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NCT02135705 · ClinicalTrials.gov registry record
LOWER: Lomitapide Observational Worldwide Evaluation Registry
A clinical trial of Homozygous Familial Hypercholesterolemia, sponsored by Amryt Pharma.
- Recruiting
- Registry status
- 300
- Enrollment target
- 20
- Study locations
NCT02135705: Recruiting study of Homozygous Familial Hypercholesterolemia, sponsored by Amryt Pharma.
NCT02135705 is a study of Homozygous Familial Hypercholesterolemia that is actively recruiting participants, run by Amryt Pharma. The registered enrollment target is 300 participants, above the 202-participant average among 6 other Homozygous Familial Hypercholesterolemia trials with a reported enrollment target (49% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02135705, a study of Homozygous Familial Hypercholesterolemia, is actively recruiting participants, sponsored by Amryt Pharma.
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
to evaluate the occurrence of hepatic abnormalities
Conditions Studied
Interventions
- DRUG Lomitapide
Study Locations (20)
Arizona
- Northern Arizona Healthcare - Cottonwood
- One Medical - Gilbert
- Scottsdale Family Health - Phoenix
- Pima Heart - Tucson
Georgia
- Piedmont Heart Institute - Atlanta
- Atlanta Heart Specialists - Cumming
- Northside Hospital, Inc. - Cumming
Alabama
- Brookwood Baptist Medical Center - Birmingham
- Springhill Physician Practices - Mobile
Florida
- Preventative Cardiology, Inc. - Boca Raton
- Florida Lipid Institute - Winter Park
Indiana
- Community Health Network - Indianapolis
- St. Vincent Medical Group, Inc. - Indianapolis
Arkansas
- Arkansas Heart Center - Fort Smith
California
- Cedars-Sinai Medical Center - Los Angeles
Colorado
- University of Colorado Health - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2014-03-18 |
| Est. Completion | 2028-09-01 |
What NCT02135705 shows while recruiting
NCT02135705 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 202-participant average among 6 other Homozygous Familial Hypercholesterolemia trials with a reported enrollment target (49% higher).
The record links to 1 condition, with Homozygous Familial Hypercholesterolemia appearing as the primary indexed condition, and to 1 intervention - of which Lomitapide is the first listed.
NCT02135705 names 20 study sites across 12 states, led by Arizona, Georgia, Alabama.
Frequently Asked Questions
What is clinical trial NCT02135705 about?
NCT02135705 is a clinical study titled "LOWER: Lomitapide Observational Worldwide Evaluation Registry". 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.
What is the current status of trial NCT02135705?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2014-03-18. Estimated completion is 2028-09-01.
What conditions does trial NCT02135705 study?
This clinical trial studies the following conditions: Homozygous Familial Hypercholesterolemia.
What interventions are being tested in trial NCT02135705?
The interventions under investigation include: Lomitapide (DRUG).
Who is sponsoring clinical trial NCT02135705?
This trial is sponsored by Amryt Pharma, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02135705 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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