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Study of ISIS 301012 (Mipomersen) in Heterozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy

NCT00281008 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2016-08-03

No results posted yet for this study

Summary

The aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012 (mipomersen) as add-on therapy in subjects with Heterozygous Familial Hypercholesterolemia

Conditions

  • Hypercholesterolemia, Familial

Interventions

DRUG

ISIS 301012 or Placebo

50 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36

DRUG

ISIS 301012 or Placebo

100 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36

DRUG

ISIS 301012 or Placebo

200 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, and 36

DRUG

ISIS 301012 or Placebo

300 mg subcutaneous injections on days 1, 4, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85

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
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2007-07-31
Completion
2007-12-31

Countries

  • United States
  • Netherlands

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 NCT00281008 on ClinicalTrials.gov