RECRUITING

LOWER: Lomitapide Observational Worldwide Evaluation Registry

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Conditions

Homozygous Familial Hypercholesterolemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

LOWER: Lomitapide Observational Worldwide Evaluation Registry

Quick Facts

Study Start:2014-03-18
Study Completion:2028-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02135705

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients of all ages, including minors, who have initiated commercial treatment with lomitapide prior to or at time of registry enrolment.
  2. * 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.
  1. * Patients who are receiving lomitapide in clinical trials or through compassionate use, where patients are followed under a separate protocol.
  2. * 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..

Contacts and Locations

Study Contact

Janet Boylan
CONTACT
1 855 303 2347
Janet.Boylan@AmrytPharma.com

Principal Investigator

Janet Boylan
STUDY_DIRECTOR
Amryt Pharmaceuticals

Study Locations (Sites)

Brookwood Baptist Medical Center
Birmingham, Alabama, 35209
United States
Springhill Physician Practices
Mobile, Alabama, 36608
United States
Northern Arizona Healthcare
Cottonwood, Arizona, 86326
United States
One Medical
Gilbert, Arizona, 85296
United States
Scottsdale Family Health
Phoenix, Arizona, 85018
United States
Pima Heart
Tucson, Arizona, 85718
United States
Arkansas Heart Center
Fort Smith, Arkansas, 72901
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
University of Colorado Health
Aurora, Colorado, 80045
United States
Alfieri Cardiology
Newark, Delaware, 19713
United States
Preventative Cardiology, Inc.
Boca Raton, Florida, 33434
United States
Florida Lipid Institute
Winter Park, Florida, 32792-2223
United States
Piedmont Heart Institute
Atlanta, Georgia, 30309
United States
Atlanta Heart Specialists
Cumming, Georgia, 30041
United States
Northside Hospital, Inc.
Cumming, Georgia, 30041
United States
Comprehensive Cardiovascular Care
Gurnee, Illinois, 60031
United States
Community Health Network
Indianapolis, Indiana, 46250
United States
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, 46290
United States
Henry County Medical Center
New Castle, Kentucky, 40050
United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360
United States
Get Well Immediate Care
Towson, Maryland, 21204
United States
University of Michigan Health System
Ann Arbor, Michigan, 48109
United States
Complete Family Care Cholesterol Treatment Center
Sterling Heights, Michigan, 48314
United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
United States
HealthEast Care System
Saint Paul, Minnesota, 55102
United States
Stern Cardiovascular Foundation
Southaven, Mississippi, 38671
United States
Methodist Physicians Clinic
Omaha, Nebraska, 68114
United States
Hackensack Meridian Health
Edison, New Jersey, 08817
United States
Avinash C. Gupta, MD, PC
Lakewood, New Jersey, 08701
United States
201 Route 17 North
Rutherford, New Jersey, 07070
United States
Valley Medical Group
Wyckoff, New Jersey, 07481
United States
Murray Hill Medical Group
New York, New York, 10016
United States
NY Heart Center
Syracuse, New York, 13210
United States
Pediatric Cardiology Associates
Syracuse, New York, 13210
United States
Cardiology Specialists of the Carolinas PA
Charlotte, North Carolina, 28204
United States
Cardiology Specialists Of Carolina
Charlotte, North Carolina, 28211
United States
The Heart Care Group, PC
Allentown, Pennsylvania, 18103
United States
St. Luke's University Health Network - Pennsylvania
Bethlehem, Pennsylvania, 18015
United States
Lehigh Valley Hospital And Health Network
East Stroudsburg, Pennsylvania, 18301
United States
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania, 19107
United States
Thomas Jefferson University Health System
Philadelphia, Pennsylvania, 19148
United States
Palmetto Health
Columbia, South Carolina, 29203
United States
317 Saint Francis Dr.
Greenville, South Carolina, 29601
United States
Cardiovascular Specialists of Texas
Austin, Texas, 78758
United States
Baylor Scott & White Health
Dallas, Texas, 75226
United States
The University of Vermont Health Network
Burlington, Vermont, 05401-1473
United States
West Virginia University Medicine
Morgantown, West Virginia, 26506
United States
Ascension
Milwaukee, Wisconsin, 53211
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Aspirus Research Institute
Wausau, Wisconsin, 54401
United States

Collaborators and Investigators

Sponsor: Amryt Pharma

  • Janet Boylan, STUDY_DIRECTOR, Amryt Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-03-18
Study Completion Date2028-09-01

Study Record Updates

Study Start Date2014-03-18
Study Completion Date2028-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Homozygous Familial Hypercholesterolemia