Lomitapide Observational Worldwide Evaluation Registry (LOWER)

Condition/Intervention: Hypercholesterolemia

Eligibility

Key Inclusion Criteria

  • Adult patients (at least 18 years old) who meet one of the following two criteria:
    • Initiating treatment with lomitapide at the time of registry enrollment or
    • Initiated treatment with lomitapide within 15 months prior to enrollment into the registry and after lomitapide commercial availability in the country
  • Patients who have the ability to understand the requirements of the study and provide written informed consent to comply with the study data collection procedures

Key Exclusion Criteria

  • Patients who are receiving lomitapide in clinical trials
  • Patients receiving an investigational agent, defined as any drug or biologic agent other than lomitapide that has not received Market Authorization in the country of participation

Full Study Name

LOWER: Lomitapide Observational Worldwide Evaluation Registry (IRB no. 36367)

Summary

The purpose of this data registry is to collect information about the long-term safety and effectiveness of a drug called Juxtapid (lomitapide) in clinical practice. Approved by the U.S. Food and Drug Administration, lomitapide is used for the treatment of patients with homozygous familial hypercholesterolaemia (HoFH). Patients with HoFH have very high levels of low-density lipoprotein cholesterol. In this observational study, study medication is not provided, and there are no study-required procedures or tests.


Principal Investigator

PK Shah, MD

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