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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00799903
Ethics application status
Date submitted
26/11/2008
Date registered
1/12/2008

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
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
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
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
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
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
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
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
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
Sex
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
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/10/2013
Sample size
Target
Accrual to date
Final
15828
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
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GSK Investigational Site - Liverpool
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GSK Investigational Site - Auchenflower
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GSK Investigational Site - Kippa Ring
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GSK Investigational Site - Sherwood
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GSK Investigational Site - Bedford Park
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GSK Investigational Site - Ballarat
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GSK Investigational Site - Caulfield South
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GSK Investigational Site - Frankston
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GSK Investigational Site - Malvern
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GSK Investigational Site - Fremantle
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GSK Investigational Site - Joondalup
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GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2606 - Garran
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2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2139 - Concord
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2250 - Gosford
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2170 - Liverpool
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4066 - Auchenflower
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4021 - Kippa Ring
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4075 - Sherwood
Recruitment postcode(s) [9] 0 0
5042 - Bedford Park
Recruitment postcode(s) [10] 0 0
- Ballarat
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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
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6027 - Joondalup
Recruitment postcode(s) [16] 0 0
6009 - Nedlands
Recruitment outside Australia
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Japan
State/province [189] 0 0
Kagoshima
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Japan
State/province [190] 0 0
Kanagawa
Country [191] 0 0
Japan
State/province [191] 0 0
Kyoto
Country [192] 0 0
Japan
State/province [192] 0 0
Nagano
Country [193] 0 0
Japan
State/province [193] 0 0
Nagasaki
Country [194] 0 0
Japan
State/province [194] 0 0
Oita
Country [195] 0 0
Japan
State/province [195] 0 0
Osaka
Country [196] 0 0
Japan
State/province [196] 0 0
Shiga
Country [197] 0 0
Japan
State/province [197] 0 0
Shizuoka
Country [198] 0 0
Japan
State/province [198] 0 0
Tokyo
Country [199] 0 0
Korea, Republic of
State/province [199] 0 0
Cheongju
Country [200] 0 0
Korea, Republic of
State/province [200] 0 0
Dae-Gu
Country [201] 0 0
Korea, Republic of
State/province [201] 0 0
Gangnam-gu, Seoul
Country [202] 0 0
Korea, Republic of
State/province [202] 0 0
Gwangju
Country [203] 0 0
Korea, Republic of
State/province [203] 0 0
jeonju-si, Jeollabuk-Do
Country [204] 0 0
Korea, Republic of
State/province [204] 0 0
Seo-gu Busan
Country [205] 0 0
Korea, Republic of
State/province [205] 0 0
Seongnam-si Gyeonggi-do
Country [206] 0 0
Korea, Republic of
State/province [206] 0 0
Seoul
Country [207] 0 0
Korea, Republic of
State/province [207] 0 0
Uijeongbu-si Kyonggi-do
Country [208] 0 0
Mexico
State/province [208] 0 0
Nuevo León
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Mexico
State/province [209] 0 0
Durango
Country [210] 0 0
Mexico
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Mexico
Country [211] 0 0
Mexico
State/province [211] 0 0
México D.F,
Country [212] 0 0
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State/province [212] 0 0
Amsterdam
Country [213] 0 0
Netherlands
State/province [213] 0 0
Beverwijk
Country [214] 0 0
Netherlands
State/province [214] 0 0
Den Haag
Country [215] 0 0
Netherlands
State/province [215] 0 0
Doetinchem
Country [216] 0 0
Netherlands
State/province [216] 0 0
Eindhoven
Country [217] 0 0
Netherlands
State/province [217] 0 0
Enschede
Country [218] 0 0
Netherlands
State/province [218] 0 0
Goes
Country [219] 0 0
Netherlands
State/province [219] 0 0
Harderwijk
Country [220] 0 0
Netherlands
State/province [220] 0 0
Hoofddorp
Country [221] 0 0
Netherlands
State/province [221] 0 0
Leeuwarden
Country [222] 0 0
Netherlands
State/province [222] 0 0
Rotterdam
Country [223] 0 0
Netherlands
State/province [223] 0 0
Sittard-geleen
Country [224] 0 0
Netherlands
State/province [224] 0 0
Sneek
Country [225] 0 0
Netherlands
State/province [225] 0 0
Tiel
Country [226] 0 0
New Zealand
State/province [226] 0 0
Christchurch
Country [227] 0 0
New Zealand
State/province [227] 0 0
Dunedin
Country [228] 0 0
New Zealand
State/province [228] 0 0
Grafton, Auckland
Country [229] 0 0
New Zealand
State/province [229] 0 0
Hamilton
Country [230] 0 0
New Zealand
State/province [230] 0 0
Lower Hutt
Country [231] 0 0
New Zealand
State/province [231] 0 0
Nelson
Country [232] 0 0
New Zealand
State/province [232] 0 0
Otahuhu, Auckland
Country [233] 0 0
New Zealand
State/province [233] 0 0
Palmerston North
Country [234] 0 0
New Zealand
State/province [234] 0 0
Takapuna, Auckland
Country [235] 0 0
New Zealand
State/province [235] 0 0
Tauranga
Country [236] 0 0
New Zealand
State/province [236] 0 0
Timaru
Country [237] 0 0
New Zealand
State/province [237] 0 0
Whangarei
Country [238] 0 0
Norway
State/province [238] 0 0
Bergen
Country [239] 0 0
Norway
State/province [239] 0 0
Moss
Country [240] 0 0
Norway
State/province [240] 0 0
Oslo
Country [241] 0 0
Pakistan
State/province [241] 0 0
Karachi
Country [242] 0 0
Pakistan
State/province [242] 0 0
Korangi / Karachi
Country [243] 0 0
Pakistan
State/province [243] 0 0
Lahore
Country [244] 0 0
Pakistan
State/province [244] 0 0
Multan
Country [245] 0 0
Pakistan
State/province [245] 0 0
Rawalpindi Cantt
Country [246] 0 0
Peru
State/province [246] 0 0
Lima
Country [247] 0 0
Peru
State/province [247] 0 0
Callao
Country [248] 0 0
Philippines
State/province [248] 0 0
Ermita, Manila
Country [249] 0 0
Philippines
State/province [249] 0 0
Manila
Country [250] 0 0
Philippines
State/province [250] 0 0
Quezon City
Country [251] 0 0
Philippines
State/province [251] 0 0
San Juan
Country [252] 0 0
Poland
State/province [252] 0 0
Bydgoszcz
Country [253] 0 0
Poland
State/province [253] 0 0
Gdynia
Country [254] 0 0
Poland
State/province [254] 0 0
Kowanowko
Country [255] 0 0
Poland
State/province [255] 0 0
Krakow
Country [256] 0 0
Poland
State/province [256] 0 0
Mielec
Country [257] 0 0
Poland
State/province [257] 0 0
Ostrow Wielkopolski
Country [258] 0 0
Poland
State/province [258] 0 0
Plonsk
Country [259] 0 0
Poland
State/province [259] 0 0
Radom
Country [260] 0 0
Poland
State/province [260] 0 0
Ruda Slaska
Country [261] 0 0
Poland
State/province [261] 0 0
Siemianowice Slaskie
Country [262] 0 0
Poland
State/province [262] 0 0
Skierniewice
Country [263] 0 0
Poland
State/province [263] 0 0
Torun
Country [264] 0 0
Poland
State/province [264] 0 0
Tychy
Country [265] 0 0
Poland
State/province [265] 0 0
Warszawa
Country [266] 0 0
Poland
State/province [266] 0 0
Wloclawek
Country [267] 0 0
Poland
State/province [267] 0 0
Wroclaw
Country [268] 0 0
Romania
State/province [268] 0 0
Bucharest
Country [269] 0 0
Romania
State/province [269] 0 0
Deva
Country [270] 0 0
Romania
State/province [270] 0 0
Galati
Country [271] 0 0
Romania
State/province [271] 0 0
Targu Mures
Country [272] 0 0
Russian Federation
State/province [272] 0 0
Ekaterinburg
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Russian Federation
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Kemerovo
Country [274] 0 0
Russian Federation
State/province [274] 0 0
Moscow
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Russian Federation
State/province [275] 0 0
Novosibirsk
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Russian Federation
State/province [276] 0 0
Ryazan
Country [277] 0 0
Russian Federation
State/province [277] 0 0
S.-Petresburg
Country [278] 0 0
Russian Federation
State/province [278] 0 0
St Pertersburg
Country [279] 0 0
Russian Federation
State/province [279] 0 0
St'Petersburg
Country [280] 0 0
Russian Federation
State/province [280] 0 0
St-Petersburg
Country [281] 0 0
Russian Federation
State/province [281] 0 0
Yekaterinburg
Country [282] 0 0
Slovakia
State/province [282] 0 0
Bratislava
Country [283] 0 0
Slovakia
State/province [283] 0 0
Kosice
Country [284] 0 0
Slovakia
State/province [284] 0 0
Nitra
Country [285] 0 0
South Africa
State/province [285] 0 0
Gauteng
Country [286] 0 0
South Africa
State/province [286] 0 0
Bellville
Country [287] 0 0
South Africa
State/province [287] 0 0
Bloemfontein
Country [288] 0 0
South Africa
State/province [288] 0 0
Kempton Park
Country [289] 0 0
South Africa
State/province [289] 0 0
Kuils River
Country [290] 0 0
South Africa
State/province [290] 0 0
Moreletapark
Country [291] 0 0
South Africa
State/province [291] 0 0
Olivedale
Country [292] 0 0
South Africa
State/province [292] 0 0
Paarl
Country [293] 0 0
South Africa
State/province [293] 0 0
Parktown West
Country [294] 0 0
South Africa
State/province [294] 0 0
Parow
Country [295] 0 0
South Africa
State/province [295] 0 0
Pinelands
Country [296] 0 0
South Africa
State/province [296] 0 0
Somerset West
Country [297] 0 0
South Africa
State/province [297] 0 0
Soweto
Country [298] 0 0
South Africa
State/province [298] 0 0
Umhlanga
Country [299] 0 0
Spain
State/province [299] 0 0
Alicante
Country [300] 0 0
Spain
State/province [300] 0 0
Granada
Country [301] 0 0
Spain
State/province [301] 0 0
Jerez de la Frontera
Country [302] 0 0
Spain
State/province [302] 0 0
Madrid
Country [303] 0 0
Spain
State/province [303] 0 0
Malaga
Country [304] 0 0
Spain
State/province [304] 0 0
Marid
Country [305] 0 0
Spain
State/province [305] 0 0
Oviedo
Country [306] 0 0
Spain
State/province [306] 0 0
Pozuelo de Alarcón/Madrid
Country [307] 0 0
Spain
State/province [307] 0 0
San Juan (Alicante)
Country [308] 0 0
Spain
State/province [308] 0 0
San Sebastián de los Reyes/Madrid
Country [309] 0 0
Spain
State/province [309] 0 0
San Sebastián
Country [310] 0 0
Spain
State/province [310] 0 0
Santander
Country [311] 0 0
Spain
State/province [311] 0 0
Sevilla
Country [312] 0 0
Spain
State/province [312] 0 0
Sta Coloma de Gramanet (Barcelona)
Country [313] 0 0
Spain
State/province [313] 0 0
Valdemoro/Madrid
Country [314] 0 0
Sweden
State/province [314] 0 0
Eksjö
Country [315] 0 0
Sweden
State/province [315] 0 0
Göteborg
Country [316] 0 0
Sweden
State/province [316] 0 0
Linköping
Country [317] 0 0
Sweden
State/province [317] 0 0
Lund
Country [318] 0 0
Sweden
State/province [318] 0 0
Malmö
Country [319] 0 0
Sweden
State/province [319] 0 0
Stockholm
Country [320] 0 0
Sweden
State/province [320] 0 0
Umeå
Country [321] 0 0
Sweden
State/province [321] 0 0
Uppsala
Country [322] 0 0
Sweden
State/province [322] 0 0
Västervik
Country [323] 0 0
Sweden
State/province [323] 0 0
Västerås
Country [324] 0 0
Sweden
State/province [324] 0 0
Östersund
Country [325] 0 0
Taiwan
State/province [325] 0 0
Changhua
Country [326] 0 0
Taiwan
State/province [326] 0 0
Taichung
Country [327] 0 0
Taiwan
State/province [327] 0 0
Tainan
Country [328] 0 0
Taiwan
State/province [328] 0 0
Taipei City
Country [329] 0 0
Taiwan
State/province [329] 0 0
Taipei
Country [330] 0 0
Thailand
State/province [330] 0 0
Bangkok
Country [331] 0 0
Thailand
State/province [331] 0 0
Chiangmai
Country [332] 0 0
Ukraine
State/province [332] 0 0
Donetsk
Country [333] 0 0
Ukraine
State/province [333] 0 0
Kharkiv
Country [334] 0 0
Ukraine
State/province [334] 0 0
Kyiv
Country [335] 0 0
Ukraine
State/province [335] 0 0
Lviv
Country [336] 0 0
Ukraine
State/province [336] 0 0
Odesa
Country [337] 0 0
Ukraine
State/province [337] 0 0
Vinnytsia
Country [338] 0 0
Ukraine
State/province [338] 0 0
Zaporizhzhia
Country [339] 0 0
United Kingdom
State/province [339] 0 0
Cambridgeshire
Country [340] 0 0
United Kingdom
State/province [340] 0 0
Lanarkshire
Country [341] 0 0
United Kingdom
State/province [341] 0 0
London
Country [342] 0 0
United Kingdom
State/province [342] 0 0
Merseyside
Country [343] 0 0
United Kingdom
State/province [343] 0 0
Middlesex
Country [344] 0 0
United Kingdom
State/province [344] 0 0
Surrey
Country [345] 0 0
United Kingdom
State/province [345] 0 0
Sussex West
Country [346] 0 0
United Kingdom
State/province [346] 0 0
Barnet
Country [347] 0 0
United Kingdom
State/province [347] 0 0
Coatbridge
Country [348] 0 0
United Kingdom
State/province [348] 0 0
Cottingham
Country [349] 0 0
United Kingdom
State/province [349] 0 0
Cumbernauld
Country [350] 0 0
United Kingdom
State/province [350] 0 0
Hamilton
Country [351] 0 0
United Kingdom
State/province [351] 0 0
Hertfordshire
Country [352] 0 0
United Kingdom
State/province [352] 0 0
Liverpool
Country [353] 0 0
United Kingdom
State/province [353] 0 0
Newcastle-upon-Tyne
Country [354] 0 0
United Kingdom
State/province [354] 0 0
Paisley

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00799903