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

Completed · Phase 3

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

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.

Key facts

Study ID

NCT00694109

Run by

Kastle Therapeutics, LLC

People needed

144

Starts

2008-04-01

Expected to finish

2014-09-01

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 in their initial study (Protocol 301012-CS5 [NCT00607373], 301012-CS7 [NCT00706849], 301012-CS17 [NCT00477594], or MIPO3500108 [NCT00794664])

You may not qualify if…

• Had any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study

Where it is running

• Study site — Mission Viejo, California, United States
• Study site — Newport Beach, California, United States
• Study site — Bridgeport, Connecticut, United States
• Study site — Melbourne, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Kansas City, Kansas, United States
• Study site — Biddeford, Maine, United States
• Study site — Boston, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — Concord, New Hampshire, United States
• Study site — New York, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Franklin, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — São Paulo, São Paulo, Brazil
• Study site — Winnipeg, Manitoba, Canada
• Study site — London, Ontario, Canada
• Study site — Chicoutimi, Quebec, Canada
• Study site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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