Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
225 participants
INTERVENTIONAL
2012-11-30
2015-11-30
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
TRIPLE
Study Groups
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SA09012 Low dose
SA09012 Low dose
Tablet, b.i.d
SA09012 High dose
SA09012 High dose
Tablet, b.i.d
Placebo
Placebo
Tablet, b.i.d
Interventions
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SA09012 Low dose
Tablet, b.i.d
SA09012 High dose
Tablet, b.i.d
Placebo
Tablet, b.i.d
Eligibility Criteria
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Inclusion Criteria
1. Increase in PEF ≥ 20% or ≥ 60L/min from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit
2. Increase in FEV1 ≥ 12% and ≥ 200mL from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit
* FEV1 or PEF between 60% and 85% of the predicted value at screening or within the 3 months of the prestudy visit
* Having signed an informed consent
Exclusion Criteria
* Patient with an AST or ALT \> 2x ULN (upper limit of normal) in the screening visit
* Patient with more than 10 pack year of cigarettes history
20 Years
79 Years
ALL
No
Sponsors
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SamA Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Young Kyoon Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul ST. Mary's Hospital The Catholic University of Korea
Locations
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Chonbuk National University Hospital
Chonbuk, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Ajou University Hospital
Gyeonggi-do, , South Korea
Bucheon St. Mary's Hospital, The Catholic University of Korea
Gyeonggi-do, , South Korea
Hallym University Sacred Heart Hospital
Gyeonggi-do, , South Korea
Soon Chun Hyang University Bucheon Hospital
Gyeonggi-do, , South Korea
Chungbuk National University Hospital
Jungbuk, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
KyungHee University Medical Center
Seoul, , South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, , South Korea
Soonchunhyang University Hospital, Seoul
Seoul, , South Korea
St. Paul's Hospital, The Catholic University of Korea
Seoul, , South Korea
Yonsei University, Gangnam Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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SA09012-P2
Identifier Type: -
Identifier Source: org_study_id
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