Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy (ALINET)

January 21, 2026 updated by: Pasquale Perrone Filardi, Federico II University

Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy - The ALINET Registry

Evaluation of adherence, persistence and efficacy of treatment with alirocumab 300 mg in a real-life Italian population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pasquale Perrone Filardi
  • Phone Number: +390817462224
  • Email: fpperron@unina.it

Study Locations

  • Italy
    • Napoli
      • Napoli, Napoli, Italy, 80131
        • Recruiting
        • Federico II University of Naples, Department of Advanced Biomedical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes patients from Italy, who have received alirocumab 300mg as part of routine clinical management of their hyperlipidaemia at time of enrollment, based on national reimbursement criteria.

Description

Inclusion Criteria:

- Patients under alirocumab 300mg treatment.

Exclusion Criteria:

  • Age < 18 years o > 80 years;
  • Patients who refuse to participate and to sign informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with hyperlipidaemia under Alirocumab 300 mg treatment.
Subjects with hyperlipidaemia
Drug: Praluent (Alirocumab)
Alirocumab 300 mg injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of adherence of treatment with alirocumab 300mg in a real-life Italian population.
Time Frame: 6-12-24-36 months
Adherence will be assessed in terms of Medical Possession Ratio (MPR) which is defined as the ratio between the treatment units dispensed during the treatment period and the duration of the treatment period itself.
6-12-24-36 months
Description of persistence of treatment with alirocumab 300mg in a real-life Italian population.
Time Frame: 6-12-24-36 months
Persistence will be assessed in terms of therapeutic continuity from the start of treatment to enrollment.
6-12-24-36 months
Description of efficacy of treatment with alirocumab 300mg in a real-life Italian population.
Time Frame: 6-12-24-36 months
Efficacy of treatment will be evaluated as a change in the LDL (deltaLDL) value from the start of treatment (percentage and absolute value).
6-12-24-36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of safety of treatment with alirocumab 300mg in a real-life Italian population.
Time Frame: 6-12-24-36 months
Safety will be evaluated in terms of adverse reactions or intolerance to the drug.
6-12-24-36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prot. 28/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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