nctId: NCT06275724 id: CKJX839A11401 briefTitle: Specified Drug-use Survey of Leqvio for s.c. Injection. overallStatus: RECRUITING date: 2024-03-04 date: 2027-12-31 date: 2027-12-31 date: 2024-02-23 date: 2024-04-26 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice conditions: Familial Hypercholesterolaemia conditions: Hypercholesterolaemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 560 type: ESTIMATED name: inclisiran measure: Number of patients with adverse events measure: Numbers of patients with serious adverse events, adverse events by severity, and adverse drug reactions measure: Number of patients with adverse events leading to discontinuation of treatment with the product measure: Percent change from baseline in LDL-C levels sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis Investigative Site status: RECRUITING city: Handa state: Aichi zip: 475-0817 country: Japan lat: 34.88333 lon: 136.93333 facility: Novartis Investigative Site status: RECRUITING city: Ichinomiya state: Aichi zip: 491-8551 country: Japan lat: 35.3 lon: 136.8 facility: Novartis Investigative Site status: RECRUITING city: Komaki state: Aichi zip: 485-8520 country: Japan lat: 35.28333 lon: 136.91667 facility: Novartis Investigative Site status: RECRUITING city: Nagoya state: Aichi zip: 454-0933 country: Japan lat: 35.18147 lon: 136.90641 facility: Novartis Investigative Site status: RECRUITING city: Nagoya state: Aichi zip: 461-0045 country: Japan lat: 35.18147 lon: 136.90641 facility: Novartis Investigative Site status: RECRUITING city: Toyoake city state: Aichi zip: 470 1192 country: Japan lat: 35.038 lon: 136.99931 facility: Novartis Investigative Site status: RECRUITING city: Matsuyama state: Ehime zip: 791-8016 country: Japan lat: 33.83916 lon: 132.76574 facility: Novartis Investigative Site status: RECRUITING city: Fukuoka-city state: Fukuoka zip: 811-0213 country: Japan lat: 33.6 lon: 130.41667 facility: Novartis Investigative Site status: RECRUITING city: Kitakyushu state: Fukuoka zip: 800-0031 country: Japan lat: 33.85181 lon: 130.85034 facility: Novartis Investigative Site status: RECRUITING city: Shirakawa state: Fukushima zip: 961-0005 country: Japan facility: Novartis Investigative Site status: RECRUITING city: Kure-city state: Hiroshima zip: 737-0023 country: Japan lat: 34.23222 lon: 132.56658 facility: Novartis Investigative Site status: RECRUITING city: Asahikawa state: Hokkaido zip: 078-8214 country: Japan lat: 43.77063 lon: 142.36489 facility: Novartis Investigative Site status: RECRUITING city: Sapporo state: Hokkaido zip: 004-0052 country: Japan lat: 43.06667 lon: 141.35 facility: Novartis Investigative Site status: RECRUITING city: Sapporo state: Hokkaido zip: 065-0027 country: Japan lat: 43.06667 lon: 141.35 facility: Novartis Investigative Site status: RECRUITING city: Amagasaki state: Hyogo zip: 660-8511 country: Japan lat: 34.71667 lon: 135.41667 facility: Novartis Investigative Site status: RECRUITING city: Himeji state: Hyogo zip: 670-8560 country: Japan lat: 34.81667 lon: 134.7 facility: Novartis Investigative Site status: RECRUITING city: Kobe state: Hyogo zip: 654-0026 country: Japan lat: 34.6913 lon: 135.183 facility: Novartis Investigative Site status: RECRUITING city: Takarazuka-city state: Hyogo zip: 665-0873 country: Japan lat: 34.79936 lon: 135.35697 facility: Novartis Investigative Site status: RECRUITING city: Moriya-city state: Ibaraki zip: 302-0102 country: Japan lat: 35.93333 lon: 140.0 facility: Novartis Investigative Site status: RECRUITING city: Kanazawa-city state: Ishikawa zip: 920-8641 country: Japan lat: 36.6 lon: 136.61667 facility: Novartis Investigative Site status: RECRUITING city: Fujisawa state: Kanagawa zip: 252-0802 country: Japan lat: 35.34926 lon: 139.47666 facility: Novartis Investigative Site status: RECRUITING city: Yokohama state: Kanagawa zip: 235-0016 country: Japan lat: 35.43333 lon: 139.65 facility: Novartis Investigative Site status: RECRUITING city: Yokosuka state: Kanagawa zip: 238-8567 country: Japan lat: 35.28361 lon: 139.66722 facility: Novartis Investigative Site status: RECRUITING city: Yokosuka state: Kanagawa zip: 240-0101 country: Japan lat: 35.28361 lon: 139.66722 facility: Novartis Investigative Site status: RECRUITING city: Kumamoto-city state: Kumamoto zip: 861-4193 country: Japan lat: 32.80589 lon: 130.69182 facility: Novartis Investigative Site status: RECRUITING city: Yatsushiro-city state: Kumamoto zip: 866-8533 country: Japan lat: 32.55723 lon: 130.65285 facility: Novartis Investigative Site status: RECRUITING city: Kyotanabe state: Kyoto zip: 610-0334 country: Japan lat: 34.8045 lon: 135.76681 facility: Novartis Investigative Site status: RECRUITING city: Kyoto-city state: Kyoto zip: 602-8566 country: Japan lat: 35.02107 lon: 135.75385 facility: Novartis Investigative Site status: RECRUITING city: Kyoto-city state: Kyoto zip: 607-8062 country: Japan lat: 35.02107 lon: 135.75385 facility: Novartis Investigative Site status: RECRUITING city: Omura state: Nagasaki zip: 856-8562 country: Japan lat: 32.92139 lon: 129.95389 facility: Novartis Investigative Site status: RECRUITING city: Ikoma state: Nara zip: 636-0802 country: Japan lat: 34.68333 lon: 135.7 facility: Novartis Investigative Site status: RECRUITING city: Kashihara state: Nara zip: 634-0045 country: Japan lat: 34.50896 lon: 135.7929 facility: Novartis Investigative Site status: RECRUITING city: Nagaoka-city state: Niigata zip: 940-8621 country: Japan lat: 37.45 lon: 138.85 facility: Novartis Investigative Site status: RECRUITING city: Oita-city state: Oita zip: 870-0263 country: Japan lat: 33.23333 lon: 131.6 facility: Novartis Investigative Site status: RECRUITING city: Kurashiki state: Okayama zip: 713-8121 country: Japan lat: 34.58333 lon: 133.76667 facility: Novartis Investigative Site status: RECRUITING city: Okayama-city state: Okayama zip: 700-8558 country: Japan lat: 34.65 lon: 133.93333 facility: Novartis Investigative Site status: RECRUITING city: Urasoe state: Okinawa zip: 901-2102 country: Japan lat: 26.25902 lon: 127.73012 facility: Novartis Investigative Site status: RECRUITING city: Uruma state: Okinawa zip: 904-2293 country: Japan lat: 26.37609 lon: 127.85908 facility: Novartis Investigative Site status: RECRUITING city: Izumisano-city state: Osaka zip: 598-8577 country: Japan lat: 34.41663 lon: 135.31667 facility: Novartis Investigative Site status: RECRUITING city: Moriguchi state: Osaka zip: 570-8507 country: Japan lat: 34.73333 lon: 135.56667 facility: Novartis Investigative Site status: RECRUITING city: Osaka-city state: Osaka zip: 540-0006 country: Japan lat: 34.69374 lon: 135.50218 facility: Novartis Investigative Site status: RECRUITING city: Osaka-city state: Osaka zip: 543-0035 country: Japan lat: 34.69374 lon: 135.50218 facility: Novartis Investigative Site status: RECRUITING city: Osaka-city state: Osaka zip: 543-8555 country: Japan lat: 34.69374 lon: 135.50218 facility: Novartis Investigative Site status: RECRUITING city: Takatsuki-city state: Osaka zip: 569-0852 country: Japan lat: 34.84833 lon: 135.61678 facility: Novartis Investigative Site status: RECRUITING city: Takatsuki-city state: Osaka zip: 569-8686 country: Japan lat: 34.84833 lon: 135.61678 facility: Novartis Investigative Site status: RECRUITING city: Takatsuki state: Osaka zip: 569-1121 country: Japan lat: 34.84833 lon: 135.61678 facility: Novartis Investigative Site status: RECRUITING city: Toyonaka state: Osaka zip: 560-0083 country: Japan lat: 34.78244 lon: 135.46932 facility: Novartis Investigative Site status: RECRUITING city: Asaka state: Saitama zip: 351-0021 country: Japan lat: 35.80472 lon: 139.60194 facility: Novartis Investigative Site status: RECRUITING city: Gyoda state: Saitama zip: 361-0056 country: Japan lat: 36.14074 lon: 139.46011 facility: Novartis Investigative Site status: RECRUITING city: Tokorozawa state: Saitama zip: 359-1142 country: Japan lat: 35.79916 lon: 139.46903 facility: Novartis Investigative Site status: RECRUITING city: Nagahama state: Shiga zip: 526-8580 country: Japan lat: 35.38333 lon: 136.26667 facility: Novartis Investigative Site status: RECRUITING city: Hachioji-city state: Tokyo zip: 192-0918 country: Japan lat: 35.65583 lon: 139.32389 facility: Novartis Investigative Site status: RECRUITING city: Machida state: Tokyo zip: 194-0021 country: Japan lat: 35.54028 lon: 139.45083 facility: Novartis Investigative Site status: RECRUITING city: Nerima-ku state: Tokyo zip: 176-8530 country: Japan facility: Novartis Investigative Site status: RECRUITING city: Shinjuku state: Tokyo zip: 160-8488 country: Japan lat: 35.2946 lon: 139.57059 facility: Novartis Investigative Site status: RECRUITING city: Toshima-ku state: Tokyo zip: 171-0014 country: Japan facility: Novartis Investigative Site status: RECRUITING city: Takaoka state: Toyama zip: 939-1104 country: Japan lat: 36.75 lon: 137.01667 facility: Novartis Investigative Site status: RECRUITING city: Hashimoto state: Wakayama zip: 648-0005 country: Japan lat: 34.31667 lon: 135.61667 facility: Novartis Investigative Site status: RECRUITING city: Sakata-city state: Yamagata zip: 998-8501 country: Japan lat: 38.91667 lon: 139.855 facility: Novartis Investigative Site status: RECRUITING city: Fukuoka zip: 815-0082 country: Japan lat: 33.6 lon: 130.41667 facility: Novartis Investigative Site status: RECRUITING city: Gifu zip: 500-8384 country: Japan lat: 35.42291 lon: 136.76039 facility: Novartis Investigative Site status: RECRUITING city: Kagoshima zip: 892-0853 country: Japan lat: 31.56667 lon: 130.55 facility: Novartis Investigative Site status: RECRUITING city: Nagasaki zip: 852-8055 country: Japan lat: 32.75 lon: 129.88333 facility: Novartis Investigative Site status: RECRUITING city: Oita zip: 870-1133 country: Japan lat: 33.23333 lon: 131.6 facility: Novartis Investigative Site status: RECRUITING city: Oita zip: 879-7761 country: Japan lat: 33.23333 lon: 131.6 facility: Novartis Investigative Site status: RECRUITING city: Osaka zip: 545-8586 country: Japan lat: 34.69374 lon: 135.50218 hasResults: False