LOWER: Lomitapide Observational Worldwide Evaluation Registry

Last updated: March 11, 2024
Sponsor: Amryt Pharma
Overall Status: Active - Recruiting

Phase

N/A

Condition

Familial Hypercholesterolemia

Hypercholesterolemia

Treatment

Lomitapide

Clinical Study ID

NCT02135705
AEGR-733-025
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients of all ages, including minors, who have initiated commercial treatment withlomitapide prior to or at time of registry enrolment.
  • Patients who have the ability to understand the requirements of the study and providewritten informed consent to comply with the study data collection procedures orpaediatric patients with the consent of a parent or legal guardian. Patients ≥7 years of age (or above the age determined by the IRB/EC and in accordance withthe local regulations and requirements) must also provide written informed assent forms.

Exclusion

Exclusion Criteria:

  • 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 agentother than lomitapide that has not received market authorization in the country ofparticipation, at time of lomitapide initiation and continuing to receive aninvestigational agent at time of registry enrolment. These patients may be enrolled ifreceiving lomitapide when the investigational agent is discontinued..

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Lomitapide
Phase:
Study Start date:
March 18, 2014
Estimated Completion Date:
September 01, 2028

Study Description

To evaluate the occurrence of adverse events of special interest, long term effectiveness of lomitapide, and to evaluate whether prescribers of lomitapide are following screening and monitoring recommendations as specified in product labeling.

Connect with a study center

  • Clinica de Salud de Chaco

    Reconquista, Chaco CPA H3500BJS
    Argentina

    Active - Recruiting

  • Nova Scotia Health Authority

    Halifax, Nova Scotia B3H2Y9
    Canada

    Active - Recruiting

  • Robarts Research Institute

    London, Ontario N6A5B7
    Canada

    Active - Recruiting

  • Ecogene-21

    Chicoutimi, Quebec G7H7K9
    Canada

    Active - Recruiting

  • McGill University

    Montréal, Quebec H4A3J1
    Canada

    Active - Recruiting

  • Centre Hospitalier Régional Universitaire de Lille

    Lille, Cedex 59037
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Lyon

    Bron, Lyon 69677
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire Strasbourg

    Strasbourg, 67000
    France

    Active - Recruiting

  • University General Hospital of Ioannina

    Ioánnina, 45500
    Greece

    Active - Recruiting

  • Metropolitan Hospital

    Piraeus, 18547
    Greece

    Active - Recruiting

  • Policlinico S. Orsola-Malpighi

    Bologna, BO 40138
    Italy

    Active - Recruiting

  • Azienda Ospedaliera G. Brotzu

    Cagliari, CA 09134
    Italy

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milano, MI 20162
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, PA 90127
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universita di Padova

    Padova, PD 35128
    Italy

    Active - Recruiting

  • Università degli Studi di Roma La Sapienza

    Roma, Rome 00161
    Italy

    Terminated

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, TO 10043
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universi consorziale policlinico di Bari

    Bari, 70120
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Specialistica Dei Colli

    Napoli, 80131
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Napoli, 80131
    Italy

    Active - Recruiting

  • CNR Regione Toscana - Fondazione Toscana Gabriele Monasterio

    Pisa, 56124
    Italy

    Active - Recruiting

  • Radboud Universiteit Medisch Centrum

    Nijmegen, Gelderland 6525 GA
    Netherlands

    Active - Recruiting

  • Erasmus Medisch Centrum

    Rotterdam, Zuid Holland 3015 GD
    Netherlands

    Active - Recruiting

  • Imperial College Healthcare - NHS Trust

    London, W12 0NN
    United Kingdom

    Active - Recruiting

  • Brookwood Baptist Medical Center

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Springhill Physician Practices

    Mobile, Alabama 36608
    United States

    Terminated

  • Northern Arizona Healthcare

    Cottonwood, Arizona 86326
    United States

    Active - Recruiting

  • One Medical

    Gilbert, Arizona 85296
    United States

    Site Not Available

  • Scottsdale Family Health

    Phoenix, Arizona 85018
    United States

    Active - Recruiting

  • Pima Heart

    Tucson, Arizona 85718
    United States

    Terminated

  • Arkansas Heart Center

    Fort Smith, Arkansas 72901
    United States

    Terminated

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Terminated

  • University of Colorado Health

    Aurora, Colorado 80045
    United States

    Terminated

  • Alfieri Cardiology

    Newark, Delaware 19713
    United States

    Terminated

  • Preventative Cardiology, Inc.

    Boca Raton, Florida 33434
    United States

    Active - Recruiting

  • Florida Lipid Institute

    Winter Park, Florida 32792-2223
    United States

    Terminated

  • Piedmont Heart Institute

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • Atlanta Heart Specialists

    Cumming, Georgia 30041
    United States

    Active - Recruiting

  • Northside Hospital, Inc.

    Cumming, Georgia 30041
    United States

    Active - Recruiting

  • Comprehensive Cardiovascular Care

    Gurnee, Illinois 60031
    United States

    Terminated

  • Community Health Network

    Indianapolis, Indiana 46250
    United States

    Terminated

  • St. Vincent Medical Group, Inc.

    Indianapolis, Indiana 46290
    United States

    Active - Recruiting

  • Henry County Medical Center

    New Castle, Kentucky 40050
    United States

    Terminated

  • Cardiovascular Institute of the South

    Houma, Louisiana 70360
    United States

    Active - Recruiting

  • Get Well Immediate Care

    Towson, Maryland 21204
    United States

    Terminated

  • University of Michigan Health System

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Complete Family Care Cholesterol Treatment Center

    Sterling Heights, Michigan 48314
    United States

    Terminated

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • HealthEast Care System

    Saint Paul, Minnesota 55102
    United States

    Terminated

  • Stern Cardiovascular Foundation

    Southaven, Mississippi 38671
    United States

    Active - Recruiting

  • Methodist Physicians Clinic

    Omaha, Nebraska 68114
    United States

    Active - Recruiting

  • Hackensack Meridian Health

    Edison, New Jersey 08817
    United States

    Site Not Available

  • Avinash C. Gupta, MD, PC

    Lakewood, New Jersey 08701
    United States

    Site Not Available

  • 201 Route 17 North

    Rutherford, New Jersey 07070
    United States

    Active - Recruiting

  • Valley Medical Group

    Wyckoff, New Jersey 07481
    United States

    Terminated

  • Murray Hill Medical Group

    New York, New York 10016
    United States

    Active - Recruiting

  • NY Heart Center

    Syracuse, New York 13210
    United States

    Terminated

  • Pediatric Cardiology Associates

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Cardiology Specialists Of Carolina

    Charlotte, North Carolina 28211
    United States

    Active - Recruiting

  • Cardiology Specialists of the Carolinas PA

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • The Heart Care Group, PC

    Allentown, Pennsylvania 18103
    United States

    Terminated

  • St. Luke's University Health Network - Pennsylvania

    Bethlehem, Pennsylvania 18015
    United States

    Terminated

  • Lehigh Valley Hospital And Health Network

    East Stroudsburg, Pennsylvania 18301
    United States

    Terminated

  • Cardiology Consultants of Philadelphia

    Philadelphia, Pennsylvania 19107
    United States

    Terminated

  • Thomas Jefferson University Health System

    Philadelphia, Pennsylvania 19148
    United States

    Active - Recruiting

  • Palmetto Health

    Columbia, South Carolina 29203
    United States

    Terminated

  • 317 Saint Francis Dr.

    Greenville, South Carolina 29601
    United States

    Active - Recruiting

  • Cardiovascular Specialists of Texas

    Austin, Texas 78758
    United States

    Terminated

  • Baylor Scott & White Health

    Dallas, Texas 75226
    United States

    Terminated

  • The University of Vermont Health Network

    Burlington, Vermont 05401-1473
    United States

    Active - Recruiting

  • West Virginia University Medicine

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

  • Ascension

    Milwaukee, Wisconsin 53211
    United States

    Terminated

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Terminated

  • Aspirus Research Institute

    Wausau, Wisconsin 54401
    United States

    Terminated

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