LOWER: Lomitapide Observational Worldwide Evaluation Registry
NCT ID: NCT02135705
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
300 participants
OBSERVATIONAL
2014-03-18
2028-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long Term, Follow-on Study of Lomitapide in Patients With Homozygous Familial Hypercholesterolemia
NCT00943306
Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy
NCT02173158
Efficacy and Safety of Lomitapide in Paediatric Patients With Homozygous Familial Hypercholesterolaemia (HoFH)
NCT04681170
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
NCT06832371
Evaluate the Efficacy and Safety of Lomitapide in Pediatric Patients With Homozygous Familial Hypercholesterolemia on Stable Lipid-lowering Therapy
NCT02765841
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lomitapide
Lomitapide as prescribed by Physician.
Lomitapide
As prescribed by Physician.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lomitapide
As prescribed by Physician.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 ≥7 years of age (or above the age determined by the IRB/EC and in accordance with the local regulations and requirements) must also provide written informed assent forms.
Exclusion Criteria
* 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..
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amryt Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janet Boylan
Role: STUDY_DIRECTOR
Amryt Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Brookwood Baptist Medical Center
Birmingham, Alabama, United States
Springhill Physician Practices
Mobile, Alabama, United States
Northern Arizona Healthcare
Cottonwood, Arizona, United States
One Medical
Gilbert, Arizona, United States
Scottsdale Family Health
Phoenix, Arizona, United States
Pima Heart
Tucson, Arizona, United States
Arkansas Heart Center
Fort Smith, Arkansas, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of Colorado Health
Aurora, Colorado, United States
Alfieri Cardiology
Newark, Delaware, United States
Preventative Cardiology, Inc.
Boca Raton, Florida, United States
Florida Lipid Institute
Winter Park, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Atlanta Heart Specialists
Cumming, Georgia, United States
Northside Hospital, Inc.
Cumming, Georgia, United States
Comprehensive Cardiovascular Care
Gurnee, Illinois, United States
Community Health Network
Indianapolis, Indiana, United States
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, United States
Henry County Medical Center
New Castle, Kentucky, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Get Well Immediate Care
Towson, Maryland, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Complete Family Care Cholesterol Treatment Center
Sterling Heights, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
HealthEast Care System
Saint Paul, Minnesota, United States
Stern Cardiovascular Foundation
Southaven, Mississippi, United States
Methodist Physicians Clinic
Omaha, Nebraska, United States
Hackensack Meridian Health
Edison, New Jersey, United States
Avinash C. Gupta, MD, PC
Lakewood, New Jersey, United States
201 Route 17 North
Rutherford, New Jersey, United States
Valley Medical Group
Wyckoff, New Jersey, United States
Murray Hill Medical Group
New York, New York, United States
NY Heart Center
Syracuse, New York, United States
Pediatric Cardiology Associates
Syracuse, New York, United States
Cardiology Specialists of the Carolinas PA
Charlotte, North Carolina, United States
Cardiology Specialists Of Carolina
Charlotte, North Carolina, United States
The Heart Care Group, PC
Allentown, Pennsylvania, United States
St. Luke's University Health Network - Pennsylvania
Bethlehem, Pennsylvania, United States
Lehigh Valley Hospital And Health Network
East Stroudsburg, Pennsylvania, United States
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Health System
Philadelphia, Pennsylvania, United States
Palmetto Health
Columbia, South Carolina, United States
317 Saint Francis Dr.
Greenville, South Carolina, United States
Cardiovascular Specialists of Texas
Austin, Texas, United States
Baylor Scott & White Health
Dallas, Texas, United States
The University of Vermont Health Network
Burlington, Vermont, United States
West Virginia University Medicine
Morgantown, West Virginia, United States
Ascension
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Aspirus Research Institute
Wausau, Wisconsin, United States
Clinica de Salud de Chaco
Reconquista, Chaco CPA, Argentina
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Robarts Research Institute
London, Ontario, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
McGill University
Montreal, Quebec, Canada
Centre Hospitalier Régional Universitaire de Lille
Lille, Cedex, France
Centre Hospitalier Universitaire Lyon
Bron, Lyon, France
Centre Hospitalier Universitaire Strasbourg
Strasbourg, , France
University General Hospital of Ioannina
Ioannina, , Greece
Metropolitan Hospital
Piraeus, , Greece
Policlinico S. Orsola-Malpighi
Bologna, BO, Italy
Azienda Ospedaliera G. Brotzu
Cagliari, CA, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, PA, Italy
Azienda Ospedaliera Universita di Padova
Padua, PD, Italy
Università degli Studi di Roma La Sapienza
Roma, RM, Italy
Università degli Studi di Roma La Sapienza
Roma, Rome, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, TO, Italy
Azienda Ospedaliero Universi consorziale policlinico di Bari
Bari, , Italy
Azienda Ospedaliera Specialistica Dei Colli
Napoli, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
CNR Regione Toscana - Fondazione Toscana Gabriele Monasterio
Pisa, , Italy
Radboud Universiteit Medisch Centrum
Nijmegen, Gelderland, Netherlands
Erasmus Medisch Centrum
Rotterdam, South Holland, Netherlands
Imperial College Healthcare - NHS Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
John Henry, MD
Role: primary
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Larrey D, D'Erasmo L, O'Brien S, Arca M; Italian Working Group on Lomitapide. Long-term hepatic safety of lomitapide in homozygous familial hypercholesterolaemia. Liver Int. 2023 Feb;43(2):413-423. doi: 10.1111/liv.15497. Epub 2022 Dec 30.
Giammanco A, Cefalu AB, Noto D, Averna MR. Therapeutic Options for Homozygous Familial Hypercholesterolemia: The Role of Lomitapide. Curr Med Chem. 2020;27(23):3773-3783. doi: 10.2174/0929867326666190121120735.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AEGR-733-025
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.