NCT00281008

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

A Phase 2, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Efficacy, and Pharmacokinetics of ISIS 301012 as Add-on Therapy in Heterozygous Familial Hypercholesterolemia Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Kastle Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-07-01
• Completion: 2007-12-01
• First posted: 2006-01-24
• Last updated: 2016-08-03

Locations

8 sites across 2 countries: United States, Netherlands