000ICL
Australia, Australian Capital Territory
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Garran, Australian Capital Territory, Australia, 2606
Australia, New South Wales
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Coffs Harbour, New South Wales, Australia, 2450
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Concord, New South Wales, Australia, 2139
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Gosford, New South Wales, Australia, 2250
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Liverpool, New South Wales, Australia, 2170
Australia, Queensland
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Auchenflower, Queensland, Australia, 4066
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Kippa Ring, Queensland, Australia, 4021
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Sherwood, Queensland, Australia, 4075
Australia, South Australia
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Bedford Park, South Australia, Australia, 5042
Australia, Victoria
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Ballarat, Victoria, Australia
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Caulfield South, Victoria, Australia, 3162
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Frankston, Victoria, Australia, 3199
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Malvern, Victoria, Australia, 3144
Australia, Western Australia
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Fremantle, Western Australia, Australia, 6160
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Joondalup, Western Australia, Australia, 6027
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Nedlands, Western Australia, Australia, 6009
Belgium
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Aalst, Belgium, 9300
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Antwerpen, Belgium, 2020
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Bonheiden, Belgium, 2820
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Bruxelles, Belgium, 1200
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Genk, Belgium, 3600
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Hasselt, Belgium, 3500
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La Louvière, Belgium, 7100
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Leuven, Belgium, 3000
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Liège, Belgium, 4000
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Roeselaere, Belgium, 8800
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Yvoir, Belgium, 5530
Brazil
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Salvador, Bahía, Brazil, 41810010
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Goiânia, Goiás, Brazil, 74605-050
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Belo Horizonte, Minas Gerais, Brazil, 30380090
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Belo Horizonte, Minas Gerais, Brazil, 30150-221.
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Curitiba, Paraná, Brazil, 80730150
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Pelotas, Rio Grande Do Sul, Brazil, 96015-290
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Porto Alegre, Rio Grande Do Sul, Brazil, 90880-480
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610000
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Natal, Rio Grande Du Norte, Brazil, 59020-100
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Campinas, São Paulo, Brazil, 13059740
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São José do Rio Preto, São Paulo, Brazil, 15015210
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São José do Rio Preto, São Paulo, Brazil, 15090-000
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Rio de Janeiro, Brazil, 20551-030
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São Paulo, Brazil, 05403-000
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São Paulo, Brazil, 04012-909
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São Paulo, Brazil, 04012180
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São Paulo, Brazil, 05403000
Bulgaria
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Dimitrovgrad, Bulgaria, 6400
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4003
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Ruse, Bulgaria, 7002
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Sofia, Bulgaria, 1606
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Sofia, Bulgaria, 1000
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Sofia, Bulgaria, 1233
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Sofia, Bulgaria, 1431
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Sofia, Bulgaria, 1527
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Veliko Tarnovo, Bulgaria, 5000
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
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Kelowna, British Columbia, Canada, V1Y 1E4
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New Westminister, British Columbia, Canada, V3L 3W4
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New Westminster, British Columbia, Canada, V3L 3W4
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Surrey, British Columbia, Canada, V3V 1N1
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Vancouver, British Columbia, Canada, V5Z 1M9
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Victoria, British Columbia, Canada, V8R 4R2
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Newfoundland and Labrador
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Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3A7
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Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
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Ajax, Ontario, Canada, L1S 7K8
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Brampton, Ontario, Canada, L6Z 4N5
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Hamilton, Ontario, Canada, L8L 2X2
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Kitchener, Ontario, Canada, N2M 5N6
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Mississauga, Ontario, Canada, L5B 2P7
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Oshawa, Ontario, Canada, L1J 2J9
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Ottawa, Ontario, Canada, K1Y 4W7
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Scarborough, Ontario, Canada, M1E 5E9
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Thornhill, Ontario, Canada, L4J 8L7
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Toronto, Ontario, Canada, M4G 3E8
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Toronto, Ontario, Canada, M5C 2T2
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Toronto, Ontario, Canada, M3H 5S4
Canada, Quebec
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Gatineau, Quebec, Canada, J8Y 6S8
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Greenfield Park, Quebec, Canada, J4V 2H1
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Levis, Quebec, Canada, G6V 4Z5
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Montreal, Quebec, Canada, H1T 3Y7
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Montreal, Quebec, Canada, H1T 1C8
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Quebec City, Quebec, Canada, G1J 1Z6
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Quebec City, Quebec, Canada, G1L 3L5
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Saint Charles-Borromee, Quebec, Canada, J6E 6J2
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Sherbrooke, Quebec, Canada, J1J 2E3
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Trois Rivières, Quebec, Canada, G8T 7A1
Chile
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Talcahuano, Región Del Biobio, Chile, 427 0918
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Santiago, Región Metro De Santiago, Chile, 8380456
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Santiago, Región Metro De Santiago, Chile, 750 0922
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Santiago, Región Metro De Santiago, Chile, 7571831
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Santiago, Región Metro De Santiago, Chile, 7500503
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Santiago, Región Metro De Santiago, Chile, 833 0074
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Santiago, Región Metro De Santiago, Chile, 8360160
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Viña del Mar, Valparaíso, Chile
China, Guangdong
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Guangzhou, Guangdong, China, 510080
China, Jiangsu
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Nanjing, Jiangsu, China, 210029
China, Shaanxi
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Xian, Shaanxi, China, 710061
China, Shandong
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Jinan, Shandong, China, 250012
China, Zhejiang
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Hang Zhou, Zhejiang, China, 310003
China
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Beijing, China, 100044
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Beijing, China, 100730
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Beijing, China, 100034
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Beijing, China, 100853
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Guangzhou, China, 510100
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Haerbin, China, 150001
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Shanghai, China, 200032
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Shanghai, China, 200040
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Shanghai, China, 200233
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Shanghai, China, 200127
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Wuhan, China, 430022
Czech Republic
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Caslav, Czech Republic, 286 01
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Chomutov, Czech Republic, 430 02
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Chrudim, Czech Republic, 537 27
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Jihlava, Czech Republic, 586 33
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Kladno, Czech Republic, 272 80
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Kolin, Czech Republic, 280 00
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Kromeriz, Czech Republic, 767 55
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Milevsko, Czech Republic, 399 01
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Pisek, Czech Republic, 397 01
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Praha 2, Czech Republic, 128 08
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Pribram, Czech Republic, 261 26
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Slany, Czech Republic
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Svitavy, Czech Republic, 568 25
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Tabor, Czech Republic, 390 03
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Usti nad Orlici, Czech Republic, 562 18
Denmark
GSK Investigational Site
Aarhus, Denmark, DK-8000
GSK Investigational Site
Esbjerg, Denmark, 6700
GSK Investigational Site
Koebenhavn OE, Denmark, 2100
GSK Investigational Site
Silkeborg, Denmark, 8600
Estonia
GSK Investigational Site
Tallinn, Estonia, 13419
GSK Investigational Site
Tallinn, Estonia, 1162
GSK Investigational Site
Tartu, Estonia, 51014
France
GSK Investigational Site
Aix en Provence cedex 1, France, 13616
GSK Investigational Site
Avignon, France, 84082
GSK Investigational Site
Besançon Cedex, France, 25030
GSK Investigational Site
Bron Cedex, France, 69677
GSK Investigational Site
Créteil, France, 94010
GSK Investigational Site
Dijon, France, 21079
GSK Investigational Site
Lille Cedex, France, 59037
GSK Investigational Site
Marseille cedex 5, France, 13385
GSK Investigational Site
Metz Cedex 03, France, 57085
GSK Investigational Site
Nantes Cedex 1, France, 44093
GSK Investigational Site
Narbonne Cedex, France, 11108
GSK Investigational Site
Nimes, France, 30000
GSK Investigational Site
Paris, France, 75010
GSK Investigational Site
Paris, France, 75015
GSK Investigational Site
Paris Cedex 13, France, 75651
GSK Investigational Site
Paris Cedex 18, France, 75877
GSK Investigational Site
Pessac cedex, France, 33604
GSK Investigational Site
Roubaix, France, 59056
GSK Investigational Site
Strasbourg cedex, France, 67091
GSK Investigational Site
Toulouse Cedex 09, France, 31059
GSK Investigational Site
Tourcoing, France, 59208
Germany
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
GSK Investigational Site
Gueglingen, Baden-Wuerttemberg, Germany, 74363
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
GSK Investigational Site
Aschaffenburg, Bayern, Germany, 63739
GSK Investigational Site
Haag, Bayern, Germany, 83527
GSK Investigational Site
Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
GSK Investigational Site
Kuenzing, Bayern, Germany, 94550
GSK Investigational Site
Muehldorf, Bayern, Germany, 84453
GSK Investigational Site
Muenchen, Bayern, Germany, 80336
GSK Investigational Site
Sulzbach-Rosenberg, Bayern, Germany, 92237
GSK Investigational Site
Wallerfing, Bayern, Germany, 94574
GSK Investigational Site
Bernau, Brandenburg, Germany, 16321
GSK Investigational Site
Frankfurt/M., Hessen, Germany, 60594
GSK Investigational Site
Kelkheim, Hessen, Germany, 65779
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Weyhe-Leeste, Niedersachsen, Germany, 28844
GSK Investigational Site
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
GSK Investigational Site
Dorsten, Nordrhein-Westfalen, Germany, 46282
GSK Investigational Site
Eschweiler, Nordrhein-Westfalen, Germany, 52249
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
GSK Investigational Site
Herford, Nordrhein-Westfalen, Germany, 32049
GSK Investigational Site
Lienen-Kattenvenne, Nordrhein-Westfalen, Germany, 49536
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58455
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
GSK Investigational Site
Delitzsch, Sachsen, Germany, 04509
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Leipzg, Sachsen, Germany, 04109
GSK Investigational Site
Leipzig, Sachsen, Germany, 04329
GSK Investigational Site
Leipzig, Sachsen, Germany, 04315
GSK Investigational Site
Schmiedeberg, Sachsen, Germany, 01762
GSK Investigational Site
Berlin, Germany, 13405
GSK Investigational Site
Berlin, Germany, 13086
GSK Investigational Site
Berlin, Germany, 13347
GSK Investigational Site
Berlin, Germany, 13353
GSK Investigational Site
Berlin, Germany, 13055
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 10559
GSK Investigational Site
Berlin, Germany, 10367
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Berlin, Germany, 12157
GSK Investigational Site
Hamburg, Germany, 22041
Greece
GSK Investigational Site
Agia Varvara, Athens, Greece, 123 51
GSK Investigational Site
Alexandroupolis, Greece, 68100
GSK Investigational Site
Athens, Greece, 124 62
GSK Investigational Site
Athens, Greece, 176 74
GSK Investigational Site
Athens, Greece, 11527
GSK Investigational Site
Chalkida, Greece, 341 00
GSK Investigational Site
Ioannina, Greece, 45500
GSK Investigational Site
Magoula, Elefsina, Greece, 192 00
GSK Investigational Site
Patras, Greece, 26 500
GSK Investigational Site
Thessaloniki, Greece, 546 42
GSK Investigational Site
Voula / Athens, Greece, 166 73
Hong Kong
GSK Investigational Site
Hong Kong, Hong Kong
GSK Investigational Site
Shatin, New Territories, Hong Kong
Hungary
GSK Investigational Site
Berettyóújfalu, Hungary
GSK Investigational Site
Budapest, Hungary, 1032
GSK Investigational Site
Budapest, Hungary, 1096
GSK Investigational Site
Budapest, Hungary, 1033
GSK Investigational Site
Esztergom, Hungary
GSK Investigational Site
Gyula, Hungary, 5700
GSK Investigational Site
Komárom, Hungary, 2921
GSK Investigational Site
Mosonmagyaróvár, Hungary, 9200
GSK Investigational Site
Szikszó, Hungary
GSK Investigational Site
Szolnok, Hungary, 5004
GSK Investigational Site
Székesfehérvár, Hungary, 8000
GSK Investigational Site
Sátoraljaújhely, Hungary, 3980
India
GSK Investigational Site
Ahmedabad, India, 380060
GSK Investigational Site
Bangalore, India, 560 099
GSK Investigational Site
Bangalore, India, 560034
GSK Investigational Site
Cochin, India, 683572
GSK Investigational Site
Jaipur, India, 302001
GSK Investigational Site
Jaipur, India, 302017
GSK Investigational Site
Mysore, India, 570020
GSK Investigational Site
New Delhi, India, 110060
GSK Investigational Site
Patiala, India, 147001
GSK Investigational Site
Pune, India, 411030
GSK Investigational Site
Pune, India, 411004
GSK Investigational Site
Saket,Delhi, India, 110017
GSK Investigational Site
Vadodara, India, 390015
GSK Investigational Site
Vijayawada, India, 520008
Italy
GSK Investigational Site
Chieti, Abruzzo, Italy, 66013
GSK Investigational Site
Napoli, Campania, Italy, 80131
GSK Investigational Site
Carpi, Emilia-Romagna, Italy, 41012
GSK Investigational Site
Cona (Ferrara), Emilia-Romagna, Italy, 44124
GSK Investigational Site
Parma, Emilia-Romagna, Italy, 43100
GSK Investigational Site
Roma, Lazio, Italy, 00135
GSK Investigational Site
Milano, Lombardia, Italy, 20162
GSK Investigational Site
Ascoli Piceno, Marche, Italy, 63100
GSK Investigational Site
Cuneo, Piemonte, Italy, 12100
GSK Investigational Site
Novara, Piemonte, Italy, 28100
GSK Investigational Site
Pisa, Toscana, Italy, 56126
GSK Investigational Site
Treviso, Veneto, Italy, 31100
Japan
GSK Investigational Site
Aichi, Japan, 487-0013
GSK Investigational Site
Chiba, Japan, 270-2251
GSK Investigational Site
Fukuoka, Japan, 811-3195
GSK Investigational Site
Fukuoka, Japan, 819-1104
GSK Investigational Site
Fukuoka, Japan, 802-8555
GSK Investigational Site
Hokkaido, Japan, 063-0005
GSK Investigational Site
Hokkaido, Japan, 065-0033
GSK Investigational Site
Kagoshima, Japan, 892-0853
GSK Investigational Site
Kanagawa, Japan, 247-8533
GSK Investigational Site
Kanagawa, Japan, 240-0116
GSK Investigational Site
Kyoto, Japan, 611-0042
GSK Investigational Site
Nagano, Japan, 386-8610
GSK Investigational Site
Nagasaki, Japan, 859-3615
GSK Investigational Site
Nagasaki, Japan, 856-8562
GSK Investigational Site
Oita, Japan, 870-1133
GSK Investigational Site
Osaka, Japan, 574-0074
GSK Investigational Site
Shiga, Japan, 520-2192
GSK Investigational Site
Shizuoka, Japan, 411-8611
GSK Investigational Site
Tokyo, Japan, 141-0001
Korea, Republic of
GSK Investigational Site
Cheongju, Korea, Republic of, 361-711
GSK Investigational Site
Dae-Gu, Korea, Republic of, 700-721
GSK Investigational Site
Gangnam-gu, Seoul, Korea, Republic of, 135-710
GSK Investigational Site
Gwangju, Korea, Republic of, 501-757
GSK Investigational Site
jeonju-si, Jeollabuk-Do, Korea, Republic of, 561-712
GSK Investigational Site
Seo-gu Busan, Korea, Republic of, 602-739
GSK Investigational Site
Seongnam-si Gyeonggi-do, Korea, Republic of, 463-707
GSK Investigational Site
Seoul, Korea, Republic of, 137-701
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
GSK Investigational Site
Seoul, Korea, Republic of, 110-744
GSK Investigational Site
Seoul, Korea, Republic of, 130-702
GSK Investigational Site
Seoul, Korea, Republic of, 136-705
GSK Investigational Site
Seoul, Korea, Republic of, 143-729
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Uijeongbu-si Kyonggi-do, Korea, Republic of, 480-717
Mexico
GSK Investigational Site
Monterrey NL, Nuevo León, Mexico, 64718
GSK Investigational Site
Durango, Mexico, 34080
GSK Investigational Site
Mexico, Mexico, 10700
GSK Investigational Site
México D.F,, Mexico, 07760
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
GSK Investigational Site
Beverwijk, Netherlands, 1942 LE
GSK Investigational Site
Den Haag, Netherlands, 2597 AX
GSK Investigational Site
Doetinchem, Netherlands, 7009 BL
GSK Investigational Site
Eindhoven, Netherlands, 5623 EJ
GSK Investigational Site
Enschede, Netherlands, 7513 ER
GSK Investigational Site
Goes, Netherlands, 4462 RA
GSK Investigational Site
Harderwijk, Netherlands, 3844 DG
GSK Investigational Site
Hoofddorp, Netherlands, 2134 TM
GSK Investigational Site
Leeuwarden, Netherlands, 8934 AD
GSK Investigational Site
Rotterdam, Netherlands, 3079 DZ
GSK Investigational Site
Sittard-geleen, Netherlands, 6162 BG
GSK Investigational Site
Sneek, Netherlands, 8601 ZK
GSK Investigational Site
Tiel, Netherlands, 4002 WP
New Zealand
GSK Investigational Site
Christchurch, New Zealand
GSK Investigational Site
Dunedin, New Zealand
GSK Investigational Site
Grafton, Auckland, New Zealand, 1030
GSK Investigational Site
Hamilton, New Zealand, 3204
GSK Investigational Site
Lower Hutt, New Zealand
GSK Investigational Site
Nelson, New Zealand
GSK Investigational Site
Otahuhu, Auckland, New Zealand, 1640
GSK Investigational Site
Palmerston North, New Zealand, 4410
GSK Investigational Site
Takapuna, Auckland, New Zealand, 0622
GSK Investigational Site
Tauranga, New Zealand, 3112
GSK Investigational Site
Timaru, New Zealand, 7910
GSK Investigational Site
Whangarei, New Zealand
Norway
GSK Investigational Site
Bergen, Norway, 5021
GSK Investigational Site
Moss, Norway, 1501
GSK Investigational Site
Oslo, Norway, 0160
GSK Investigational Site
Oslo, Norway, 0407
Pakistan
GSK Investigational Site
Karachi, Pakistan, 75510
GSK Investigational Site
Karachi, Pakistan, 75950
GSK Investigational Site
Korangi / Karachi, Pakistan
GSK Investigational Site
Lahore, Pakistan, 54000
GSK Investigational Site
Lahore, Pakistan
GSK Investigational Site
Multan, Pakistan, 60000
GSK Investigational Site
Rawalpindi Cantt, Pakistan, 46000
Peru
GSK Investigational Site
Jesus Maria, Lima, Peru, Lima 11
GSK Investigational Site
Callao, Peru, Callao 2
GSK Investigational Site
Lima, Peru, Lima 11
Philippines
GSK Investigational Site
Ermita, Manila, Philippines, 1000
GSK Investigational Site
Manila, Philippines, 1100
GSK Investigational Site
Manila, Philippines, 1000
GSK Investigational Site
Quezon City, Philippines
GSK Investigational Site
Quezon City, Philippines, 1113
GSK Investigational Site
Quezon City, Philippines, 1109
GSK Investigational Site
San Juan, Philippines, 1502
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-079
GSK Investigational Site
Bydgoszcz, Poland, 85-435
GSK Investigational Site
Gdynia, Poland, 81-423
GSK Investigational Site
Kowanowko, Poland
GSK Investigational Site
Krakow, Poland, 31-202
GSK Investigational Site
Mielec, Poland, 39-300
GSK Investigational Site
Ostrow Wielkopolski, Poland, 63-400
GSK Investigational Site
Plonsk, Poland, 09 - 100
GSK Investigational Site
Radom, Poland, 26-617
GSK Investigational Site
Ruda Slaska, Poland, 41-706
GSK Investigational Site
Siemianowice Slaskie, Poland, 41-100
GSK Investigational Site
Skierniewice, Poland
GSK Investigational Site
Torun, Poland, 87-100
GSK Investigational Site
Tychy, Poland, 43-100
GSK Investigational Site
Warszawa, Poland, 04-073
GSK Investigational Site
Warszawa, Poland, 03-285
GSK Investigational Site
Wloclawek, Poland, 87-800
GSK Investigational Site
Wroclaw, Poland, 50-349
Romania
GSK Investigational Site
Bucharest, Romania, 041915
GSK Investigational Site
Bucharest, Romania, 011601
GSK Investigational Site
Bucharest, Romania, 022328
GSK Investigational Site
Bucharest, Romania, 011461
GSK Investigational Site
Bucharest, Romania, 050098
GSK Investigational Site
Bucharest, Romania, 011794
GSK Investigational Site
Bucharest, Romania, 042122
GSK Investigational Site
Deva, Romania, 330084
GSK Investigational Site
Galati, Romania, 800087
GSK Investigational Site
Targu Mures, Romania, 540136
Russian Federation
GSK Investigational Site
Ekaterinburg, Russian Federation, 620144
GSK Investigational Site
Ekaterinburg, Russian Federation, 620109
GSK Investigational Site
Kemerovo, Russian Federation, 650055
GSK Investigational Site
Kemerovo, Russian Federation, 650002
GSK Investigational Site
Moscow, Russian Federation, 121 552
GSK Investigational Site
Moscow, Russian Federation, 121552
GSK Investigational Site
Moscow, Russian Federation, 119620
GSK Investigational Site
Moscow, Russian Federation, 111539
GSK Investigational Site
Moscow, Russian Federation, 117292
GSK Investigational Site
Moscow, Russian Federation, 111020
GSK Investigational Site
Novosibirsk, Russian Federation, 630047
GSK Investigational Site
Novosibirsk, Russian Federation, 630003
GSK Investigational Site
Novosibirsk, Russian Federation, 630008
GSK Investigational Site
Ryazan, Russian Federation, 390026
GSK Investigational Site
S.-Petresburg, Russian Federation, 195067
GSK Investigational Site
St Pertersburg, Russian Federation, 196247
GSK Investigational Site
St'Petersburg, Russian Federation, 194156
GSK Investigational Site
St-Petersburg, Russian Federation, 193312
GSK Investigational Site
St-Petersburg, Russian Federation, 195067
GSK Investigational Site
St-Petersburg, Russian Federation, 199106
GSK Investigational Site
Yekaterinburg, Russian Federation
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 813 69
GSK Investigational Site
Bratislava, Slovakia, 833 05
GSK Investigational Site
Kosice, Slovakia, 040 22
GSK Investigational Site
Nitra, Slovakia, 949 01
South Africa
GSK Investigational Site
Parktown, Gauteng, South Africa, 2193
GSK Investigational Site
Bellville, South Africa, 7531
GSK Investigational Site
Bloemfontein, South Africa, 9301
GSK Investigational Site
Kempton Park, South Africa, 1619
GSK Investigational Site
Kuils River, South Africa, 7580
GSK Investigational Site
Moreletapark, South Africa, 0181
GSK Investigational Site
Olivedale, South Africa, 2188
GSK Investigational Site
Paarl, South Africa, 7646
GSK Investigational Site
Parktown West, South Africa, 2193
GSK Investigational Site
Parow, South Africa, 7505
GSK Investigational Site
Pinelands, South Africa, 7405
GSK Investigational Site
Somerset West, South Africa, 7130
GSK Investigational Site
Soweto, South Africa, 2013
GSK Investigational Site
Umhlanga, South Africa, 4319
Spain
GSK Investigational Site
Alicante, Spain, 03114
GSK Investigational Site
Granada, Spain, 18012
GSK Investigational Site
Jerez de la Frontera, Spain, 11407
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Madrid, Spain, 28034
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Madrid, Spain, 28041
GSK Investigational Site
Madrid, Spain, 28031
GSK Investigational Site
Madrid, Spain, 28029
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Malaga, Spain, 29010
GSK Investigational Site
Marid, Spain, 28040
GSK Investigational Site
Oviedo, Spain, 33006
GSK Investigational Site
Pozuelo de Alarcón/Madrid, Spain, 28223
GSK Investigational Site
San Juan (Alicante), Spain, 03550
GSK Investigational Site
San Sebastián, Spain, 20014
GSK Investigational Site
San Sebastián de los Reyes/Madrid, Spain
GSK Investigational Site
Santander, Spain, 39008
GSK Investigational Site
Sevilla, Spain, 41071
GSK Investigational Site
Sta Coloma de Gramanet (Barcelona), Spain, 08923
GSK Investigational Site
Valdemoro/Madrid, Spain, 28340
Sweden
GSK Investigational Site
Eksjö, Sweden, SE-575 36
GSK Investigational Site
Göteborg, Sweden, SE-416 85
GSK Investigational Site
Göteborg, Sweden, SE-413 45
GSK Investigational Site
Linköping, Sweden, SE-581 85
GSK Investigational Site
Lund, Sweden, SE-222 21
GSK Investigational Site
Malmö, Sweden, SE-205 02
GSK Investigational Site
Stockholm, Sweden, SE-111 35
GSK Investigational Site
Stockholm, Sweden, SE-111 57
GSK Investigational Site
Stockholm, Sweden, SE-182 88
GSK Investigational Site
Umeå, Sweden, SE-901 85
GSK Investigational Site
Uppsala, Sweden, SE-751 85
GSK Investigational Site
Västervik, Sweden, SE-593 81
GSK Investigational Site
Västerås, Sweden, SE-721 89
GSK Investigational Site
Östersund, Sweden, SE-831 83
Taiwan
GSK Investigational Site
Changhua, Taiwan, 500
GSK Investigational Site
Taichung, Taiwan, 407
GSK Investigational Site
Tainan, Taiwan, 704
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taipei, Taiwan, 112
GSK Investigational Site
Taipei City, Taiwan, 104
Thailand
GSK Investigational Site
Bangkok, Thailand, 10700
GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Bangkok, Thailand, 10330
GSK Investigational Site
Chiangmai, Thailand, 50200
Ukraine
GSK Investigational Site
Donetsk, Ukraine, 83045
GSK Investigational Site
Kharkiv, Ukraine, 61002
GSK Investigational Site
Kharkiv, Ukraine, 61176
GSK Investigational Site
Kharkiv, Ukraine, 61018
GSK Investigational Site
Kharkiv, Ukraine, 61037
GSK Investigational Site
Kyiv, Ukraine, 03680
GSK Investigational Site
Kyiv, Ukraine, 02660
GSK Investigational Site
Kyiv, Ukraine, 04114
GSK Investigational Site
Lviv, Ukraine, 79044
GSK Investigational Site
Odesa, Ukraine, 65025
GSK Investigational Site
Odesa, Ukraine, 65114
GSK Investigational Site
Vinnytsia, Ukraine, 21029
GSK Investigational Site
Zaporizhzhia, Ukraine, 69118
United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G11 6NT
GSK Investigational Site
Motherwell, Lanarkshire, United Kingdom, ML1 3JX
GSK Investigational Site
Chelsea, London, United Kingdom, SW3 6NP
GSK Investigational Site
Liverpool, Merseyside, United Kingdom
GSK Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ
GSK Investigational Site
Chertsey, Surrey, United Kingdom, KT16 0PZ
GSK Investigational Site
Chichester, Sussex West, United Kingdom, PO19 4SE
GSK Investigational Site
Barnet, United Kingdom, EN5 3DJ
GSK Investigational Site
Coatbridge, United Kingdom, ML5 3AP
GSK Investigational Site
Cottingham, United Kingdom, HU16 5JQ
GSK Investigational Site
Cumbernauld, United Kingdom, G67 1BJ
GSK Investigational Site
Hamilton, United Kingdom, ML3 8AA
GSK Investigational Site
Hertfordshire, United Kingdom
GSK Investigational Site
Liverpool, United Kingdom, L7 8XP
GSK Investigational Site
Newcastle-upon-Tyne, United Kingdom, NE7 7DN
GSK Investigational Site
Paisley, United Kingdom, PA2 9PN
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00799903     History of Changes
Other Study ID Numbers: 100601
Study First Received: November 26, 2008
Last Updated: May 29, 2014
Health Authority: Estonia: State Agency of Medicines
Chile: Institutional Review Board
Brazil: Institutional Review Board
Peru: Institutional Review Board
Czech Republic: Státní ústav pro kontrolu léčiv, Oddělení klinického hodnocení
Spain: Agencia Española del Medicamento y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Comitato Etico Unico per la Provincia di Parma
Bulgaria: The Bulgarian Drug Agency
Argentina: Ministry of Health - A.N.M.A.T
Belgium: Agence Fédérale des Médicaments et des Produits de la Santé
Romania: Agentia Nationala a Medicamentului
Pakistan: Drug Controller R&D Ministry of Health
Norway: Statens Legemiddelverk
Denmark: Lægemiddelstyrelsen
Philippines: Bureau of Food and Drugs
Hungary: Országos Gyógyszerészeti Intézet
South Africa: Medicines Control Council
Slovak Republic: Štátny ústav pre kontrolu liečiv
Poland: URZ.D REJESTRACJI PRODUKTÓW LECZNICZYCH, WYROBÓW MEDYCZNYCH I PRODUKTÓW BIOBÓJCZYCH,CEBK
Canada: Health Canada
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
France: Agence Française de Sécurité Sanitaire des Produits de Santé
Netherlands: De Centrale Commissie Mensgebonden Onderzoek
China: Food and Drug Administration
South Korea: Food and Drug Administration
United States: Food and Drug Administration
Sweden: Läkemedelsverket
Greece: National Drug Organisation

Keywords provided by GlaxoSmithKline:
heart disease
Lp-PLA2 inhibitor
cardiovascular disease
coronary heart disease
CV risk
Atherosclerosis

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Plaque, Atherosclerotic
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Darapladib
Phospholipase A2 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014