A 24-week, multicenter, randomized, double-blind, parallel-arm, placebo-controlled extension study to assess the safety of CSJ117, when added to existing standard of care asthma therapy in patients >=18 years of age who completed study CCSJ117A12201C
喘息患者を対象としたCSJ117の安全性を評価する試験
Study of safety of CSJ117 in participants with moderate to severe uncontrolled asthma
(2)治験責任医師等に関する事項
山田 博之
Yamada Hiroyuki
/
ノバルティス ファーマ株式会社
Novartis Pharma. K.K.
105-6333
/
東京都港区虎ノ門1丁目23番1号 虎ノ門ヒルズ森タワー
Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
0120-003-293
rinshoshiken.toroku@novartis.com
山田 博之
Yamada Hiroyuki
ノバルティス ファーマ株式会社
Novartis Pharma. K.K.
105-6333
東京都港区虎ノ門1丁目23番1号 虎ノ門ヒルズ森タワー
Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
1. Participants completing the Treatment period of prior study and continuing with this study must have completed the Treatment period of prior study.
2. Participants completing the Treatment period and Follow-up period of prior study and continuing with this study must have completed the Treatment period of prior study and Follow-up period of the core study.
1. Participants prematurely discontinued irrespective of the reason from the prior study.
2. Participants who were enrolled into prior study and developed a significant and/or permanent health condition during the prior study that would have excluded them from participation in that study.
年齢下限 / Age Minimum
18歳 以上
18age old over
年齢上限 / Age Maximum
75歳 以下
75age old under
性別 / Gender
男性・女性
Both
中止基準
対象疾患名 / Health Condition(s) or Problem(s) Studied
喘息
Asthma
対象疾患コード / Code
対象疾患キーワード / Keyword
介入の有無
あり
介入の内容 / Intervention(s)
CSJ117もしくはプラセボの1日1回の投与
CSJ117 or placebo administered once daily
介入コード / Code
介入キーワード /Keyword
主たる評価項目 / Primary Outcome(s)
治験治療下で発現したAE,治験薬の投与中止に至ったAE及びSAE
Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs)