LOWER: Lomitapide Observational Worldwide Evaluation Registry
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/17/2017 |
| Start Date: | March 2014 |
| End Date: | September 2028 |
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.
cohort study (exposure registry), designed to evaluate the long term safety and effectiveness
of lomitapide.
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.
lomitapide, and to evaluate whether prescribers of lomitapide are following screening and
monitoring recommendations as specified in product labeling.
Inclusion Criteria:
- Adult patients (age ≥18 years) who meet one of the following two criteria:
Initiating treatment with lomitapide at the time of registry enrolment, or initiated
treatment with lomitapide within 15 months prior to enrolment into the registry and after
lomitapide commercial availability in the country.
- Patients who have the ability to understand the requirements of the study and provide
written informed consent to comply with the study data collection procedures.
Exclusion Criteria:
- Patients who are receiving lomitapide in clinical trials
- Patients receiving an investigational agent, defined as any drug or biologic agent
other than lomitapide that has not received MA in the country of participation.
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