Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector

Study on the Effectiveness of an Investigational Medication for Cholesterol Management

Not Recruiting
18 years or above
All
Phase N/A
163 participants needed

Study Overview

Primary objectives:

  • To assess the effectiveness of the PRALUENT® 2 ml SYDNEY auto-injector as measured by the lipid-lowering effect of alirocumab after approx. 12 weeks treatment
  • To assess the treatment satisfaction, as well as patient adherence and persistence after approximately 12 weeks of treatment with the PRALUENT® 2 ml SYDNEY auto-injector

Secondary objective:

Safety and tolerability

Study Details

Study duration per participant is approximately 12 weeks

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Primary Hypercholesterolaemia and Mixed Dyslipidaemia, Atherosclerotic Cardiovascular Disease
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • Primary hypercholesterolaemia (heterozygous familial or non-familial) or mixed dyslipidaemia AND confirmed vascular disease() AND other regular risk factors(*), OR confirmed familial heterozygous hypercholesterolaemia
  • Documented maximum dietary and drug lipid-lowering therapy within the last 12 months
  • Inadequate reduction of low-density lipoprotein cholesterol (LDL-C) despite maximum possible dietary and lipid-lowering therapy
  • The decision of the treating physician to use the PRALUENT® 2 ml SYDNEY auto-injector regardless of study enrolment
  • No previous therapy with a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor OR prior treatment with a PCSK9 inhibitor every 2 weeks (Q2W) or monthly (Q4W)
  • Signed Informed Consent Form

(*) Coronary heart disease (CHD), cerebrovascular manifestation, peripheral arterial occlusive disease (PAOD)

(**) For cardiovascular events (e.g. diabetes mellitus, renal function glomerular filtration rate (GFR) < 60 ml/min)

Exclusion Criteria:

  • Planned or existing pregnancy, cancer, drug or alcohol abuse, dementia, or general inability to understand the content of the observational study
  • Existing treatment by lipid apheresis
  • Age < 18 years
  • Contraindications to treatment with alirocumab (PRALUENT®) according to the SmPC
  • Current participation in a clinical study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

This study investigates the use of an investigational medication delivered through a 2 ml auto-injector device for individuals with high cholesterol levels. The purpose is to evaluate the medication's ability to lower lipid levels in participants who have primary hypercholesterolemia or mixed dyslipidemia. These conditions can increase the risk of heart disease and other vascular problems.

Participants in this study will use the investigational medication with the auto-injector device for a period of approximately 12 weeks. The study will monitor the effectiveness of the medication in lowering cholesterol levels and assess participants' satisfaction with the treatment. Safety and tolerability of the medication will also be evaluated.

  • Who can participate: Adults aged 18 and older with primary hypercholesterolemia or mixed dyslipidemia, and confirmed vascular disease, are eligible. Participants must have inadequate reduction of LDL cholesterol despite maximum dietary and drug therapy, and must not have prior therapy with a PCSK9 inhibitor.
  • Study details: Participants will use an investigational medication with an auto-injector to manage cholesterol levels. The study will assess lipid-lowering effects and treatment satisfaction. No placebo is involved.
  • Study timelines: The study will last approximately 12 weeks.
Updated on 25 Mar 2025. Study ID: NCT05129241