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A Safety and Efficacy Study of AEGR-733 to Treat Homozygous Familial Hypercholesterolemia (FH)

NCT00730236 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2018-03-20

Study results available
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Summary

The goal of this trial is to study the effects of AEGR-733 on LDL cholesterol, other lipids as well as measures of safety over the long-term.

Conditions

  • Homozygous Familial Hypercholesterolemia

Interventions

DRUG

AEGR-733

5-80 mg daily by mouth for 1.5 yrs

Sponsors & Collaborators

  • FDA Office of Orphan Products Development

    collaborator FED

  • Aegerion Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Sumeray, MD · Aegerion Pharmaceuticals, Inc.

  • Marina Cuchel, MD, PhD · Univerity of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-09-30
Completion
2011-10-31

Countries

  • United States
  • Canada
  • Italy
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00730236 on ClinicalTrials.gov