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

NCT07375225 | Recruiting DMC FDA Drug

• 1 other identifier: Prot. 28/2024
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypercholesterolaemia

Outcome Measures

Primary Outcomes (3)

• Description of adherence of treatment with alirocumab 300mg in a real-life Italian population.

  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.

  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.

  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 Outcomes (1)

• Description of safety of treatment with alirocumab 300mg in a real-life Italian population.

  6-12-24-36 months

Study Arms (1)

Subjects with hyperlipidaemia under Alirocumab 300 mg treatment.

Subjects with hyperlipidaemia

Drug: Praluent (Alirocumab)

Interventions

Praluent (Alirocumab) DRUG

Alirocumab 300 mg injection

Subjects with hyperlipidaemia under Alirocumab 300 mg treatment.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Patients under alirocumab 300mg treatment.

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University of Naples, Department of Advanced Biomedical Sciences

Naples, Napoli, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

alirocumab

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Pasquale Perrone Filardi

CONTACT

+390817462224; fpperron@unina.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

IT (1)