CompletedPhase 3

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

United States144 participantsStarted 2008-04

Plain-language summary

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.

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Satisfactory completion of dosing in their initial study (Protocol 301012-CS5 \[NCT00607373\], 301012-CS7 \[NCT00706849\], 301012-CS17 \[NCT00477594\], or MIPO3500108 \[NCT00794664\]) Exclusion Criteria: * 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

What they're measuring

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)

Timeframe: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)

Percent Change From Baseline in Apolipoprotein B (Apo B)

Timeframe: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)

Percent Change From Baseline in Total Cholesterol

Timeframe: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)

Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)

Timeframe: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)

Trial details

NCT IDNCT00694109

SponsorKastle Therapeutics, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-09

Results submitted2015-09-11

View on ClinicalTrials.gov More Lipid Metabolism, Inborn Errors trials

Plain-language summary

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)

Timeframe: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)

Percent Change From Baseline in Apolipoprotein B (Apo B)

Timeframe: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)

Percent Change From Baseline in Total Cholesterol

Timeframe: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)

Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C)

Timeframe: Baseline up to Week 234; 24 weeks post treatment (up to 4.5 years)