Homozygous Familial HypercholesterolemiaNCT02399852
Effects of Lomitapide on Carotid and Aortic Atherosclerosis
An observational study of Homozygous Familial Hypercholesterolemia, run by Aegerion Pharmaceuticals, Inc..
Trial summary
Study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Homozygous Familial Hypercholesterolemia
- What is being tested?
- Lomitapide
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Dec 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients enrolled in LOWER
Who may be able to join
- Adult patients (age ≥18 years) who are enrolled in LOWER
Who cannot join
- Patients with a prior history of carotid angioplasty, carotid stenting, or carotid atherectomy
- Patients with a contraindication to MRI examination (i.e., brain aneurysm, implanted neural stimulator, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body, or other implanted body)
- Patients who have undergone a coronary stenting procedure in the preceding three weeks prior to enrollment
- Patients prone to claustrophobia or known anxiety disorders that will interfere with the ability to acquire quality MRI scans
- Patients with an implanted insulin pump
- Patients with metal shrapnel or bullet wounds
- Patients with a body mass index (BMI) > 40 kg/m2 (since it may be difficult to position comfortably with the MRI scanner)
- Patients who work with metal lathes (unless an orbit x-ray performed prior to the enrollment MRI scan has been done to rule out metal fragments in the eye)
About this study
Official title: Effects of Lomitapide on Carotid and Aortic Atherosclerosis in Patients Treated With Lomitapide in Usual Care (CAPTURE)
Study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide.
Read the detailed description
This is a multi-center long-term open-label non-comparative study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide. Patients from countries in the EU, the US and Canada who are being treated with lomitapide and are enrolled in The Lomitapide Observational Worldwide Evaluation Registry (LOWER), will be invited by the LOWER enrolling physician to participate in this substudy.
- Conditions
- Homozygous Familial Hypercholesterolemia
- Being tested
- Lomitapide
- Medical subject headings
- Homozygous Familial Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LomitapideDrug
Also called Juxtapid, Lojuxta
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change from baseline in cartoid vessel wall area at the two-year evaluation
Measured: 2 years
Secondary outcomes (1)
The percent change from baseline to one and five years on therapy for carotid and aortic vessel wall area, and carotid and aortic vessel wall thickness.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Homozygous Familial HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Chang, MD, Principal investigator, Aegerion Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399852
- Sponsor's protocol ID
- AEGR-733-028
- Status last verified
- Mar 2015
- First submitted
- 23 Mar 2015
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lomitapide on Carotid and Aortic Atherosclerosis in Patients Treated With Lomitapide in Usual Care (CAPTURE)
- ClinicalTrials.gov ID
- NCT02399852
- Acronym / sponsor ID
- AEGR-733-028
- Conditions
- Homozygous Familial Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide.
Detailed description
This is a multi-center long-term open-label non-comparative study to assess changes in carotid and aortic atherosclerosis in patients being treated with lomitapide. Patients from countries in the EU, the US and Canada who are being treated with lomitapide and are enrolled in The Lomitapide Observational Worldwide Evaluation Registry (LOWER), will be invited by the LOWER enrolling physician to participate in this substudy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled in LOWER
Key inclusion criteria (1 listed)
- Adult patients (age ≥18 years) who are enrolled in LOWER
Key exclusion criteria (8 listed)
- Patients with a prior history of carotid angioplasty, carotid stenting, or carotid atherectomy
- Patients with a contraindication to MRI examination (i.e., brain aneurysm, implanted neural stimulator, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body, or other implanted body)
- Patients who have undergone a coronary stenting procedure in the preceding three weeks prior to enrollment
- Patients prone to claustrophobia or known anxiety disorders that will interfere with the ability to acquire quality MRI scans
- Patients with an implanted insulin pump
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LomitapideAlso: Juxtapid, Lojuxta | Drug | – |
Primary outcome
The percent change from baseline in cartoid vessel wall area at the two-year evaluation
Time frame: 2 years
1 secondary outcome
The percent change from baseline to one and five years on therapy for carotid and aortic vessel wall area, and carotid and aortic vessel wall thickness.
Time frame: 5 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qing Chang, MD principal investigator
Aegerion Pharmaceuticals, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Homozygous Familial Hypercholesterolemia, run by Aegerion Pharmaceuticals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent change from baseline in cartoid vessel wall area at the two-year evaluation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2017.