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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
Uncontrolled, central registration system, multicenter, special drug use-results surveillance.
This is a prospective, open-label, multicenter, single-arm observational study (non-interventional study: NIS) conducted only in Japan.
The survey will include patients with familial hypercholesterolaemia or hypercholesterolaemia who have received treatment with Leqvio. Patients who discontinued treatment with Leqvio before completing the 24-month observation period will be followed for safety until the date of the last dose of Leqvio plus 180 days or until 24 months after the first dose of Leqvio, whichever comes earlier.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| inclisiran | Patients prescribed with inclisiran |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inclisiran | Other | Prospective observational study. There is no treatment allocation. Patients prescribed with inclisiran are eligible to enroll into this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | To evaluate the long-term safety profile of Leqvio | Up to 24 months |
| Numbers of patients with serious adverse events, adverse events by severity, and adverse drug reactions | To evaluate the long-term safety profile of Leqvio | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events leading to discontinuation of treatment with the product | To evaluate the tolerability of Leqvio | Up to 24 months |
| Percent change from baseline in LDL-C levels |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with inclisiran
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Handa | Aichi-ken | 475-0817 | Japan | ||
| Novartis Investigative Site |
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To evaluate the efficacy of Leqvio based on LDL-C levels
| Month 24 |
| Ichinomiya |
| Aichi-ken |
| 491-8551 |
| Japan |
| Novartis Investigative Site | Ichinomiya | Aichi-ken | 494-0001 | Japan |
| Novartis Investigative Site | Komaki | Aichi-ken | 485-8520 | Japan |
| Novartis Investigative Site | Nagoya | Aichi-ken | 4540933 | Japan |
| Novartis Investigative Site | Nagoya | Aichi-ken | 461-0045 | Japan |
| Novartis Investigative Site | Toyoake | Aichi-ken | 4701192 | Japan |
| Novartis Investigative Site | Tsushima | Aichi-ken | 496-0038 | Japan |
| Novartis Investigative Site | Asahi | Chiba | 289-2511 | Japan |
| Novartis Investigative Site | Inzai | Chiba | 270-1694 | Japan |
| Novartis Investigative Site | Urayasu | Chiba | 279-0021 | Japan |
| Novartis Investigative Site | Matsuyama | Ehime | 791-8016 | Japan |
| Novartis Investigative Site | Fukui-shi | Fukui | 910-8526 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 8140180 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 815-0082 | Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 800-0031 | Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 8078556 | Japan |
| Novartis Investigative Site | Fukushima | Fukushima | 960-8611 | Japan |
| Novartis Investigative Site | Kōriyama | Fukushima | 963-8501 | Japan |
| Novartis Investigative Site | Shirakawa | Fukushima | 961-0005 | Japan |
| Novartis Investigative Site | Gifu | Gifu | 500-8384 | Japan |
| Novartis Investigative Site | Hiroshima | Hiroshima | 7320053 | Japan |
| Novartis Investigative Site | Kure | Hiroshima | 737-0023 | Japan |
| Novartis Investigative Site | Asahikawa | Hokkaido | 0788211 | Japan |
| Novartis Investigative Site | Asahikawa | Hokkaido | 0788214 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 0040052 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 0620003 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 065-0027 | Japan |
| Novartis Investigative Site | Amagasaki | Hyōgo | 660-8511 | Japan |
| Novartis Investigative Site | Himeji | Hyōgo | 6708560 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 654-0026 | Japan |
| Novartis Investigative Site | Ono | Hyōgo | 675-1327 | Japan |
| Novartis Investigative Site | Takarazuka | Hyōgo | 665-0873 | Japan |
| Novartis Investigative Site | Kamisu | Ibaraki | 314-0146 | Japan |
| Novartis Investigative Site | Koga | Ibaraki | 306-0232 | Japan |
| Novartis Investigative Site | Mito | Ibaraki | 310-0015 | Japan |
| Novartis Investigative Site | Moriya | Ibaraki | 302-0102 | Japan |
| Novartis Investigative Site | Tsukuba | Ibaraki | 3058576 | Japan |
| Novartis Investigative Site | Kagoshima | Kagoshima-ken | 890-8760 | Japan |
| Novartis Investigative Site | Fujisawa | Kanagawa | 252-0802 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 224-8503 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 235-0016 | Japan |
| Novartis Investigative Site | Yokosuka | Kanagawa | 239-8567 | Japan |
| Novartis Investigative Site | Yokosuka | Kanagawa | 240-0101 | Japan |
| Novartis Investigative Site | Yatsushiro | Kumamoto | 866-8533 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 602-8566 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 612-8555 | Japan |
| Novartis Investigative Site | Kyōtanabe | Kyoto | 610-0334 | Japan |
| Novartis Investigative Site | Tsu | Mie-ken | 514-8507 | Japan |
| Novartis Investigative Site | Nagasaki | Nagasaki | 8508555 | Japan |
| Novartis Investigative Site | Nagasaki | Nagasaki | 852-8055 | Japan |
| Novartis Investigative Site | Ōmura | Nagasaki | 856-8562 | Japan |
| Novartis Investigative Site | Ikoma | Nara | 636-0802 | Japan |
| Novartis Investigative Site | Kashihara | Nara | 634-0045 | Japan |
| Novartis Investigative Site | Tenri | Nara | 632-8552 | Japan |
| Novartis Investigative Site | Nagaoka | Niigata | 940-8621 | Japan |
| Novartis Investigative Site | Ōita | Oita Prefecture | 870-0263 | Japan |
| Novartis Investigative Site | Ōita | Oita Prefecture | 870-1133 | Japan |
| Novartis Investigative Site | Ōita | Oita Prefecture | 879-7761 | Japan |
| Novartis Investigative Site | Kurashiki | Okayama-ken | 7108602 | Japan |
| Novartis Investigative Site | Urasoe | Okinawa | 901-2102 | Japan |
| Novartis Investigative Site | Uruma | Okinawa | 904-2293 | Japan |
| Novartis Investigative Site | Izumisano | Osaka | 5988577 | Japan |
| Novartis Investigative Site | Moriguchi | Osaka | 570-8507 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 5400006 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 543-8922 | Japan |
| Novartis Investigative Site | Takatsuki | Osaka | 569-0852 | Japan |
| Novartis Investigative Site | Takatsuki | Osaka | 569-1121 | Japan |
| Novartis Investigative Site | Takatsuki | Osaka | 5698686 | Japan |
| Novartis Investigative Site | Toyonaka | Osaka | 560-0083 | Japan |
| Novartis Investigative Site | Asaka | Saitama | 3510021 | Japan |
| Novartis Investigative Site | Gyōda | Saitama | 361-0056 | Japan |
| Novartis Investigative Site | Iruma-gun | Saitama | 3500495 | Japan |
| Novartis Investigative Site | Kitamoto | Saitama | 364-8501 | Japan |
| Novartis Investigative Site | Sōka | Saitama | 340-0043 | Japan |
| Novartis Investigative Site | Tokorozawa | Saitama | 359-1142 | Japan |
| Novartis Investigative Site | Nagahama | Shiga | 526-8580 | Japan |
| Novartis Investigative Site | Izunokuni | Shizuoka | 410-2295 | Japan |
| Novartis Investigative Site | Mooka | Tochigi | 321-4306 | Japan |
| Novartis Investigative Site | Hachiōji | Tokyo | 192-0918 | Japan |
| Novartis Investigative Site | Machida | Tokyo | 194-0021 | Japan |
| Novartis Investigative Site | Meguro City | Tokyo | 153-8515 | Japan |
| Novartis Investigative Site | Minato | Tokyo | 106-0031 | Japan |
| Novartis Investigative Site | Nerima-ku | Tokyo | 176-8530 | Japan |
| Novartis Investigative Site | Shinjuku | Tokyo | 160-8488 | Japan |
| Novartis Investigative Site | Shinjuku Ku | Tokyo | 1628666 | Japan |
| Novartis Investigative Site | Sumida City | Tokyo | 130-8575 | Japan |
| Novartis Investigative Site | Toshima-ku | Tokyo | 171-0014 | Japan |
| Novartis Investigative Site | Takaoka | Toyama | 939-1104 | Japan |
| Novartis Investigative Site | Hashimoto | Wakayama | 648-0005 | Japan |
| Novartis Investigative Site | Sakata | Yamagata | 998-8501 | Japan |
| Novartis Investigative Site | Yamagata | Yamagata | 990-9585 | Japan |
| Novartis Investigative Site | Akita | 0108577 | Japan |
| Novartis Investigative Site | Chiba | 261-0024 | Japan |
| Novartis Investigative Site | Fukuoka | 811-0213 | Japan |
| Novartis Investigative Site | Fukushima | 9601295 | Japan |
| Novartis Investigative Site | Himeji | 671-1227 | Japan |
| Novartis Investigative Site | Ishikawa | 9208641 | Japan |
| Novartis Investigative Site | Kagoshima | 892-0853 | Japan |
| Novartis Investigative Site | Kumamoto | 861-4193 | Japan |
| Novartis Investigative Site | Kyoto | 6078062 | Japan |
| Novartis Investigative Site | Nara | 630-8581 | Japan |
| Novartis Investigative Site | Okayama | 7008558 | Japan |
| Novartis Investigative Site | Osaka | 543-8555 | Japan |
| Novartis Investigative Site | Osaka | 5458586 | Japan |
| Novartis Investigative Site | Osaka | 558-8558 | Japan |
| Novartis Investigative Site | Shizuoka | 422-8527 | Japan |
| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| D006937 | Hypercholesterolemia |
| D000090542 | Homozygous Familial Hypercholesterolemia |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C585830 | ALN-PCS |
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