Trials / Recruiting
RecruitingNCT02135705
LOWER: Lomitapide Observational Worldwide Evaluation Registry
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Amryt Pharma · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
To evaluate the occurrence of adverse events of special interest, long term effectiveness of lomitapide, and to evaluate whether prescribers of lomitapide are following screening and monitoring recommendations as specified in product labeling.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lomitapide | As prescribed by Physician. |
Timeline
- Start date
- 2014-03-18
- Primary completion
- 2028-03-01
- Completion
- 2028-09-01
- First posted
- 2014-05-12
- Last updated
- 2024-03-12
Locations
75 sites across 8 countries: United States, Argentina, Canada, France, Greece, Italy, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT02135705. Inclusion in this directory is not an endorsement.