RECRUITINGOBSERVATIONAL
LOWER: Lomitapide Observational Worldwide Evaluation Registry
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form 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.
Who Should NOT Join This Trial:
- 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..
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion 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 ≥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 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..
Treatments Being Tested
DRUG
Lomitapide
As prescribed by Physician.
Locations (20)
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