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Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia

NCT00477594 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-09-09

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of extended dosing of mipomersen in patients with familial hypercholesterolemia on lipid-lowering therapy who have completed either the 301012-CS8 (NCT00280995) or 301012-CS9 (NCT00281008) 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

200 mg/ml, in 1 ml solution for subcutaneous injection.

Sponsors & Collaborators

  • Ionis Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Kastle Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2011-03-31
Completion
2011-07-31

Countries

  • United States

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 NCT00477594 on ClinicalTrials.gov