Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment
NCT ID: NCT02585895
Last Updated: 2022-11-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
39 participants
INTERVENTIONAL
2015-12-21
2017-01-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Open Label Study of Long Term Evaluation Against LDL-C Trial
NCT01439880
Evolocumab Versus LDL Apheresis in Patients With Hypercholesterolemia
NCT03429998
Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia
NCT02662569
Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities
NCT01588496
Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk
NCT01953328
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Evolocumab
Participants received 140 mg evolocumab every 2 weeks (Q2W) administered by subcutaneous injection for 6 weeks during the primary period of the study. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
Evolocumab
Administered by subcutaneous injection once every 2 weeks
Low Density Lipoprotein Cholesterol (LDL-C) Apheresis
Participants continued apheresis at the same schedule, every week (QW) or every two weeks (Q2W), as prior to study entry, for the first 6 weeks. Starting at week 6 (beginning of the post-primary period), participants received 140 mg evolocumab Q2W up to week 24.
Evolocumab
Administered by subcutaneous injection once every 2 weeks
Low-density Lipoprotein Cholesterol (LDL-C) Apheresis
Participants received apheresis for LDL-C according the their physician's prescription and local custom.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Evolocumab
Administered by subcutaneous injection once every 2 weeks
Low-density Lipoprotein Cholesterol (LDL-C) Apheresis
Participants received apheresis for LDL-C according the their physician's prescription and local custom.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject has been receiving regular apheresis for LDL-C lowering for at least 3 months immediately prior to lipid screening and has a treatment goal of LDL-C \< 100 mg/dL (2.6 mmol/L), and has been receiving LDL-C apheresis during the last ≥ 4 weeks prior to lipid screening at regular QW or Q2W schedule and with no changes in apheresis type
* Subject is receiving lipid-lowering pharmacological background therapy which includes a high-intensity statin dose (moderate-intensity statin dose with attestation that a higher dose is not appropriate for the subject) unless the subject has a history of statin intolerance
* Lipid-lowering therapy status (ie, any therapy for lowering lipids, including apheresis type and frequency) must be unchanged for ≥ 4 weeks prior to LDL-C screening
* Pre-apheresis LDL-C is ≥ 100 mg/dL (≥ 2.6 mmol/L) and ≤ 190 mg/dL (≤ 4.9 mmol/L) at screening
* Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) at screening.
Exclusion Criteria
* Missing any apheresis session is medically contraindicated or inappropriate
* Stopping apheresis would be inappropriate in the opinion of the investigator even if LDL-C is controlled to \< 100 mg/dL with other therapies
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization.
* Uncontrolled hypertension
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Boca Raton, Florida, United States
Research Site
Kansas City, Kansas, United States
Research Site
Grandville, Michigan, United States
Research Site
Portland, Oregon, United States
Research Site
Heidelberg, Victoria, Australia
Research Site
Hradec Králové, , Czechia
Research Site
Bron, , France
Research Site
Nantes, , France
Research Site
Berlin, , Germany
Research Site
Dresden, , Germany
Research Site
Düsseldorf, , Germany
Research Site
Flensburg, , Germany
Research Site
Pisa, , Italy
Research Site
Roma, , Italy
Research Site
Seville, Andalusia, Spain
Research Site
Harefield, , United Kingdom
Research Site
Penarth, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Baum SJ, Sampietro T, Datta D, Moriarty PM, Knusel B, Schneider J, Somaratne R, Kurtz C, Hohenstein B. Effect of evolocumab on lipoprotein apheresis requirement and lipid levels: Results of the randomized, controlled, open-label DE LAVAL study. J Clin Lipidol. 2019 Nov-Dec;13(6):901-909.e3. doi: 10.1016/j.jacl.2019.10.003. Epub 2019 Oct 11.
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-001343-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20140316
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.