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NCT Number: NCT07375225

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

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

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Key information

Conditions

Hypercholesterolaemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Federico II University of Naples, Department of Advanced Biomedical Sciences

Naples, Napoli, 80131, Italy

Location status: Recruiting

Location contact

Pasquale Perrone Filardi

CONTACT

[email protected]

+390817462224

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Praluent (Alirocumab)

Drug

Alirocumab 300 mg injection

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pasquale Perrone Filardi

CONTACT

[email protected]

+390817462224

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: ALINET

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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