A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases
NCT ID: NCT00554229
Last Updated: 2016-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
896 participants
INTERVENTIONAL
2007-11-30
2011-08-31
Brief Summary
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* This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo.
* ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases.
* All patients participating in this clinical trial will receive existing standard prostate cancer treatments in addition to trial therapy.
* Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.
* No patients will be deprived of standard prostate cancer therapy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ZD4054
ZD4054 10 mg oral tablet once daily
ZD4054
ZD4054 10 mg oral tablet once daily
Placebo
Matching Placebo, oral tablets once daily
Placebo
Matching placebo oral tablet once daily
Interventions
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ZD4054
ZD4054 10 mg oral tablet once daily
Placebo
Matching placebo oral tablet once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastases)
2. Increasing Prostate Specific Antigen (PSA) over a one month period
3. No pain, or mild pain from prostate cancer
4. Currently receiving treatment with surgical or medical castration
Exclusion Criteria
1. Currently using opiates based pain killers)
2. Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)
3. Suffering from heart failure or had a myocardial infarction within last 6 months
4. A history of epilepsy or seizures
18 Years
MALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Gleave, MD, FRCSC, FACS
Role: PRINCIPAL_INVESTIGATOR
The Prostate Centre at Vancouver General Hospital
Joel B Nelson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Tucson, Arizona, United States
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Greenbrae, California, United States
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Los Angeles, California, United States
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Palm Springs, California, United States
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San Mateo, California, United States
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Norwich, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Gainsville, Florida, United States
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Port St.Lucie, Florida, United States
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Des Moines, Iowa, United States
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Canton, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Nashville, Tennessee, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Norfolk, Virginia, United States
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Seattle, Washington, United States
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Wheeling, West Virginia, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, Buenos Aires, Argentina
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Santa Fe, Santa Fe Province, Argentina
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Hornsby, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Redcliffe, Queensland, Australia
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Ashford, South Australia, Australia
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Subiaco, Western Australia, Australia
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Graz, Graz, Austria
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Wels, Wels, Austria
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Brussels, Brussels Capital, Belgium
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Ghent, Gent, Belgium
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Kortrijk, Kortrijk, Belgium
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Leuven, Leuven, Belgium
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Fortaleza, Ceará, Brazil
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Goiânia, Goiás, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Ribeirão Preto, São Paulo, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Kentville, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Burlington, Ontario, Canada
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Hamilton, Ontario, Canada
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Kitchener, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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North York, Ontario, Canada
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Oakville, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Granby, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Point-Claire, Quebec, Canada
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Québec, Quebec, Canada
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Haidian District, Beijing Municipality, China
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XI Cheng District, Beijing Municipality, China
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Xicheng District, Beijing Municipality, China
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Wuhan, Hubei, China
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Nanjing, Jiangsu, China
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Pudong New Area, Shanghai Municipality, China
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Shanghai, Shanghai Municipality, China
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Xuhui District, Shanghai Municipality, China
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Xi’an, Shanxi, China
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Brno, Brno, Czechia
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Olomouc, Olomouc, Czechia
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Prague, Prague, Czechia
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Ústí nad Labem, Usti nad Labem, Czechia
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Aalborg, Aalborg, Denmark
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Aarhus, Aarhus, Denmark
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Herlev, Herlev, Denmark
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Copenhagen, Kobenhavn, Denmark
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Joensuu, Joensuu, Finland
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Kajaanintie, Kajaanintie, Finland
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Tampere, Pirkanmaa, Finland
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Montpellier, Montpellier, France
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Paris, Paris, France
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Poitiers, Poitiers Cedex, France
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Suresnes, Suresnes, France
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Toulouse, Toulouse, France
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Villejuif, Villejuif, France
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Augsburg, Augsburg, Germany
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Bad Gegeberg, Bad Gegeberg, Germany
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Emmendingen, Emmendingen, Germany
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Leipzig, Leipzig, Germany
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Lübeck, Luebeck, Germany
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Mannheim, Mannheim, Germany
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München, Muenchen, Germany
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Planegg, Muenchen, Germany
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Reutlingen, Reutlingen, Germany
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Berlin, State of Berlin, Germany
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Kirchheim, Teck, Germany
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Hong Kong, Hong Kong, Hong Kong
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Tuenmen, Hong Kong, Hong Kong
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Shatin, Shatin, Hong Kong
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Budapest, Budapest, Hungary
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Debrecen, Debrecen, Hungary
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Miskolc, Miskolc, Hungary
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Nyíregyháza, Nyiregyhaza, Hungary
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Szeged, Szeged, Hungary
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Gujarat, Gujarat, India
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Trivandrum, Kerala, India
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Bhopal, Madhya Pradesh, India
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Mumbai, Maharashtra, India
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Rohini, National Capital Territory of Delhi, India
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New Delhi, New Delhi, India
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Chandigarh, Punjab, India
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Ludhiana, Punjab, India
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Bikaner, Rajasthan, India
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Jaipur, Rajasthan, India
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Kolkota, West Bengal, India
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Milan, Milan, Italy
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Rome, Rome, Italy
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Asahi, Chiba, Japan
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Chiba, Chiba, Japan
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Narashino, Chiba, Japan
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Matsuyama, Ehime, Japan
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Fukuoka, Fukuoka, Japan
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Maebashi, Gunma, Japan
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Ōtake, Hiroshima, Japan
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Sapporo, Hokkaido, Japan
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Kobe, Hyōgo, Japan
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Tsukuba, Ibaraki, Japan
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Kita-gun, Kagawa-ken, Japan
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Sagamihara, Kanagawa, Japan
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Kyoto, Kyoto, Japan
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Sendai, Miyagi, Japan
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Nagasaki, Nagasaki, Japan
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Ōita, Oita Prefecture, Japan
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Osaka, Osaka, Japan
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Ōsaka-sayama, Osaka, Japan
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Suita, Osaka, Japan
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Wako, Saitama, Japan
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Hamamatsu, Shizuoka, Japan
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Sunto-gun, Shizuoka, Japan
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Bunkyo-ku, Tokyo, Japan
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Fuchu_city, Tokyo, Japan
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Itabashi-Ku, Tokyo, Japan
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Meguro-ku, Tokyo, Japan
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Mitaka, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Mexico City, Mexico City, Mexico
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Distrito Federal Ciudad, Mexico, Mexico
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Metepec, State of Mexico, Mexico
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Amsterdam, Amsterdam, Netherlands
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Eindhoven, Eindhoven, Netherlands
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Nijmegen, Nijmegen, Netherlands
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Groningen, Provincie Groningen, Netherlands
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Bialystok, Bialystok, Poland
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Kościerzyna, Koscierzyna, Poland
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Krakow, Krakow, Poland
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Rzeszów, Rzeszow, Poland
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Warsaw, Warszawa, Poland
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Wroclaw, Wroclaw, Poland
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Coimbra, Coimbra District, Portugal
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Lisbon, Lisbon District, Portugal
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Porto, Porto District, Portugal
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Barnaul, Barnaul, Russia
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Stary Oskol, Belgorod Oblast, Russia
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Izhevsk, Izhevsk, Russia
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Kursk, Kursk Oblast, Russia
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Moscow, Moscow, Russia
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Saint Petersgurg, Saint Petersgurg, Russia
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Sochi, Sochi, Russia
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Voronezh, Voronezh Oblast, Russia
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Belgrade, Belgrade, Serbia
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Niš, Nis, Serbia
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Novi Sad, Novi Sad, Serbia
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Singapore, Singapore, Singapore
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Bloemfontein, Bloemfontein, South Africa
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Tygerberg, Cape Town, South Africa
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Pietermaritzburg, Pietermaritzburg, South Africa
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Port Elizabeth, Port Elizabeth, South Africa
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Seo-gu, Busan, South Korea
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Seongnam-si, Gyeonggi-do, South Korea
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Heungduk-gu Cheongju, North Chungcheong, South Korea
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Gangnam-gu, Seoul, South Korea
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Songpa-gu, Seoul, South Korea
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Gothenburg, Goteborg, Sweden
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Gothenburg, Gothenburg, Sweden
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Stockholm, Stockholm County, Sweden
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Basel, Basel, Switzerland
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Bern, Canton of Bern, Switzerland
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Locarno, Locarno, Switzerland
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Sursee, Sursee, Switzerland
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Kaohsiung City, Kaohsiung, Taiwan
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Taipei, Taipei, Taiwan
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Taoyuan District, Taiwan, Taiwan
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Reading, Berkshire, United Kingdom
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Cambridge, Cambridgeshire, United Kingdom
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Maidstone, Kent, United Kingdom
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London, London, United Kingdom
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Huddersfield, Yorkshire, United Kingdom
Countries
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Other Identifiers
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2007-003227-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D4320C00014
Identifier Type: -
Identifier Source: org_study_id
NCT00707395
Identifier Type: -
Identifier Source: nct_alias
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