LOWER: Lomitapide Observational Worldwide Evaluation Registry

Description

This global product exposure registry is a multicentre, long-term, prospective, observational cohort study (exposure registry), designed to evaluate the long term safety and effectiveness of lomitapide.

Conditions

Homozygous Familial Hypercholesterolemia

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Study Overview

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Study Details

Study overview

This global product exposure registry is a multicentre, long-term, prospective, observational cohort study (exposure registry), designed to evaluate the long term safety and effectiveness of lomitapide.

LOWER: Lomitapide Observational Worldwide Evaluation Registry

LOWER: Lomitapide Observational Worldwide Evaluation Registry

Condition
Homozygous Familial Hypercholesterolemia
Intervention / Treatment

-

Contacts and Locations

Birmingham

Brookwood Baptist Medical Center, Birmingham, Alabama, United States, 35209

Mobile

Springhill Physician Practices, Mobile, Alabama, United States, 36608

Cottonwood

Northern Arizona Healthcare, Cottonwood, Arizona, United States, 86326

Gilbert

One Medical, Gilbert, Arizona, United States, 85296

Phoenix

Scottsdale Family Health, Phoenix, Arizona, United States, 85018

Tucson

Pima Heart, Tucson, Arizona, United States, 85718

Fort Smith

Arkansas Heart Center, Fort Smith, Arkansas, United States, 72901

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Aurora

University of Colorado Health, Aurora, Colorado, United States, 80045

Newark

Alfieri Cardiology, Newark, Delaware, United States, 19713

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients of all ages, including minors, who have initiated commercial treatment with lomitapide prior to or at time of registry enrolment.
  • * 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 or paediatric patients with the consent of a parent or legal guardian.
  • * Patients who are receiving lomitapide in clinical trials or through compassionate use, where patients are followed under a separate protocol.
  • * 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, at time of lomitapide initiation and continuing to receive an investigational agent at time of registry enrolment. These patients may be enrolled if receiving lomitapide when the investigational agent is discontinued..

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amryt Pharma,

Janet Boylan, STUDY_DIRECTOR, Amryt Pharmaceuticals

Study Record Dates

2028-09-01