A Phase 3, 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough Including Unexplained Chronic Cough (CALM-2)
Status: Recruiting
Location: See all (232) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Capable of giving signed informed consent
• Refractory chronic cough (including unexplained chronic cough) for at least one year
• Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose
Locations
United States
Alabama
GSK Investigational Site
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Foley
Arizona
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Phoenix
California
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Los Angeles
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Los Angeles
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Paramount
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San Diego
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San Diego
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San Jose
Colorado
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Aurora
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Colorado Springs
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Wheat Ridge
Washington, D.c.
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Washington D.c.
Florida
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Daytona Beach
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Fort Lauderdale
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Jacksonville
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Leesburg
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Santa Rosa Beach
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Sarasota
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Sweetwater
Georgia
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Cumming
Iowa
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West Des Moines
Illinois
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Chicago
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River Forest
Massachusetts
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Methuen
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North Dartmouth
Maryland
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Chevy Chase
Minnesota
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Edina
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Woodbury
Missouri
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St Louis
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St Louis
Montana
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Missoula
North Carolina
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COMPLETED
Charlotte
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Gastonia
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Winston-salem
Nebraska
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Omaha
Ohio
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Columbus
Oregon
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Portland
Pennsylvania
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Danville
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Philadelphia
Rhode Island
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Warwick
South Carolina
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Anderson
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Charleston
Tennessee
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COMPLETED
Franklin
Texas
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Cypress
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Dallas
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Frisco
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San Antonio
Virginia
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Norfolk
Other Locations
Australia
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Adelaide
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Chermside
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Coffs Harbour
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Macquarie University
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Nedlands
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New Lambton Heights
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Spearwood
Canada
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Ajax
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Burlington
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Hamilton
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Hamilton
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Montreal
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Québec
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Québec
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Saint-charles-borromée
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Toronto
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Trois-rivières
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Victoriaville
China
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Beijing
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Chengdu
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Chengdu
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Chongqing
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Chongqing
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Dongguan
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Ganzhou
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Guangzhou
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Guangzhou
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Guangzhou
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Guilin
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Hangzhou
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Hefei
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Hefei
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Hefei
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Hohhot
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Huizhou
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Huizhou
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Jiangsu
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Jinan
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Kunming
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Leshan
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Liuzhou
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Meizhou
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Nanchang
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Pingxiang
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Shanghai
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Shanghai
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WITHDRAWN
Shanghai
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Shanghai
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Shenyang
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Shenzhen
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Taizhou
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Ürümqi
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Weifang
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Wuxi
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Xiamen
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Yangzhou
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Yinchuan
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Zhanjiang
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Zhengzhou
Germany
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Berlin
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Berlin
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Darmstadt
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Dresden
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Frankfurt
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Frankfurt
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Frankfurt Am Main
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Fürstenwalde
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Geesthacht
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Halle
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Hamburg
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Hanover
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Hanover
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Heidelberg
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Karlsruhe
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Lübeck
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Marburg
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München
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Neu-isenburg
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Schleswig
India
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Belagavi
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Faridabad
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Gūrgaon
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Nagpur
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Nashik
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Visakhapatnam
Japan
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Aichi
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Aichi
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Akita
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Chiba
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Fukui
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Fukuoka
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Fukuoka
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Fukuoka
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Fukushima
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Gifu
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Gifu
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Gifu
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Hiroshima
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Hiroshima
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Hokkaido
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Hokkaido
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Hyōgo
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Hyōgo
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Hyōgo
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Hyōgo
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Ibaraki
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Kagawa
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Kagoshima
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Kanagawa
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Kanagawa
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Kanagawa
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Kanagawa
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Kyoto
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Kyoto
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Mie
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Miyazaki
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Nagasaki
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Nankoku-shi
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Niigata
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Osaka
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Osaka
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Osaka
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Osaka
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Saitama
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Shizuoka
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Shizuoka
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Shizuoka
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Shizuoka
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Shizuoka
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Tochigi
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Tokyo
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Tokyo
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Tokyo
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Tokyo
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Tokyo
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Tokyo
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Toyama
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Toyama
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Yamaguchi
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Yokohama
New Zealand
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Auckland
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Christchurch
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Christchurch
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Dunedin
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Ebdentown
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Hamilton
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Nelson
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Rotorua
Republic of Korea
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Busan
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Incheon
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Jeonju
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Seongnam
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Seoul
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Seoul
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Seoul
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Seoul
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Seoul
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COMPLETED
Seoul
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COMPLETED
Seoul
GSK Investigational Site
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Seoul
GSK Investigational Site
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Seoul
GSK Investigational Site
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Wŏnju
Slovakia
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Bardejov
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Bardejov
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Humenné
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Kežmarok
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Košice
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Prievidza
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Spišská Nová Ves
Taiwan
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Changhua
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Kaohsiung City
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Kaohsiung City
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COMPLETED
Taoyuan
United Kingdom
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Belfast
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Corby
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Coventry
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Hull
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London
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Northwood
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Orpington
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Preston
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Shipley
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Tyne And Wear
GSK Investigational Site
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Wishaw
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2022-12-05
Estimated Completion Date: 2027-03-23
Participants
Target number of participants: 975
Treatments
Experimental: BLU-5937 25 mg
BLU-5937 oral dose 25 mg twice a day.
Experimental: BLU-5937 50 mg
BLU-5937 oral dose 50 mg twice a day.
Placebo_comparator: Placebo
Matching Placebo for BLU-5937 oral dose twice a day.
Related Therapeutic Areas
Sponsors
Leads: Bellus Health Inc. - a GSK company