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

An observational study of Hypercholesterolemia and Familial Hypercholesterolemia, run by Amgen at 138 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Any age
Conditions the study is for: Hypercholesterolemia, Familial Hypercholesterolemia
Type of treatment: Injection or infusion
How many people: 6,000 participants
Where: 138 sitesJapan
Study dates: 24 Jun 2016to 30 Mar 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.)

Who may be able to join

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).

Who cannot join

No exclusion criteria are applied.

Trial locations and contacts

138 sites in 1 country.

City, postcode or hospital

138 sites in 1 country

Japan138 sites

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

Other trials in Japan

About this study

Official title: 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.

Read the 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

Conditions: Hypercholesterolemia, Familial Hypercholesterolemia
Being tested: No intervention
Medical subject headings: Hypercholesterolemia, Hyperlipoproteinemia Type II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No interventionOther
No intervention; observation of routine medical care

Study groups in NCT02808403
Study group	Role	What they receive
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. Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 years
Laboratory values for LDL-C
Measured: 2 years
Laboratory values for HDL-C
Measured: 2 years
Laboratory values for total cholesterol
Measured: 2 years
Laboratory values for triglycerides
Measured: 2 years
Laboratory values for Apolipoprotein (Apo) A1
This will be measured if feasible.
Measured: 2 years
Laboratory values for Apolipoprotein (Apo) Apo B
This will be measured if feasible.
Measured: 2 years
Laboratory values for Apolipoprotein (Apo) Apo E
This will be measured if feasible.
Measured: 2 years
Laboratory values for lipoprotein(a)
This will be measured if feasible.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jun 201630 Mar 2023

First posted21 Jun 2016 (estimated)
Study start24 Jun 2016
Primary completion31 Oct 2022
Study completion30 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 6,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02808403
Sponsor's protocol ID: 20140409
Status last verified: Nov 2024
First submitted: 7 Jun 2016
Last updated: 21 Nov 2024
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

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.
PubMed 39470058

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab (AMG 145) in Japan
ClinicalTrials.gov ID: NCT02808403
Acronym / sponsor ID: 20140409
Conditions: Hypercholesterolemia, Familial Hypercholesterolemia
Study type: Observational
Recruitment status: Completed
Enrolment: 6,000 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 24 Jun 2016 (actual)
Primary completion: 31 Oct 2022 (actual)
Study completion: 30 Mar 2023 (actual)
First posted: 21 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Evolocumab exposed	–	Other: No interventionPatients 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.)

Key inclusion criteria (1 listed)

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).

Key exclusion criteria (1 listed)

No exclusion criteria are applied.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No interventionNo intervention; observation of routine medical care	Other	Evolocumab exposed

Primary outcome

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.
Laboratory values for LDL-C
Time frame: 2 years
Laboratory values for HDL-C
Time frame: 2 years
Laboratory values for total cholesterol
Time frame: 2 years
Laboratory values for triglycerides
Time frame: 2 years
Laboratory values for Apolipoprotein (Apo) A1
Time frame: 2 years
This will be measured if feasible.
Laboratory values for Apolipoprotein (Apo) Apo B
Time frame: 2 years
This will be measured if feasible.
Laboratory values for Apolipoprotein (Apo) Apo E
Time frame: 2 years
This will be measured if feasible.
Laboratory values for lipoprotein(a)
Time frame: 2 years
This will be measured if feasible.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
Derived from this study: PubMed 39470058Yokote 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.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

138 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypercholesterolemia and Familial Hypercholesterolemia, run by Amgen at 138 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events and adverse drug reactions (time frame: 2 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02808403, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.