This study is currently not recruiting participants.

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

Study on Monthly Investigational Medication for High Cholesterol

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 primary hypercholesterolemia and mixed dyslipidemia. The purpose is to evaluate the monthly administration of an investigational medication using a specific auto-injector.

The study will assess the effectiveness of the medication in lowering lipid levels. It will also evaluate treatment satisfaction, adherence, and safety.

  • Who can participate: Adults with primary hypercholesterolemia or mixed dyslipidemia who have inadequate reduction of LDL-C despite maximum therapy may participate. Participants must not be under 18 years or have existing pregnancy, cancer, or dementia.
  • Study details: Participants will use an investigational auto-injector once a month. The study will evaluate how well the medication works and participant satisfaction.
  • Study timelines: The study will last 12 weeks.
Updated on 25 Mar 2025. Study ID: NCT05129241