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An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia

NCT00694109 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2016-09-09

Study results available
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Summary

To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in participants with familial hypercholesterolemia or severe hypercholesterolemia on lipid-lowering therapy who had completed either the 301012-CS5 (NCT00607373), 301012-CS7 (NCT00706849), 301012-CS17 (NCT00477594) or MIPO3500108 (NCT00794664) clinical drug trials.

Conditions

  • Lipid Metabolism, Inborn Errors
  • Hypercholesterolemia, Autosomal Dominant
  • Hyperlipidemias
  • Metabolic Diseases
  • Hyperlipoproteinemia Type II
  • Metabolism, Inborn Errors
  • Genetic Diseases, Inborn
  • Infant, Newborn, Diseases
  • Metabolic Disorder
  • Congenital Abnormalities
  • Hypercholesterolemia
  • Hyperlipoproteinemias
  • Dyslipidemias
  • Lipid Metabolism Disorders

Interventions

DRUG

Mipomersen Sodium

Subcutaneous injection as a single injection directly into the abdomen, thigh, or outer area of the upper arm.

Sponsors & Collaborators

  • Ionis Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Kastle Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States
  • Brazil
  • Canada
  • Singapore
  • South Africa
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00694109 on ClinicalTrials.gov