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Lomitapide for Hypercholesterolemia (LOWER Trial)

N/A
Recruiting
Research Sponsored by Amryt Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be followed for 10 years
Awards & highlights

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.

Eligible Conditions
  • Hypercholesterolemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be followed for 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be followed for 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hepatic Abnormalities
Secondary study objectives
Death, including cause of death
Blood Coagulation Disorders
Gastrointestinal (GI) Events
+5 more

Side effects data

From 2004 Phase 2 trial • 6 Patients • NCT01556906
83%
Diarrhoea
67%
Oropharyngeal pain
67%
Lung disorder
50%
Headache
50%
Aspartate aminotransferase increased
50%
Alinine aminotransferase increased
33%
Fatigue
33%
Nausea
33%
Cough
33%
International normalized ratio increased
33%
Abdominal pain upper
33%
Arthralgia
33%
Vomiting
33%
Nasal congestion
17%
Dizziness
17%
Myalgia
17%
Constipation
17%
Haemoglobinuria
17%
Asthenia
17%
Eye disorders
17%
Hyperhidrosis
17%
Chest pain
17%
Sneezing
17%
Acne
17%
Pain in extremity
17%
Rash
17%
Decreased appetite
17%
Contusion
17%
Scratch
17%
Neck pain
17%
Rhinitis
17%
Prothrombin time prolonged
17%
Breast mass
17%
Ovarian cyst
17%
Dyspnoea
17%
Dyspepsia
17%
Hot flush
17%
Xanthoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lomitapide Escalated

Trial Design

1Treatment groups
Experimental Treatment
Group I: LomitapideExperimental Treatment1 Intervention
Lomitapide as prescribed by Physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lomitapide
FDA approved

Find a Location

Who is running the clinical trial?

Amryt PharmaLead Sponsor
7 Previous Clinical Trials
727 Total Patients Enrolled
1 Trials studying Hypercholesterolemia
46 Patients Enrolled for Hypercholesterolemia
Sallyann O'BrienStudy DirectorAmryt Pharmaceuticals
1 Previous Clinical Trials
5 Total Patients Enrolled
Janet BoylanStudy DirectorAmryt Pharmaceuticals
1 Previous Clinical Trials
10 Total Patients Enrolled
~74 spots leftby Mar 2028
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