Hypercholesterolemia Clinical Trial
Official title:
Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab (AMG 145) in Japan
| NCT number | NCT02808403 |
| Other study ID # | 20140409 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 24, 2016 |
| Est. completion date | March 30, 2023 |
| Verified date | April 2023 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this post-marketing survey is to obtain real-world information on the safety and effectiveness of evolocumab in Japan.
| Status | Completed |
| Enrollment | 6000 |
| Est. completion date | March 30, 2023 |
| Est. primary completion date | October 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Patients for whom evolocumab is prescribed at participating medical institutions in accordance with the approved Japan prescribing information (i.e., those with Familial Hypercholesterolemia (Heterozygous or Homozygous and Hypercholesterolemia who have high risk factors for cardiovascular event and do not respond sufficiently to HMGCoA reductase inhibitor (statin) for hypercholesterolemia). Exclusion Criteria: - No exclusion criteria are applied. |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Research Site | Ageo city | Saitama Prefecture |
| Japan | Research Site | Akita city | Akita Prefecture |
| Japan | Research Site | Asahi city | Chiba Prefecture |
| Japan | Research Site | Chiba City | Chiba Prefecture |
| Japan | Research Site | Chosei Gun | Chiba Prefecture |
| Japan | Research Site | Chuoku | Tokyo |
| Japan | Research Site | Fujioka city | Gunma Prefecture |
| Japan | Research Site | Fujisawa city | Kanagawa Prefecture |
| Japan | Research Site | Fukuoka city | Fukuoka Prefecture |
| Japan | Research Site | Fukuoka city | Fukuoka Prefecture |
| Japan | Research Site | Fukuoka city | Fukuoka Prefecture |
| Japan | Research Site | Fukuyama city | Hiroshima Prefecture |
| Japan | Research Site | Futaba gun | Fukushima Prefecture |
| Japan | Research Site | Gobo city | Wakayama Prefecture |
| Japan | Research Site | Hachioji city | Tokyo |
| Japan | Research Site | Hachioji city | Tokyo |
| Japan | Research Site | Hamada city | Shimane Prefecture |
| Japan | Research Site | Higashihiroshima city | Hiroshima Prefecture |
| Japan | Research Site | Higashiibaraki Gun | Ibaraki Prefecture |
| Japan | Research Site | Higashikurume city | Tokyo Prefecture |
| Japan | Research Site | Himeji city | Hyogo Prefectural |
| Japan | Research Site | Hiroshima city | Hiroshima Prefecture |
| Japan | Research Site | Hitachi city | Ibaraki Prefecture |
| Japan | Research Site | Ichihara city | Chiba Prefecture |
| Japan | Research Site | Ichikawa city | Chiba Prefecture |
| Japan | Research Site | Ichinomiya city | Aichi Prefecture |
| Japan | Research Site | Ichinomiya city | Aichi Prefecture |
| Japan | Research Site | Inuyama city | Aichi Prefecture |
| Japan | Research Site | Ise city | Mie Prefecture |
| Japan | Research Site | Itoshima city | Fukuoka Prefecture |
| Japan | Research Site | Iwaki city | Fukushima Prefecture |
| Japan | Research Site | Iwamizawa city | Hokkaido |
| Japan | Research Site | Izumisano city | Osaka Prefecture |
| Japan | Research Site | Kagoshima city | Kagoshima Prefecture |
| Japan | Research Site | Kagoshima city | Kagoshima Prefecture |
| Japan | Research Site | Kahoku gun | Ishikawa Prefecture |
| Japan | Research Site | Kanazawa city | Ishikawa Prefecture |
| Japan | Research Site | Kanazawa city | Ishikawa Prefecture |
| Japan | Research Site | Kanazawa city | Ishikawa Prefecture |
| Japan | Research Site | Kanazawa city | Ishikawa Prefecture |
| Japan | Research Site | Kani city | Gifu Prefecture |
| Japan | Research Site | Kanoya city | Kagoshima Prefecture |
| Japan | Research Site | Kasugai city | Aichi Prefecture |
| Japan | Research Site | Kawachinagano City | Osaka Prefecture |
| Japan | Research Site | Kawasaki city | Kanagawa Prefecture |
| Japan | Research Site | Kawasaki city | Kanagawa Prefecture |
| Japan | Research Site | Kiryu city | Gunma Prefecture |
| Japan | Research Site | Kisarazu city | Chiba Prefecture |
| Japan | Research Site | Kita gun | Kagawa Prefecture |
| Japan | Research Site | Kitakami city | Iwate Prefecture |
| Japan | Research Site | Kitakyushu city | Fukuoka Prefecture |
| Japan | Research Site | Kitakyushu city | Fukuoka Prefecture |
| Japan | Research Site | Kobe city | Hyogo Prefecture |
| Japan | Research Site | Kobe city | Hyogo Prefecture |
| Japan | Research Site | Kobe city | Hyogo Prefecture |
| Japan | Research Site | Kobe city | Hyogo Prefecture |
| Japan | Research Site | Kobe city | Hyogo Prefectural |
| Japan | Research Site | Kobe city | Hyogo Prefectural |
| Japan | Research Site | Kodaira city | Tokyo |
| Japan | Research Site | Kofu city | Yamanashi Prefecture |
| Japan | Research Site | Komaki city | Aichi Prefecture |
| Japan | Research Site | Koriyama city | Fukushima Prefecture |
| Japan | Research Site | Koshigaya city | Saitama Prefecture |
| Japan | Research Site | Kumamoto city | Kumamoto Prefecture |
| Japan | Research Site | Kumamoto city | Kumamoto Prefecture |
| Japan | Research Site | Kyoto city | Kyoto Prefecture |
| Japan | Research Site | Kyoto city | Kyoto Prefecture |
| Japan | Research Site | Maizuru city | Kyoto Prefecture |
| Japan | Research Site | Matsudo city | Chiba Prefecture |
| Japan | Research Site | Matsumoto city | Nagano Prefecture |
| Japan | Research Site | Matsuyama city | Ehime Prefecture |
| Japan | Research Site | Mino city | Gifu Prefecture |
| Japan | Research Site | Mito city | Ibaraki Prefecture |
| Japan | Research Site | Miura city | Kanagawa Prefecture |
| Japan | Research Site | Miyazaki city | Miyazaki Prefecture |
| Japan | Research Site | Morioka city | Iwate Prefecture |
| Japan | Research Site | Moriyama city | Shiga Prefecture |
| Japan | Research Site | Nagahama city | Gifu Prefecture |
| Japan | Research Site | Nagoya city | Aichi Prefecture |
| Japan | Research Site | Nagoya city | Aichi Prefecture |
| Japan | Research Site | Nagoya city | Aichi Prefecture |
| Japan | Research Site | Nagoya city | Aichi Prefecture |
| Japan | Research Site | Nagoya city | Aichi Prefecture |
| Japan | Research Site | Nagoya city | Aichi Prefecture |
| Japan | Research Site | Nagoya city | Aichi Prefecture |
| Japan | Research Site | Niigata city | Niigata Prefecture |
| Japan | Research Site | Nikko city | Tochigi Prefecture |
| Japan | Research Site | Oita city | Oita Prefecture |
| Japan | Research Site | Okayama city | Okayama Prefecture |
| Japan | Research Site | Okayama city | Okayama Prefecture |
| Japan | Research Site | Okayama city | Okayama Prefecture |
| Japan | Research Site | Okayama city | Okayama Prefecture |
| Japan | Research Site | Omuta city | Fukuoka Prefecture |
| Japan | Research Site | Onomichi city | Hiroshima Prefecture |
| Japan | Research Site | Osaka city | Osaka Prefecture |
| Japan | Research Site | Osaka city | Osaka Prefecture |
| Japan | Research Site | Osaka city | Osaka Prefecture |
| Japan | Research Site | Ota ku | Tokyo |
| Japan | Research Site | Saga city | Saga Prefecture |
| Japan | Research Site | Saitama city | Saitama Prefecture |
| Japan | Research Site | Saitama city | Saitama Prefecture |
| Japan | Research Site | Sakaide City | Kagawa Prefecture |
| Japan | Research Site | Sanda city | Hyogo Prefectural |
| Japan | Research Site | Sapporo city | Hokkaido |
| Japan | Research Site | Sapporo city | Hokkaido |
| Japan | Research Site | Sapporo city | Hokkaido |
| Japan | Research Site | Sapporo city | Hokkaido |
| Japan | Research Site | Sendai city | Miyagi Prefecture |
| Japan | Research Site | Shibuyaku | Tokyo |
| Japan | Research Site | Shinagawa City | Tokyo Prefecture |
| Japan | Research Site | Shingu city | Wakayama Prefecture |
| Japan | Research Site | Sinagawa Ku | Tokyo |
| Japan | Research Site | Suita city | Osaka Prefecture |
| Japan | Research Site | Suita city | Osaka Prefecture |
| Japan | Research Site | Suita city | Osaka Prefecture |
| Japan | Research Site | Taitoku | Tokyo |
| Japan | Research Site | Takaishi city | Osaka Prefecture |
| Japan | Research Site | Takasaki | Gunma Prefecture |
| Japan | Research Site | Takasaki city | Gunma Prefecture |
| Japan | Research Site | Takatsuki city | Osaka Prefecture |
| Japan | Research Site | Taku city | Saga Prefecture |
| Japan | Research Site | Tokushima city | Tokushima Prefecture |
| Japan | Research Site | Toshimaku | Tokyo |
| Japan | Research Site | Tsu city | Mie Prefecture |
| Japan | Research Site | Tsushima city | Aichi Prefecture |
| Japan | Research Site | Uchinada | Ishikawa Prefecture |
| Japan | Research Site | Uji city | Kyoto Prefecture |
| Japan | Research Site | Wakayama city | Wakayama Prefecture |
| Japan | Research Site | Wakayama city | Wakayama Prefecture |
| Japan | Research Site | Yamaga city | Kumamoto Prefecture |
| Japan | Research Site | Yokohama city | Kanagawa Prefecture |
| Japan | Research Site | Yokohama city | Kanagawa Prefecture |
| Japan | Research Site | Yokohama city | Kanagawa Prefecture |
| Japan | Research Site | Yokosuka city | Kanagawa Prefecture |
| Japan | Research Site | Yokosuka city | Kanagawa Prefecture |
| Japan | Research Site | Yokosuka city | Kanagawa Prefecture |
| Japan | Research Site | Yosa Gun | Kyoto Prefecture |
| Japan | Research Site | Yuzawa city | Akita Prefecture |
| Japan | Research Site | Zentsuji City | Kagawa Prefecture |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of adverse events and adverse drug reactions | The incidence of adverse events and drug reactions will be described using the same units (events per 1000 person-years). Adverse events (including seriousness and causal relations to drug or device), inclusive of reaction at local injection sites, and other safety information (e.g. overdose, lack of effectiveness, pregnancy and lactation with or without adverse event) will be described. | 2 years | |
| Primary | Laboratory values for LDL-C | 2 years | ||
| Primary | Laboratory values for HDL-C | 2 years | ||
| Primary | Laboratory values for total cholesterol | 2 years | ||
| Primary | Laboratory values for triglycerides | 2 years | ||
| Primary | Laboratory values for Apolipoprotein (Apo) A1 | This will be measured if feasible. | 2 years | |
| Primary | Laboratory values for Apolipoprotein (Apo) Apo B | This will be measured if feasible. | 2 years | |
| Primary | Laboratory values for Apolipoprotein (Apo) Apo E | This will be measured if feasible. | 2 years | |
| Primary | Laboratory values for lipoprotein(a) | This will be measured if feasible. | 2 years |
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