Trial · NCT02135705
LOWER: Lomitapide Observational Worldwide Evaluation Registry
NCT02135705, Completed, Amryt Pharma
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. LOWER: Lomitapide Observational Worldwide Evaluation Registry. Trials, record NCT02135705. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02135705
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LOWER: Lomitapide Observational Worldwide Evaluation Registry
- NCT number
- NCT02135705
- Status
- Completed
- Enrollment
- 260 participants, actual
- Lead sponsor
- Amryt Pharma
- Conditions
- Homozygous Familial Hypercholesterolemia
- Interventions
- Lomitapide
- First posted
- 2014-05-12
- Last updated
- 2026-05-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hepatic Abnormalities | patients will be followed for 10 years | to evaluate the occurrence of hepatic abnormalities |
| Secondary | Gastrointestinal (GI) Events | patients will be followed for 10 years | to evaluate the occurrence of GI events |
| Secondary | Tumors | patients will be followed for 10 years | to evaluate any occurrence of tumors (small bowel, hepatic, colorectal or pancreatic) |
| Secondary | Events associated with coagulopathy | patients will be followed for 10 years | to evaluate the occurrence of events associated with coagulopathy (abnormal bleeding, cerebral haemorrhage or GI bleeding) |
| Secondary | Major Adverse Cardiovascular Events (MACE) events | patients will be followed for 10 years | to evaluate the occurrence of MACE events |
| Secondary | Death, including cause of death | patients will be followed for 10 years | to evaluate the occurrence and cause of death |
| Secondary | Pregnancy | patients will be followed for 10 years | to evaluate the occurrence and outcomes of pregnancy in females of reproductive potential treated with lomitapide. Patients who become pregnant will be offered enrolment into a separate Pregnancy Exposure Registry (PER). |
| Secondary | Serum lipid levels | patients will be followed for 10 years | to evaluate the long-term effectiveness of lomitapide in maintaining control of serum lipid levels in a clinical practice setting. |
| Secondary | Prescriber behavior | patients will be followed for 10 years | to evaluate whether prescribers of lomitapide enrolled at registry sites are following the screening and monitoring recommendations as specified in the PI and the prescriber educational materials aimed at risk minimization. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02135705
GET https://conductscience.org/api/trials/v1/NCT02135705/registered