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