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Global Lomitapide Pregnancy Exposure Registry

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ClinicalTrials.gov Identifier: NCT02399839
Recruitment Status : Enrolling by invitation
First Posted : March 26, 2015
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.

Brief Summary:
To evaluate the outcomes of pregnancy in women treated with lomitapide.

Condition or disease Intervention/treatment
Pregnancy Drug: lomitapide

Detailed Description:
To evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. The outcomes of primary interest are major congenital anomalies.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Global Lomitapide Pregnancy Exposure Registry
Study Start Date : October 2014
Estimated Primary Completion Date : March 2028
Estimated Study Completion Date : March 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Lomitapide


Intervention Details:
  • Drug: lomitapide
    As prescribed by Physician.
    Other Names:
    • Juxtapid
    • Lojuxta


Primary Outcome Measures :
  1. Pregnancy [ Time Frame: 2 Years ]
    To evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to first day of Last Menstrual Period (LMP) or during pregnancy.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant Females
Criteria

Inclusion Criteria:

  • Pregnant females exposed to lomitapide at any time within 30 days prior to first day of the LMP or during pregnancy.

Exclusion Criteria:

  • Patients who are unable or unwilling to provide written informed consent or assent are not eligible to participate in the PER.

Additional Information:

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Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02399839     History of Changes
Other Study ID Numbers: AEGR-733-027
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017