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LOWER: Lomitapide Observational Worldwide Evaluation Registry (LOWER)

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ClinicalTrials.gov Identifier: NCT02135705
Recruitment Status : Enrolling by invitation
First Posted : May 12, 2014
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.

Brief 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.

Condition or disease Intervention/treatment
Homozygous Familial Hypercholesterolemia Drug: 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: LOWER: Lomitapide Observational Worldwide Evaluation Registry
Study Start Date : March 2014
Estimated Primary Completion Date : March 2028
Estimated Study Completion Date : September 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Lomitapide

Group/Cohort Intervention/treatment
Lomitapide
Lomitapide as prescribed by Physician.
Drug: Lomitapide
As prescribed by Physician.
Other Names:
  • Juxtapid
  • Lojuxta




Primary Outcome Measures :
  1. Hepatic Abnormalities [ Time Frame: patients will be followed for 10 years ]
    to evaluate the occurrence of hepatic abnormalities


Secondary Outcome Measures :
  1. Gastrointestinal (GI) Events [ Time Frame: patients will be followed for 10 years ]
    to evaluate the occurrence of GI events

  2. Tumors [ Time Frame: patients will be followed for 10 years ]
    to evaluate any occurrence of tumors (small bowel, hepatic, colorectal or pancreatic)

  3. Events associated with coagulopathy [ Time Frame: patients will be followed for 10 years ]
    to evaluate the occurrence of events associated with coagulopathy (abnormal bleeding, cerebral haemorrhage or GI bleeding)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients treated with lomitapide who agree to participate in the study.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135705


Locations
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United States, Michigan
Complete Family Care
Sterling Heights, Michigan, United States, 48314
Sponsors and Collaborators
Aegerion Pharmaceuticals, Inc.

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02135705     History of Changes
Other Study ID Numbers: AEGR-733-025
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias