Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan
Sponsor
Amgen (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02808403
Collaborator
(none)
6,000
139
81.2
43.2
0.5
Study Details
Study Description
Brief Summary
The purpose of this post-marketing survey is to obtain real-world information on the safety and effectiveness of evolocumab in Japan.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Study Type:
Observational
Actual Enrollment
:
6000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab (AMG 145) in Japan
Actual Study Start Date
:
Jun 24, 2016
Anticipated Primary Completion Date
:
Oct 31, 2022
Anticipated Study Completion Date
:
Mar 31, 2023
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Incidence of adverse events and adverse drug reactions [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.
- Laboratory values for LDL-C [2 years]
- Laboratory values for HDL-C [2 years]
- Laboratory values for total cholesterol [2 years]
- Laboratory values for triglycerides [2 years]
- Laboratory values for Apolipoprotein (Apo) A1 [2 years]
This will be measured if feasible.
- Laboratory values for Apolipoprotein (Apo) Apo B [2 years]
This will be measured if feasible.
- Laboratory values for Apolipoprotein (Apo) Apo E [2 years]
This will be measured if feasible.
- Laboratory values for lipoprotein(a) [2 years]
This will be measured if feasible.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Ichinomiya city | Aichi Prefecture | Japan | 491-0911 |
| 2 | Research Site | Ichinomiya city | Aichi Prefecture | Japan | 494-0001 |
| 3 | Research Site | Inuyama city | Aichi Prefecture | Japan | 484-0074 |
| 4 | Research Site | Kasugai city | Aichi Prefecture | Japan | 487-0016 |
| 5 | Research Site | Komaki city | Aichi Prefecture | Japan | 485-0000 |
| 6 | Research Site | Nagoya city | Aichi Prefecture | Japan | 454-0933 |
| 7 | Research Site | Nagoya city | Aichi Prefecture | Japan | 455-8530 |
| 8 | Research Site | Nagoya city | Aichi Prefecture | Japan | 457-0047 |
| 9 | Research Site | Nagoya city | Aichi Prefecture | Japan | 457-8511 |
| 10 | Research Site | Nagoya city | Aichi Prefecture | Japan | 465-0094 |
| 11 | Research Site | Nagoya city | Aichi Prefecture | Japan | 466-0815 |
| 12 | Research Site | Nagoya city | Aichi Prefecture | Japan | 466-8560 |
| 13 | Research Site | Tsushima city | Aichi Prefecture | Japan | 496-8537 |
| 14 | Research Site | Akita city | Akita Prefecture | Japan | 010-1423 |
| 15 | Research Site | Yuzawa city | Akita Prefecture | Japan | 012-0037 |
| 16 | Research Site | Asahi city | Chiba Prefecture | Japan | 289-2511 |
| 17 | Research Site | Chiba City | Chiba Prefecture | Japan | 260-8677 |
| 18 | Research Site | Chosei Gun | Chiba Prefecture | Japan | 297-0203 |
| 19 | Research Site | Ichihara city | Chiba Prefecture | Japan | 299-0111 |
| 20 | Research Site | Ichikawa city | Chiba Prefecture | Japan | 272-0103 |
| 21 | Research Site | Kisarazu city | Chiba Prefecture | Japan | 292-0038 |
| 22 | Research Site | Matsudo city | Chiba Prefecture | Japan | 270-2232 |
| 23 | Research Site | Matsuyama city | Ehime Prefecture | Japan | 791-8026 |
| 24 | Research Site | Fukuoka city | Fukuoka Prefecture | Japan | 810-0001 |
| 25 | Research Site | Fukuoka city | Fukuoka Prefecture | Japan | 812-8582 |
| 26 | Research Site | Fukuoka city | Fukuoka Prefecture | Japan | 815-8588 |
| 27 | Research Site | Itoshima city | Fukuoka Prefecture | Japan | 819-1104 |
| 28 | Research Site | Kitakyushu city | Fukuoka Prefecture | Japan | 802-0001 |
| 29 | Research Site | Kitakyushu city | Fukuoka Prefecture | Japan | 807-8556 |
| 30 | Research Site | Omuta city | Fukuoka Prefecture | Japan | 837-0916 |
| 31 | Research Site | Futaba gun | Fukushima Prefecture | Japan | 979-0403 |
| 32 | Research Site | Iwaki city | Fukushima Prefecture | Japan | 973-8555 |
| 33 | Research Site | Koriyama city | Fukushima Prefecture | Japan | 963-8501 |
| 34 | Research Site | Kani city | Gifu Prefecture | Japan | 509-0214 |
| 35 | Research Site | Mino city | Gifu Prefecture | Japan | 501-3732 |
| 36 | Research Site | Nagahama city | Gifu Prefecture | Japan | 526-8580 |
| 37 | Research Site | Fujioka city | Gunma Prefecture | Japan | 375-0024 |
| 38 | Research Site | Kiryu city | Gunma Prefecture | Japan | 376-0011 |
| 39 | Research Site | Takasaki city | Gunma Prefecture | Japan | 370-3513 |
| 40 | Research Site | Takasaki | Gunma Prefecture | Japan | 370-3513 |
| 41 | Research Site | Fukuyama city | Hiroshima Prefecture | Japan | 720-0001 |
| 42 | Research Site | Higashihiroshima city | Hiroshima Prefecture | Japan | 739-2104 |
| 43 | Research Site | Hiroshima city | Hiroshima Prefecture | Japan | 734-8551 |
| 44 | Research Site | Onomichi city | Hiroshima Prefecture | Japan | 722-8508 |
| 45 | Research Site | Iwamizawa city | Hokkaido | Japan | 068-8555 |
| 46 | Research Site | Sapporo city | Hokkaido | Japan | 002-8072 |
| 47 | Research Site | Sapporo city | Hokkaido | Japan | 060-0031 |
| 48 | Research Site | Sapporo city | Hokkaido | Japan | 062-0003 |
| 49 | Research Site | Sapporo city | Hokkaido | Japan | 065-0027 |
| 50 | Research Site | Himeji city | Hyogo Prefectural | Japan | 671-1227 |
| 51 | Research Site | Kobe city | Hyogo Prefectural | Japan | 651-1145 |
| 52 | Research Site | Kobe city | Hyogo Prefectural | Japan | 651-1351 |
| 53 | Research Site | Sanda city | Hyogo Prefectural | Japan | 669-1321 |
| 54 | Research Site | Kobe city | Hyogo Prefecture | Japan | 651-1321 |
| 55 | Research Site | Kobe city | Hyogo Prefecture | Japan | 654-0155 |
| 56 | Research Site | Kobe city | Hyogo Prefecture | Japan | 658-0032 |
| 57 | Research Site | Kobe city | Hyogo Prefecture | Japan | 658-0072 |
| 58 | Research Site | Higashiibaraki Gun | Ibaraki Prefecture | Japan | 311-3193 |
| 59 | Research Site | Hitachi city | Ibaraki Prefecture | Japan | 317-0077 |
| 60 | Research Site | Mito city | Ibaraki Prefecture | Japan | 310-0004 |
| 61 | Research Site | Kahoku gun | Ishikawa Prefecture | Japan | 920-0293 |
| 62 | Research Site | Kanazawa city | Ishikawa Prefecture | Japan | 920-0353 |
| 63 | Research Site | Kanazawa city | Ishikawa Prefecture | Japan | 920-8530 |
| 64 | Research Site | Kanazawa city | Ishikawa Prefecture | Japan | 920-8641 |
| 65 | Research Site | Kanazawa city | Ishikawa Prefecture | Japan | 921-8035 |
| 66 | Research Site | Uchinada | Ishikawa Prefecture | Japan | 920-0293 |
| 67 | Research Site | Kitakami city | Iwate Prefecture | Japan | 024-0021 |
| 68 | Research Site | Morioka city | Iwate Prefecture | Japan | 020-0066 |
| 69 | Research Site | Kita gun | Kagawa Prefecture | Japan | 761-0793 |
| 70 | Research Site | Sakaide City | Kagawa Prefecture | Japan | 762-8550 |
| 71 | Research Site | Zentsuji City | Kagawa Prefecture | Japan | 765-8507 |
| 72 | Research Site | Kagoshima city | Kagoshima Prefecture | Japan | 890-8760 |
| 73 | Research Site | Kagoshima city | Kagoshima Prefecture | Japan | 892-0828 |
| 74 | Research Site | Kanoya city | Kagoshima Prefecture | Japan | 893-0013 |
| 75 | Research Site | Fujisawa city | Kanagawa Prefecture | Japan | 251-0003 |
| 76 | Research Site | Kawasaki city | Kanagawa Prefecture | Japan | 210-0013 |
| 77 | Research Site | Kawasaki city | Kanagawa Prefecture | Japan | 214-0014 |
| 78 | Research Site | Miura city | Kanagawa Prefecture | Japan | 238-0101 |
| 79 | Research Site | Yokohama city | Kanagawa Prefecture | Japan | 231-0806 |
| 80 | Research Site | Yokohama city | Kanagawa Prefecture | Japan | 236-0037 |
| 81 | Research Site | Yokohama city | Kanagawa Prefecture | Japan | 247-8581 |
| 82 | Research Site | Yokosuka city | Kanagawa Prefecture | Japan | 238-8558 |
| 83 | Research Site | Yokosuka city | Kanagawa Prefecture | Japan | 238-8567 |
| 84 | Research Site | Yokosuka city | Kanagawa Prefecture | Japan | 240-0195 |
| 85 | Research Site | Kumamoto city | Kumamoto Prefecture | Japan | 860-8515 |
| 86 | Research Site | Kumamoto city | Kumamoto Prefecture | Japan | 860-8556 |
| 87 | Research Site | Yamaga city | Kumamoto Prefecture | Japan | 861-0517 |
| 88 | Research Site | Kyoto city | Kyoto Prefecture | Japan | 602-8566 |
| 89 | Research Site | Kyoto city | Kyoto Prefecture | Japan | 615-0812 |
| 90 | Research Site | Maizuru city | Kyoto Prefecture | Japan | 625-8585 |
| 91 | Research Site | Uji city | Kyoto Prefecture | Japan | 611-0041 |
| 92 | Research Site | Yosa Gun | Kyoto Prefecture | Japan | 629-2261 |
| 93 | Research Site | Ise city | Mie Prefecture | Japan | 516-8512 |
| 94 | Research Site | Tsu city | Mie Prefecture | Japan | 514-8507 |
| 95 | Research Site | Sendai city | Miyagi Prefecture | Japan | 980-8574 |
| 96 | Research Site | Miyazaki city | Miyazaki Prefecture | Japan | 880-0924 |
| 97 | Research Site | Matsumoto city | Nagano Prefecture | Japan | 390-8621 |
| 98 | Research Site | Niigata city | Niigata Prefecture | Japan | 950-0165 |
| 99 | Research Site | Oita city | Oita Prefecture | Japan | 879-7761 |
| 100 | Research Site | Okayama city | Okayama Prefecture | Japan | 700-0804 |
| 101 | Research Site | Okayama city | Okayama Prefecture | Japan | 700-8505 |
| 102 | Research Site | Okayama city | Okayama Prefecture | Japan | 700-8558 |
| 103 | Research Site | Okayama city | Okayama Prefecture | Japan | 703-8265 |
| 104 | Research Site | Izumisano city | Osaka Prefecture | Japan | 598-8577 |
| 105 | Research Site | Kawachinagano City | Osaka Prefecture | Japan | 586-8521 |
| 106 | Research Site | Osaka city | Osaka Prefecture | Japan | 533-0003 |
| 107 | Research Site | Osaka city | Osaka Prefecture | Japan | 537-8511 |
| 108 | Research Site | Osaka city | Osaka Prefecture | Japan | 543-0011 |
| 109 | Research Site | Suita city | Osaka Prefecture | Japan | 564-0013 |
| 110 | Research Site | Suita city | Osaka Prefecture | Japan | 565-0871 |
| 111 | Research Site | Suita city | Osaka Prefecture | Japan | 565-8565 |
| 112 | Research Site | Takaishi city | Osaka Prefecture | Japan | 592-0014 |
| 113 | Research Site | Takatsuki city | Osaka Prefecture | Japan | 569-8585 |
| 114 | Research Site | Saga city | Saga Prefecture | Japan | 840-0862 |
| 115 | Research Site | Taku city | Saga Prefecture | Japan | 844-0002 |
| 116 | Research Site | Ageo city | Saitama Prefecture | Japan | 362-8588 |
| 117 | Research Site | Koshigaya city | Saitama Prefecture | Japan | 343-8555 |
| 118 | Research Site | Saitama city | Saitama Prefecture | Japan | 330-0855 |
| 119 | Research Site | Saitama city | Saitama Prefecture | Japan | 339-0033 |
| 120 | Research Site | Moriyama city | Shiga Prefecture | Japan | 524-8524 |
| 121 | Research Site | Hamada city | Shimane Prefecture | Japan | 697-8511 |
| 122 | Research Site | Nikko city | Tochigi Prefecture | Japan | 321-2593 |
| 123 | Research Site | Tokushima city | Tokushima Prefecture | Japan | 770-8503 |
| 124 | Research Site | Higashikurume city | Tokyo Prefecture | Japan | 203-0043 |
| 125 | Research Site | Shinagawa City | Tokyo Prefecture | Japan | 141-0001 |
| 126 | Research Site | Chuoku | Tokyo | Japan | 104-8560 |
| 127 | Research Site | Hachioji city | Tokyo | Japan | 192-0918 |
| 128 | Research Site | Hachioji city | Tokyo | Japan | 193-0998 |
| 129 | Research Site | Kodaira city | Tokyo | Japan | 187-0003 |
| 130 | Research Site | Ota ku | Tokyo | Japan | 146-8531 |
| 131 | Research Site | Shibuyaku | Tokyo | Japan | 150-8935 |
| 132 | Research Site | Sinagawa Ku | Tokyo | Japan | 140-8522 |
| 133 | Research Site | Taitoku | Tokyo | Japan | 111-0053 |
| 134 | Research Site | Toshimaku | Tokyo | Japan | 171-0014 |
| 135 | Research Site | Gobo city | Wakayama Prefecture | Japan | 644-0002 |
| 136 | Research Site | Shingu city | Wakayama Prefecture | Japan | 647-0072 |
| 137 | Research Site | Wakayama city | Wakayama Prefecture | Japan | 640-8505 |
| 138 | Research Site | Wakayama city | Wakayama Prefecture | Japan | 640-8558 |
| 139 | Research Site | Kofu city | Yamanashi Prefecture | Japan | 400-8506 |
Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT02808403
Other Study ID Numbers:
- 20140409
First Posted:
Jun 21, 2016
Last Update Posted:
May 11, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms: