Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility
NCT ID: NCT01902290
Last Updated: 2022-09-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
421 participants
INTERVENTIONAL
2013-05-22
2015-05-15
Brief Summary
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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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Placebo
Participants received placebo administered by subcutaneous injection on day 1, week 1, week 2 and every 2 weeks thereafter for 24 weeks.
Placebo
Placebo administered subcutaneously
Brodalumab 210 mg
Participants received 210 mg brodalumab administered by subcutaneous injection on day 1, week 1, week 2, and every 2 weeks thereafter for 24 weeks.
Brodalumab
Brodalumab administered subcutaneously
Interventions
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Placebo
Placebo administered subcutaneously
Brodalumab
Brodalumab administered subcutaneously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Percent of predicted FEV1 ≥ 40% and ≤ 80% at screening
* Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000/μg/day fluticasone powder or equivalent
* Ongoing asthma symptoms with asthma control questionnaire (ACQ) composite score at screening and baseline ≥ 1.5 points
Exclusion Criteria
* History of allergic bronchopulmonary aspergillosis
* Respiratory infection within 4 weeks of screening or 1 week of baseline visit
* Subject has known history of Crohn's disease
* Subject has any other significant concurrent medical condition of laboratory abnormalities, as defined in the study protocol
* Subject has previously used any anti-interleukin-17 (IL17) biologic therapy
* Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
* Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile
* Subject has severe depression measured by Personal Health Questionnaire Depression Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating Scale (e-CSSRS)
* Subject has a history or evidence of psychiatric disorder or substance abuse considered by the Investigator to pose a risk to subject safety
18 Years
75 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
AstraZeneca
INDUSTRY
Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Birmingham, Alabama, United States
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Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Bakersfield, California, United States
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Encinitas, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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North Hollywood, California, United States
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Orange, California, United States
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Palmdale, California, United States
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Rolling Hills Estates, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Santa Monica, California, United States
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Stockton, California, United States
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Colorado Springs, Colorado, United States
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Waterbury, Connecticut, United States
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Aventura, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Lynn Haven, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Port Orange, Florida, United States
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Tallahassee, Florida, United States
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Decatur, Georgia, United States
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Lawrenceville, Georgia, United States
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Eagle, Idaho, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Normal, Illinois, United States
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Peoria, Illinois, United States
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Iowa City, Iowa, United States
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Paducah, Kentucky, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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North Dartmouth, Massachusetts, United States
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Plymouth, Minnesota, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Bellevue, Nebraska, United States
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Ocean City, New Jersey, United States
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Albuquerque, New Mexico, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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High Point, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Dublin, Ohio, United States
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Middleburg Heights, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Lake Oswego, Oregon, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Upland, Pennsylvania, United States
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Rock Hill, South Carolina, United States
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Spartanburg, South Carolina, United States
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Bristol, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Arlington, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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McKinney, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Clinton, Utah, United States
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Bellingham, Washington, United States
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Milwaukee, Wisconsin, United States
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New Lambton, New South Wales, Australia
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Nedlands, Western Australia, Australia
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Sherwood Park, Alberta, Canada
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Kelowna, British Columbia, Canada
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Surrey, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Brampton, Ontario, Canada
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Hamilton, Ontario, Canada
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Newmarket, Ontario, Canada
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Sarnia, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Trois-Rivières, Quebec, Canada
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Le Kremlin-Bicêtre, , France
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Marseille, , France
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Montpellier, , France
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Pessac, , France
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Saint-Herblain, , France
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Strasbourg, , France
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Tours, , France
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Berlin, , Germany
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Berlin, , Germany
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Bonn, , Germany
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Cottbus, , Germany
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Frankfurt am Main, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Mainz, , Germany
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Radebeul, , Germany
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Rüdersdorf, , Germany
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Alexandroupoli, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Chaidari, Athens, , Greece
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Heraklion - Crete, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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New Territories, , Hong Kong
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Cork, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Catania, , Italy
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Ferrara, , Italy
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Genova, , Italy
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Modena, , Italy
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Padua, , Italy
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Pavia, , Italy
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Pisa, , Italy
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Tradate (VA), , Italy
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Christchurch, , New Zealand
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Dunedin, , New Zealand
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Remuera, , New Zealand
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Bialystok, , Poland
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Bialystok, , Poland
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Gdynia, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Skierniewice, , Poland
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Tarnów, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Zgierz, , Poland
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San Juan, , Puerto Rico
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Bucheon-si, Gyeonggi-do, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Wonju-si, Gangwon-do, , South Korea
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
Countries
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References
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Globe G, Wiklund I, Mattera M, Zhang H, Revicki DA. Evaluating minimal important differences and responder definitions for the asthma symptom diary in patients with moderate to severe asthma. J Patient Rep Outcomes. 2019 Apr 3;3(1):22. doi: 10.1186/s41687-019-0109-2.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2012-003351-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20120141
Identifier Type: -
Identifier Source: org_study_id
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