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

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ClinicalTrials.gov Identifier: NCT02808403
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

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
Hypercholesterolemia Familial Hypercholesterolemia Other: No intervention

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
Estimated 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 : June 24, 2016
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

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




Primary Outcome Measures :
  1. 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. Laboratory values for LDL-C [ Time Frame: 2 years ]
  3. Laboratory values for HDL-C [ Time Frame: 2 years ]
  4. Laboratory values for total cholesterol [ Time Frame: 2 years ]
  5. Laboratory values for triglycerides [ Time Frame: 2 years ]
  6. Laboratory values for Apolipoprotein (Apo) A1 [ Time Frame: 2 years ]
    This will be measured if feasible.

  7. Laboratory values for Apolipoprotein (Apo) Apo B [ Time Frame: 2 years ]
    This will be measured if feasible.

  8. Laboratory values for Apolipoprotein (Apo) Apo E [ Time Frame: 2 years ]
    This will be measured if feasible.

  9. Laboratory values for lipoprotein(a) [ Time Frame: 2 years ]
    This will be measured if feasible.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808403


Contacts
Contact: Amgen Call Center 866-572-6436

  Show 139 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02808403     History of Changes
Other Study ID Numbers: 20140409
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://www.amgen.com/datasharing

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs