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

NCT02808403 | Completed

• 1 other identifier: 20140409
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 138

Brief Summary

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

Conditions

Hypercholesterolemia; Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (9)

• 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

• 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

  This will be measured if feasible.

  2 years

• Laboratory values for Apolipoprotein (Apo) Apo B

  This will be measured if feasible.

  2 years

• Laboratory values for Apolipoprotein (Apo) Apo E

  This will be measured if feasible.

  2 years

• Laboratory values for lipoprotein(a)

  This will be measured if feasible.

  2 years

Study Arms (1)

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

Interventions

No intervention OTHER

No intervention; observation of routine medical care

Evolocumab exposed

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.)

You may qualify if:

• 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).

Sponsors & Collaborators

• Amgen: lead

Study Sites (138)

Research Site

Ichinomiya, Aichi-ken, 491-0911, Japan

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Ichinomiya, Aichi-ken, 494-0001, Japan

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Inuyama, Aichi-ken, 484-0074, Japan

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Kasugai, Aichi-ken, 487-0016, Japan

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Komaki, Aichi-ken, 485-0000, Japan

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Nagoya, Aichi-ken, 454-0933, Japan

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Nagoya, Aichi-ken, 455-8530, Japan

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Nagoya, Aichi-ken, 457-0047, Japan

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Nagoya, Aichi-ken, 457-8511, Japan

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Nagoya, Aichi-ken, 465-0094, Japan

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Nagoya, Aichi-ken, 466-0815, Japan

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Nagoya, Aichi-ken, 466-8560, Japan

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Tsushima, Aichi-ken, 496-8537, Japan

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Akita, Akita, 010-1423, Japan

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Yuzawa, Akita, 012-0037, Japan

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Asahi, Chiba, 289-2511, Japan

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Chiba, Chiba, 260-8677, Japan

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Chosei Gun, Chiba, 297-0203, Japan

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Ichihara, Chiba, 299-0111, Japan

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Ichikawa, Chiba, 272-0103, Japan

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Kisarazu, Chiba, 292-0038, Japan

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Matsudo, Chiba, 270-2232, Japan

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Matsuyama, Ehime, 791-8026, Japan

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Fukuoka, Fukuoka, 810-0001, Japan

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Fukuoka, Fukuoka, 812-8582, Japan

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Fukuoka, Fukuoka, 815-8588, Japan

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Itoshima, Fukuoka, 819-1104, Japan

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Kitakyushu, Fukuoka, 802-0001, Japan

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Kitakyushu, Fukuoka, 807-8556, Japan

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Omuta, Fukuoka, 837-0916, Japan

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Futaba Gun, Fukushima, 979-0403, Japan

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Iwaki, Fukushima, 973-8555, Japan

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Kōriyama, Fukushima, 963-8501, Japan

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Kani, Gifu, 509-0214, Japan

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Mino, Gifu, 501-3732, Japan

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Nagahama City, Gifu, 526-8580, Japan

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Fujioka, Gunma, 375-0024, Japan

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Kiryū, Gunma, 376-0011, Japan

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Takasaki, Gunma, 370-3513, Japan

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Fukuyama, Hiroshima, 720-0001, Japan

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Higashihiroshima, Hiroshima, 739-2104, Japan

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Hiroshima, Hiroshima, 734-8551, Japan

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Onomichi, Hiroshima, 722-8508, Japan

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Iwamizawa, Hokkaido, 068-8555, Japan

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Sapporo, Hokkaido, 002-8072, Japan

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Sapporo, Hokkaido, 060-0031, Japan

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Sapporo, Hokkaido, 062-0003, Japan

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Sapporo, Hokkaido, 065-0027, Japan

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Himeji, Hyogo Prefectural, 671-1227, Japan

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Kobe, Hyogo Prefectural, 651-1145, Japan

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Kobe, Hyogo Prefectural, 651-1351, Japan

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Sanda, Hyogo Prefectural, 669-1321, Japan

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Kobe, Hyōgo, 651-1321, Japan

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Kobe, Hyōgo, 654-0155, Japan

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Kobe, Hyōgo, 658-0032, Japan

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Kobe, Hyōgo, 658-0072, Japan

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Higashiibaraki Gun, Ibaraki, 311-3193, Japan

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Hitachi, Ibaraki, 317-0077, Japan

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Mito, Ibaraki, 310-0004, Japan

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Kahoku Gun, Ishikawa-ken, 920-0293, Japan

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Kanazawa, Ishikawa-ken, 920-0353, Japan

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Kanazawa, Ishikawa-ken, 920-8530, Japan

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Kanazawa, Ishikawa-ken, 920-8641, Japan

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Kanazawa, Ishikawa-ken, 921-8035, Japan

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Mukai-awagasaki, Ishikawa-ken, 920-0293, Japan

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Kitakami, Iwate, 024-0021, Japan

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Morioka, Iwate, 020-0066, Japan

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Kita Gun, Kagawa-ken, 761-0793, Japan

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Sakaidechō, Kagawa-ken, 762-8550, Japan

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Zentsujichó, Kagawa-ken, 765-8507, Japan

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Kagoshima, Kagoshima-ken, 890-8760, Japan

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Kagoshima, Kagoshima-ken, 892-0828, Japan

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Kanoya, Kagoshima-ken, 893-0013, Japan

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Fujisawa, Kanagawa, 251-0003, Japan

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Kawasaki, Kanagawa, 210-0013, Japan

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Kawasaki, Kanagawa, 214-0014, Japan

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Miura, Kanagawa, 238-0101, Japan

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Yokohama, Kanagawa, 231-0806, Japan

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Yokohama, Kanagawa, 236-0037, Japan

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Yokohama, Kanagawa, 247-8581, Japan

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Yokosuka, Kanagawa, 238-8558, Japan

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Yokosuka, Kanagawa, 238-8567, Japan

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Yokosuka, Kanagawa, 240-0195, Japan

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Kumamoto, Kumamoto, 860-8515, Japan

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Kumamoto, Kumamoto, 860-8556, Japan

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Yamaga, Kumamoto, 861-0517, Japan

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Kyoto, Kyoto, 602-8566, Japan

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Kyoto, Kyoto, 615-0812, Japan

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Maizuru, Kyoto, 625-8585, Japan

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Uji, Kyoto, 611-0041, Japan

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Yosa Gun, Kyoto, 629-2261, Japan

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Ise, Mie-ken, 516-8512, Japan

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Tsu, Mie-ken, 514-8507, Japan

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Sendai, Miyagi, 980-8574, Japan

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Miyazaki, Miyazaki, 880-0924, Japan

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Matsumoto, Nagano, 390-8621, Japan

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Niigata, Niigata, 950-0165, Japan

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Ōita, Oita Prefecture, 879-7761, Japan

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Okayama, Okayama-ken, 700-0804, Japan

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Okayama, Okayama-ken, 700-8505, Japan

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Okayama, Okayama-ken, 700-8558, Japan

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Okayama, Okayama-ken, 703-8265, Japan

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Izumisano, Osaka, 598-8577, Japan

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Kawachi-Nagano, Osaka, 586-8521, Japan

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Osaka, Osaka, 533-0003, Japan

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Osaka, Osaka, 537-8511, Japan

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Osaka, Osaka, 543-0011, Japan

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Suita, Osaka, 564-0013, Japan

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Suita, Osaka, 565-0871, Japan

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Suita, Osaka, 565-8565, Japan

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Takaishi, Osaka, 592-0014, Japan

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Takatsuki, Osaka, 569-8585, Japan

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Saga, Saga-ken, 840-0862, Japan

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Taku, Saga-ken, 844-0002, Japan

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Ageo, Saitama, 362-8588, Japan

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Koshigaya, Saitama, 343-8555, Japan

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Saitama, Saitama, 330-0855, Japan

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Saitama, Saitama, 339-0033, Japan

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Moriyama, Shiga, 524-8524, Japan

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Hamada, Shimane, 697-8511, Japan

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Nikkō, Tochigi, 321-2593, Japan

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Tokushima, Tokushima, 770-8503, Japan

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Chuoku, Tokyo, 104-8560, Japan

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Hachiōji, Tokyo, 192-0918, Japan

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Hachiōji, Tokyo, 193-0998, Japan

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Higashikurume, Tokyo, 203-0043, Japan

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Kodaira, Tokyo, 187-0003, Japan

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Ōta-ku, Tokyo, 146-8531, Japan

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Shibuyaku, Tokyo, 150-8935, Japan

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Shinagawa City, Tokyo, 141-0001, Japan

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Sinagawa Ku, Tokyo, 140-8522, Japan

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Taitoku, Tokyo, 111-0053, Japan

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Toshimaku, Tokyo, 171-0014, Japan

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Gobō, Wakayama, 644-0002, Japan

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Shingū, Wakayama, 647-0072, Japan

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Wakayama, Wakayama, 640-8505, Japan

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Wakayama, Wakayama, 640-8558, Japan

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Kofu, Yamanashi, 400-8506, Japan

Location

Related Publications (1)

• Yokote K, Ako J, Kitagawa K, Osada N, Sheng F, Sonoda M, Teramoto T. Safety and Effectiveness of Low-Density Lipoprotein Cholesterol-Lowering Therapy With Evolocumab for Familial Hypercholesterolemia/Hypercholesterolemia in Japan: A Real-World, Postmarketing, Single-Arm Study. J Am Heart Assoc. 2024 Nov 5;13(21):e035809. doi: 10.1161/JAHA.124.035809. Epub 2024 Oct 29.

  PMID: 39470058 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 21, 2016
• Study Start: June 24, 2016
• Primary Completion: October 31, 2022
• Study Completion: March 30, 2023
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

JP (138)