Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the … (NCT05129241) | Clinical Trial Compass
CompletedNot Applicable
Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector
Germany163 participantsStarted 2021-11-18
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 clinic…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Absolute change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)
Timeframe: from baseline to week 12
2
Percent change from baseline to week 12 in low-density lipoprotein cholesterol (LDL-C)
Timeframe: from baseline to week 12
3
Treatment acceptance assessed using the Injection Treatment Acceptance Questionnaire (ITAQ)