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

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00477594

Run by

Kastle Therapeutics, LLC

People needed

21

Starts

2007-05-01

Expected to finish

2011-07-01

Last updated by the study team

2016-09-09

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Satisfactory completion of dosing and Week 7 or Week 15 assessments (depending on the treatment and dose received) in their initial study (Protocol 301012-CS8 (NCT00280995) or 301012-CS9 (NCT00281008)).

You may not qualify if…

• Have a new condition or worsening of existing condition which in the opinion of the Investigator would make the patient unsuitable for enrollment, or could interfere with patient's participation in or completion of the study.

Where it is running

• Study site — Chicago, Illinois, United States
• Study site — Auburn, Maine, United States
• Study site — Biddeford, Maine, United States
• Study site — Scarborough, Maine, United States
• Study site — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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