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.

Updated on 25 Mar 2025. Study ID: NCT05129241

This study investigates the effectiveness of an investigational medication for lowering cholesterol in people with high cholesterol levels. High cholesterol, also known as hypercholesterolemia, is a condition where there are high levels of fat in the blood, which can increase the risk of heart disease. The study will measure how well the investigational medication works to lower cholesterol levels over a period of approximately 12 weeks.

Participants in the study will use an auto-injector to receive the investigational medication. The study will also assess how satisfied participants are with the treatment and how well they follow the treatment plan. Additionally, the study will monitor the safety and tolerability of the medication, which means they will check for any side effects or issues during the study.

  • Who can participate: Adults with high cholesterol levels who have not had adequate results from other treatments may participate. Participants must not have used certain cholesterol-lowering medications recently and should not be involved in another clinical study.
  • Study details: Participants will use an auto-injector for the investigational medication. The study will monitor their cholesterol levels and gather feedback on treatment satisfaction and adherence.
  • Study timelines: The study will last approximately 12 weeks.