Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan

April 6, 2023 updated by: Amgen

Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab (AMG 145) in Japan

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi Prefecture
      • Ichinomiya city, Aichi Prefecture, Japan, 491-0911
        • Research Site
      • Ichinomiya city, Aichi Prefecture, Japan, 494-0001
        • Research Site
      • Inuyama city, Aichi Prefecture, Japan, 484-0074
        • Research Site
      • Kasugai city, Aichi Prefecture, Japan, 487-0016
        • Research Site
      • Komaki city, Aichi Prefecture, Japan, 485-0000
        • Research Site
      • Nagoya city, Aichi Prefecture, Japan, 454-0933
        • Research Site
      • Nagoya city, Aichi Prefecture, Japan, 455-8530
        • Research Site
      • Nagoya city, Aichi Prefecture, Japan, 457-0047
        • Research Site
      • Nagoya city, Aichi Prefecture, Japan, 457-8511
        • Research Site
      • Nagoya city, Aichi Prefecture, Japan, 465-0094
        • Research Site
      • Nagoya city, Aichi Prefecture, Japan, 466-0815
        • Research Site
      • Nagoya city, Aichi Prefecture, Japan, 466-8560
        • Research Site
      • Tsushima city, Aichi Prefecture, Japan, 496-8537
        • Research Site
    • Akita Prefecture
      • Akita city, Akita Prefecture, Japan, 010-1423
        • Research Site
      • Yuzawa city, Akita Prefecture, Japan, 012-0037
        • Research Site
    • Chiba Prefecture
      • Asahi city, Chiba Prefecture, Japan, 289-2511
        • Research Site
      • Chiba City, Chiba Prefecture, Japan, 260-8677
        • Research Site
      • Chosei Gun, Chiba Prefecture, Japan, 297-0203
        • Research Site
      • Ichihara city, Chiba Prefecture, Japan, 299-0111
        • Research Site
      • Ichikawa city, Chiba Prefecture, Japan, 272-0103
        • Research Site
      • Kisarazu city, Chiba Prefecture, Japan, 292-0038
        • Research Site
      • Matsudo city, Chiba Prefecture, Japan, 270-2232
        • Research Site
    • Ehime Prefecture
      • Matsuyama city, Ehime Prefecture, Japan, 791-8026
        • Research Site
    • Fukuoka Prefecture
      • Fukuoka city, Fukuoka Prefecture, Japan, 810-0001
        • Research Site
      • Fukuoka city, Fukuoka Prefecture, Japan, 812-8582
        • Research Site
      • Fukuoka city, Fukuoka Prefecture, Japan, 815-8588
        • Research Site
      • Itoshima city, Fukuoka Prefecture, Japan, 819-1104
        • Research Site
      • Kitakyushu city, Fukuoka Prefecture, Japan, 802-0001
        • Research Site
      • Kitakyushu city, Fukuoka Prefecture, Japan, 807-8556
        • Research Site
      • Omuta city, Fukuoka Prefecture, Japan, 837-0916
        • Research Site
    • Fukushima Prefecture
      • Futaba gun, Fukushima Prefecture, Japan, 979-0403
        • Research Site
      • Iwaki city, Fukushima Prefecture, Japan, 973-8555
        • Research Site
      • Koriyama city, Fukushima Prefecture, Japan, 963-8501
        • Research Site
    • Gifu Prefecture
      • Kani city, Gifu Prefecture, Japan, 509-0214
        • Research Site
      • Mino city, Gifu Prefecture, Japan, 501-3732
        • Research Site
      • Nagahama city, Gifu Prefecture, Japan, 526-8580
        • Research Site
    • Gunma Prefecture
      • Fujioka city, Gunma Prefecture, Japan, 375-0024
        • Research Site
      • Kiryu city, Gunma Prefecture, Japan, 376-0011
        • Research Site
      • Takasaki, Gunma Prefecture, Japan, 370-3513
        • Research Site
      • Takasaki city, Gunma Prefecture, Japan, 370-3513
        • Research Site
    • Hiroshima Prefecture
      • Fukuyama city, Hiroshima Prefecture, Japan, 720-0001
        • Research Site
      • Higashihiroshima city, Hiroshima Prefecture, Japan, 739-2104
        • Research Site
      • Hiroshima city, Hiroshima Prefecture, Japan, 734-8551
        • Research Site
      • Onomichi city, Hiroshima Prefecture, Japan, 722-8508
        • Research Site
    • Hokkaido
      • Iwamizawa city, Hokkaido, Japan, 068-8555
        • Research Site
      • Sapporo city, Hokkaido, Japan, 002-8072
        • Research Site
      • Sapporo city, Hokkaido, Japan, 060-0031
        • Research Site
      • Sapporo city, Hokkaido, Japan, 062-0003
        • Research Site
      • Sapporo city, Hokkaido, Japan, 065-0027
        • Research Site
    • Hyogo Prefectural
      • Himeji city, Hyogo Prefectural, Japan, 671-1227
        • Research Site
      • Kobe city, Hyogo Prefectural, Japan, 651-1145
        • Research Site
      • Kobe city, Hyogo Prefectural, Japan, 651-1351
        • Research Site
      • Sanda city, Hyogo Prefectural, Japan, 669-1321
        • Research Site
    • Hyogo Prefecture
      • Kobe city, Hyogo Prefecture, Japan, 651-1321
        • Research Site
      • Kobe city, Hyogo Prefecture, Japan, 654-0155
        • Research Site
      • Kobe city, Hyogo Prefecture, Japan, 658-0032
        • Research Site
      • Kobe city, Hyogo Prefecture, Japan, 658-0072
        • Research Site
    • Ibaraki Prefecture
      • Higashiibaraki Gun, Ibaraki Prefecture, Japan, 311-3193
        • Research Site
      • Hitachi city, Ibaraki Prefecture, Japan, 317-0077
        • Research Site
      • Mito city, Ibaraki Prefecture, Japan, 310-0004
        • Research Site
    • Ishikawa Prefecture
      • Kahoku gun, Ishikawa Prefecture, Japan, 920-0293
        • Research Site
      • Kanazawa city, Ishikawa Prefecture, Japan, 920-0353
        • Research Site
      • Kanazawa city, Ishikawa Prefecture, Japan, 920-8530
        • Research Site
      • Kanazawa city, Ishikawa Prefecture, Japan, 920-8641
        • Research Site
      • Kanazawa city, Ishikawa Prefecture, Japan, 921-8035
        • Research Site
      • Uchinada, Ishikawa Prefecture, Japan, 920-0293
        • Research Site
    • Iwate Prefecture
      • Kitakami city, Iwate Prefecture, Japan, 024-0021
        • Research Site
      • Morioka city, Iwate Prefecture, Japan, 020-0066
        • Research Site
    • Kagawa Prefecture
      • Kita gun, Kagawa Prefecture, Japan, 761-0793
        • Research Site
      • Sakaide City, Kagawa Prefecture, Japan, 762-8550
        • Research Site
      • Zentsuji City, Kagawa Prefecture, Japan, 765-8507
        • Research Site
    • Kagoshima Prefecture
      • Kagoshima city, Kagoshima Prefecture, Japan, 890-8760
        • Research Site
      • Kagoshima city, Kagoshima Prefecture, Japan, 892-0828
        • Research Site
      • Kanoya city, Kagoshima Prefecture, Japan, 893-0013
        • Research Site
    • Kanagawa Prefecture
      • Fujisawa city, Kanagawa Prefecture, Japan, 251-0003
        • Research Site
      • Kawasaki city, Kanagawa Prefecture, Japan, 210-0013
        • Research Site
      • Kawasaki city, Kanagawa Prefecture, Japan, 214-0014
        • Research Site
      • Miura city, Kanagawa Prefecture, Japan, 238-0101
        • Research Site
      • Yokohama city, Kanagawa Prefecture, Japan, 231-0806
        • Research Site
      • Yokohama city, Kanagawa Prefecture, Japan, 236-0037
        • Research Site
      • Yokohama city, Kanagawa Prefecture, Japan, 247-8581
        • Research Site
      • Yokosuka city, Kanagawa Prefecture, Japan, 238-8558
        • Research Site
      • Yokosuka city, Kanagawa Prefecture, Japan, 238-8567
        • Research Site
      • Yokosuka city, Kanagawa Prefecture, Japan, 240-0195
        • Research Site
    • Kumamoto Prefecture
      • Kumamoto city, Kumamoto Prefecture, Japan, 860-8515
        • Research Site
      • Kumamoto city, Kumamoto Prefecture, Japan, 860-8556
        • Research Site
      • Yamaga city, Kumamoto Prefecture, Japan, 861-0517
        • Research Site
    • Kyoto Prefecture
      • Kyoto city, Kyoto Prefecture, Japan, 602-8566
        • Research Site
      • Kyoto city, Kyoto Prefecture, Japan, 615-0812
        • Research Site
      • Maizuru city, Kyoto Prefecture, Japan, 625-8585
        • Research Site
      • Uji city, Kyoto Prefecture, Japan, 611-0041
        • Research Site
      • Yosa Gun, Kyoto Prefecture, Japan, 629-2261
        • Research Site
    • Mie Prefecture
      • Ise city, Mie Prefecture, Japan, 516-8512
        • Research Site
      • Tsu city, Mie Prefecture, Japan, 514-8507
        • Research Site
    • Miyagi Prefecture
      • Sendai city, Miyagi Prefecture, Japan, 980-8574
        • Research Site
    • Miyazaki Prefecture
      • Miyazaki city, Miyazaki Prefecture, Japan, 880-0924
        • Research Site
    • Nagano Prefecture
      • Matsumoto city, Nagano Prefecture, Japan, 390-8621
        • Research Site
    • Niigata Prefecture
      • Niigata city, Niigata Prefecture, Japan, 950-0165
        • Research Site
    • Oita Prefecture
      • Oita city, Oita Prefecture, Japan, 879-7761
        • Research Site
    • Okayama Prefecture
      • Okayama city, Okayama Prefecture, Japan, 700-0804
        • Research Site
      • Okayama city, Okayama Prefecture, Japan, 700-8505
        • Research Site
      • Okayama city, Okayama Prefecture, Japan, 700-8558
        • Research Site
      • Okayama city, Okayama Prefecture, Japan, 703-8265
        • Research Site
    • Osaka Prefecture
      • Izumisano city, Osaka Prefecture, Japan, 598-8577
        • Research Site
      • Kawachinagano City, Osaka Prefecture, Japan, 586-8521
        • Research Site
      • Osaka city, Osaka Prefecture, Japan, 533-0003
        • Research Site
      • Osaka city, Osaka Prefecture, Japan, 537-8511
        • Research Site
      • Osaka city, Osaka Prefecture, Japan, 543-0011
        • Research Site
      • Suita city, Osaka Prefecture, Japan, 564-0013
        • Research Site
      • Suita city, Osaka Prefecture, Japan, 565-0871
        • Research Site
      • Suita city, Osaka Prefecture, Japan, 565-8565
        • Research Site
      • Takaishi city, Osaka Prefecture, Japan, 592-0014
        • Research Site
      • Takatsuki city, Osaka Prefecture, Japan, 569-8585
        • Research Site
    • Saga Prefecture
      • Saga city, Saga Prefecture, Japan, 840-0862
        • Research Site
      • Taku city, Saga Prefecture, Japan, 844-0002
        • Research Site
    • Saitama Prefecture
      • Ageo city, Saitama Prefecture, Japan, 362-8588
        • Research Site
      • Koshigaya city, Saitama Prefecture, Japan, 343-8555
        • Research Site
      • Saitama city, Saitama Prefecture, Japan, 330-0855
        • Research Site
      • Saitama city, Saitama Prefecture, Japan, 339-0033
        • Research Site
    • Shiga Prefecture
      • Moriyama city, Shiga Prefecture, Japan, 524-8524
        • Research Site
    • Shimane Prefecture
      • Hamada city, Shimane Prefecture, Japan, 697-8511
        • Research Site
    • Tochigi Prefecture
      • Nikko city, Tochigi Prefecture, Japan, 321-2593
        • Research Site
    • Tokushima Prefecture
      • Tokushima city, Tokushima Prefecture, Japan, 770-8503
        • Research Site
    • Tokyo
      • Chuoku, Tokyo, Japan, 104-8560
        • Research Site
      • Hachioji city, Tokyo, Japan, 192-0918
        • Research Site
      • Hachioji city, Tokyo, Japan, 193-0998
        • Research Site
      • Kodaira city, Tokyo, Japan, 187-0003
        • Research Site
      • Ota ku, Tokyo, Japan, 146-8531
        • Research Site
      • Shibuyaku, Tokyo, Japan, 150-8935
        • Research Site
      • Sinagawa Ku, Tokyo, Japan, 140-8522
        • Research Site
      • Taitoku, Tokyo, Japan, 111-0053
        • Research Site
      • Toshimaku, Tokyo, Japan, 171-0014
        • Research Site
    • Tokyo Prefecture
      • Higashikurume city, Tokyo Prefecture, Japan, 203-0043
        • Research Site
      • Shinagawa City, Tokyo Prefecture, Japan, 141-0001
        • Research Site
    • Wakayama Prefecture
      • Gobo city, Wakayama Prefecture, Japan, 644-0002
        • Research Site
      • Shingu city, Wakayama Prefecture, Japan, 647-0072
        • Research Site
      • Wakayama city, Wakayama Prefecture, Japan, 640-8505
        • Research Site
      • Wakayama city, Wakayama Prefecture, Japan, 640-8558
        • Research Site
    • Yamanashi Prefecture
      • Kofu city, Yamanashi Prefecture, Japan, 400-8506
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Evolocumab exposed
Patients for whom evolocumab is prescribed. Dosage, period (start/end date), frequency of injection (Every 2 weeks (Q2W), Every 4 weeks (Q4W)), drug withdrawal (Yes or No, date, reason) and injection site (upper arm, abdomen, thigh) of evolocumab will be collected.
Other: No intervention
No intervention; observation of routine medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events and adverse drug reactions
Time Frame: 2 years
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
Laboratory values for LDL-C
Time Frame: 2 years
2 years
Laboratory values for HDL-C
Time Frame: 2 years
2 years
Laboratory values for total cholesterol
Time Frame: 2 years
2 years
Laboratory values for triglycerides
Time Frame: 2 years
2 years
Laboratory values for Apolipoprotein (Apo) A1
Time Frame: 2 years
This will be measured if feasible.
2 years
Laboratory values for Apolipoprotein (Apo) Apo B
Time Frame: 2 years
This will be measured if feasible.
2 years
Laboratory values for Apolipoprotein (Apo) Apo E
Time Frame: 2 years
This will be measured if feasible.
2 years
Laboratory values for lipoprotein(a)
Time Frame: 2 years
This will be measured if feasible.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2016

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140409

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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