Clinical trial NCT02808403: Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan
Official title: Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab (AMG 145) in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Familial Hypercholesterolemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-06-21
Enrollment: 6000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients for whom evolocumab is prescribed at participating medical institutions in accordance with the approved Japan prescribing information (i.e., those with Familial Hypercholesterolemia and Hypercholesterolemia who have high risk factors for cardiovascular event and do not respond sufficiently to Hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) for hypercholesterolemia.)

Brief summary: The purpose of this post-marketing survey is to obtain real-world information on the safety and effectiveness of evolocumab in Japan.

Detailed description: The objectives of study are to 1) determine the incidence of adverse events and adverse drug reactions among patients receiving evolocumab for up to 2 years, and 2) identify and describe patient characteristics (e.g. demographics, medical history) associated with the safety and effectiveness of evolocumab therapy for the patients with Familial Hypercholesterolemia (Heterozygous or Homozygous) and Hypercholesterolemia in Japan

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse events and adverse drug reactions
timeFrame: 2 years
measure: Laboratory values for LDL-C
timeFrame: 2 years
measure: Laboratory values for HDL-C
timeFrame: 2 years
measure: Laboratory values for total cholesterol
timeFrame: 2 years
measure: Laboratory values for triglycerides
timeFrame: 2 years
measure: Laboratory values for Apolipoprotein (Apo) A1
timeFrame: 2 years
measure: Laboratory values for Apolipoprotein (Apo) Apo B
timeFrame: 2 years
measure: Laboratory values for Apolipoprotein (Apo) Apo E
timeFrame: 2 years
measure: Laboratory values for lipoprotein(a)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ichinomiya city
country: Japan
facility: Research Site
state: Aichi Prefecture
city: Ichinomiya city
country: Japan
facility: Research Site
state: Aichi Prefecture
city: Inuyama city
country: Japan
facility: Research Site
state: Aichi Prefecture
city: Kasugai city
country: Japan
facility: Research Site
state: Aichi Prefecture
city: Komaki city
country: Japan
facility: Research Site
state: Aichi Prefecture
city: Nagoya city
country: Japan
facility: Research Site
state: Aichi Prefecture
city: Nagoya city
country: Japan
facility: Research Site
state: Aichi Prefecture
city: Nagoya city
country: Japan
facility: Research Site
state: Aichi Prefecture
city: Nagoya city
country: Japan
facility: Research Site
state: Aichi Prefecture
city: Nagoya city
country: Japan
facility: Research Site
state: Aichi Prefecture
city: Nagoya city
country: Japan
facility: Research Site
state: Aichi Prefecture
city: Nagoya city
country: Japan
facility: Research Site
state: Aichi Prefecture
city: Tsushima city
country: Japan
facility: Research Site
state: Aichi Prefecture
city: Akita city
country: Japan
facility: Research Site
state: Akita Prefecture
city: Yuzawa city
country: Japan
facility: Research Site
state: Akita Prefecture
city: Asahi city
country: Japan
facility: Research Site
state: Chiba Prefecture
city: Chiba City
country: Japan
facility: Research Site
state: Chiba Prefecture
city: Chosei Gun
country: Japan
facility: Research Site
state: Chiba Prefecture
city: Ichihara city
country: Japan
facility: Research Site
state: Chiba Prefecture
city: Ichikawa city
country: Japan
facility: Research Site
state: Chiba Prefecture
city: Kisarazu city
country: Japan
facility: Research Site
state: Chiba Prefecture
city: Matsudo city
country: Japan
facility: Research Site
state: Chiba Prefecture
city: Matsuyama city
country: Japan
facility: Research Site
state: Ehime Prefecture
city: Fukuoka city
country: Japan
facility: Research Site
state: Fukuoka Prefecture
city: Fukuoka city
country: Japan
facility: Research Site
state: Fukuoka Prefecture
city: Fukuoka city
country: Japan
facility: Research Site
state: Fukuoka Prefecture
city: Itoshima city
country: Japan
facility: Research Site
state: Fukuoka Prefecture
city: Kitakyushu city
country: Japan
facility: Research Site
state: Fukuoka Prefecture
city: Kitakyushu city
country: Japan
facility: Research Site
state: Fukuoka Prefecture
city: Omuta city
country: Japan
facility: Research Site
state: Fukuoka Prefecture
city: Futaba gun
country: Japan
facility: Research Site
state: Fukushima Prefecture
city: Iwaki city
country: Japan
facility: Research Site
state: Fukushima Prefecture
city: Koriyama city
country: Japan
facility: Research Site
state: Fukushima Prefecture
city: Kani city
country: Japan
facility: Research Site
state: Gifu Prefecture
city: Mino city
country: Japan
facility: Research Site
state: Gifu Prefecture
city: Nagahama city
country: Japan
facility: Research Site
state: Gifu Prefecture
city: Fujioka city
country: Japan
facility: Research Site
state: Gunma Prefecture
city: Kiryu city
country: Japan
facility: Research Site
state: Gunma Prefecture
city: Takasaki city
country: Japan
facility: Research Site
state: Gunma Prefecture
city: Takasaki
country: Japan
facility: Research Site
state: Gunma Prefecture
city: Fukuyama city
country: Japan
facility: Research Site
state: Hiroshima Prefecture
city: Higashihiroshima city
country: Japan
facility: Research Site
state: Hiroshima Prefecture
city: Hiroshima city
country: Japan
facility: Research Site
state: Hiroshima Prefecture
city: Onomichi city
country: Japan
facility: Research Site
state: Hiroshima Prefecture
city: Iwamizawa city
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo city
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo city
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo city
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo city
country: Japan
facility: Research Site
state: Hokkaido
city: Himeji city
country: Japan
facility: Research Site
state: Hyogo Prefectural
city: Kobe city
country: Japan
facility: Research Site
state: Hyogo Prefectural
city: Kobe city
country: Japan
facility: Research Site
state: Hyogo Prefectural
city: Sanda city
country: Japan
facility: Research Site
state: Hyogo Prefectural
city: Kobe city
country: Japan
facility: Research Site
state: Hyogo Prefecture
city: Kobe city
country: Japan
facility: Research Site
state: Hyogo Prefecture
city: Kobe city
country: Japan
facility: Research Site
state: Hyogo Prefecture
city: Kobe city
country: Japan
facility: Research Site
state: Hyogo Prefecture
city: Higashiibaraki Gun
country: Japan
facility: Research Site
state: Ibaraki Prefecture
city: Hitachi city
country: Japan
facility: Research Site
state: Ibaraki Prefecture
city: Mito city
country: Japan
facility: Research Site
state: Ibaraki Prefecture
city: Kahoku gun
country: Japan
facility: Research Site
state: Ishikawa Prefecture
city: Kanazawa city
country: Japan
facility: Research Site
state: Ishikawa Prefecture
city: Kanazawa city
country: Japan
facility: Research Site
state: Ishikawa Prefecture
city: Kanazawa city
country: Japan
facility: Research Site
state: Ishikawa Prefecture
city: Kanazawa city
country: Japan
facility: Research Site
state: Ishikawa Prefecture
city: Uchinada
country: Japan
facility: Research Site
state: Ishikawa Prefecture
city: Kitakami city
country: Japan
facility: Research Site
state: Iwate Prefecture
city: Morioka city
country: Japan
facility: Research Site
state: Iwate Prefecture
city: Kita gun
country: Japan
facility: Research Site
state: Kagawa Prefecture
city: Sakaide City
country: Japan
facility: Research Site
state: Kagawa Prefecture
city: Zentsuji City
country: Japan
facility: Research Site
state: Kagawa Prefecture
city: Kagoshima city
country: Japan
facility: Research Site
state: Kagoshima Prefecture
city: Kagoshima city
country: Japan
facility: Research Site
state: Kagoshima Prefecture
city: Kanoya city
country: Japan
facility: Research Site
state: Kagoshima Prefecture
city: Fujisawa city
country: Japan
facility: Research Site
state: Kanagawa Prefecture
city: Kawasaki city
country: Japan
facility: Research Site
state: Kanagawa Prefecture
city: Kawasaki city
country: Japan
facility: Research Site
state: Kanagawa Prefecture
city: Miura city
country: Japan
facility: Research Site
state: Kanagawa Prefecture
city: Yokohama city
country: Japan
facility: Research Site
state: Kanagawa Prefecture
city: Yokohama city
country: Japan
facility: Research Site
state: Kanagawa Prefecture
city: Yokohama city
country: Japan
facility: Research Site
state: Kanagawa Prefecture
city: Yokosuka city
country: Japan
facility: Research Site
state: Kanagawa Prefecture
city: Yokosuka city
country: Japan
facility: Research Site
state: Kanagawa Prefecture
city: Yokosuka city
country: Japan
facility: Research Site
state: Kanagawa Prefecture
city: Kumamoto city
country: Japan
facility: Research Site
state: Kumamoto Prefecture
city: Kumamoto city
country: Japan
facility: Research Site
state: Kumamoto Prefecture
city: Yamaga city
country: Japan
facility: Research Site
state: Kumamoto Prefecture
city: Kyoto city
country: Japan
facility: Research Site
state: Kyoto Prefecture
city: Kyoto city
country: Japan
facility: Research Site
state: Kyoto Prefecture
city: Maizuru city
country: Japan
facility: Research Site
state: Kyoto Prefecture
city: Uji city
country: Japan
facility: Research Site
state: Kyoto Prefecture
city: Yosa Gun
country: Japan
facility: Research Site
state: Kyoto Prefecture
city: Ise city
country: Japan
facility: Research Site
state: Mie Prefecture
city: Tsu city
country: Japan
facility: Research Site
state: Mie Prefecture
city: Sendai city
country: Japan
facility: Research Site
state: Miyagi Prefecture
city: Miyazaki city
country: Japan
facility: Research Site
state: Miyazaki Prefecture
city: Matsumoto city
country: Japan
facility: Research Site
state: Nagano Prefecture
city: Niigata city
country: Japan
facility: Research Site
state: Niigata Prefecture
city: Oita city
country: Japan
facility: Research Site
state: Oita Prefecture
city: Okayama city
country: Japan
facility: Research Site
state: Okayama Prefecture
city: Okayama city
country: Japan
facility: Research Site
state: Okayama Prefecture
city: Okayama city
country: Japan
facility: Research Site
state: Okayama Prefecture
city: Okayama city
country: Japan
facility: Research Site
state: Okayama Prefecture
city: Izumisano city
country: Japan
facility: Research Site
state: Osaka Prefecture
city: Kawachinagano City
country: Japan
facility: Research Site
state: Osaka Prefecture
city: Osaka city
country: Japan
facility: Research Site
state: Osaka Prefecture
city: Osaka city
country: Japan
facility: Research Site
state: Osaka Prefecture
city: Osaka city
country: Japan
facility: Research Site
state: Osaka Prefecture
city: Suita city
country: Japan
facility: Research Site
state: Osaka Prefecture
city: Suita city
country: Japan
facility: Research Site
state: Osaka Prefecture
city: Suita city
country: Japan
facility: Research Site
state: Osaka Prefecture
city: Takaishi city
country: Japan
facility: Research Site
state: Osaka Prefecture
city: Takatsuki city
country: Japan
facility: Research Site
state: Osaka Prefecture
city: Saga city
country: Japan
facility: Research Site
state: Saga Prefecture
city: Taku city
country: Japan
facility: Research Site
state: Saga Prefecture
city: Ageo city
country: Japan
facility: Research Site
state: Saitama Prefecture
city: Koshigaya city
country: Japan
facility: Research Site
state: Saitama Prefecture
city: Saitama city
country: Japan
facility: Research Site
state: Saitama Prefecture
city: Saitama city
country: Japan
facility: Research Site
state: Saitama Prefecture
city: Moriyama city
country: Japan
facility: Research Site
state: Shiga Prefecture
city: Hamada city
country: Japan
facility: Research Site
state: Shimane Prefecture
city: Nikko city
country: Japan
facility: Research Site
state: Tochigi Prefecture
city: Tokushima city
country: Japan
facility: Research Site
state: Tokushima Prefecture
city: Higashikurume city
country: Japan
facility: Research Site
state: Tokyo Prefecture
city: Shinagawa City
country: Japan
facility: Research Site
state: Tokyo Prefecture
city: Chuoku
country: Japan
facility: Research Site
state: Tokyo
city: Hachioji city
country: Japan
facility: Research Site
state: Tokyo
city: Hachioji city
country: Japan
facility: Research Site
state: Tokyo
city: Kodaira city
country: Japan
facility: Research Site
state: Tokyo
city: Ota ku
country: Japan
facility: Research Site
state: Tokyo
city: Shibuyaku
country: Japan
facility: Research Site
state: Tokyo
city: Sinagawa Ku
country: Japan
facility: Research Site
state: Tokyo
city: Taitoku
country: Japan
facility: Research Site
state: Tokyo
city: Toshimaku
country: Japan
facility: Research Site
state: Tokyo
city: Gobo city
country: Japan
facility: Research Site
state: Wakayama Prefecture
city: Shingu city
country: Japan
facility: Research Site
state: Wakayama Prefecture
city: Wakayama city
country: Japan
facility: Research Site
state: Wakayama Prefecture
city: Wakayama city
country: Japan
facility: Research Site
state: Wakayama Prefecture
city: Kofu city
country: Japan
facility: Research Site
state: Yamanashi Prefecture
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: