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
Public ClinicalTrials.gov record NCT00694109. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00694109
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 144 participants
Conditions and interventions
Conditions
- 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
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2008 (Type not available)
- Primary completion
- Sep 2014 (Actual)
- Completion
- Sep 2014 (Actual)
- Last update posted
- Sep 9, 2016
2008 – 2014
United States locations
- U.S. sites
- 20
- U.S. states
- 16
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Mission Viejo | California | 92691 | — |
| Not listed | Newport Beach | California | 92660 | — |
| Not listed | Bridgeport | Connecticut | 06606 | — |
| Not listed | Melbourne | Florida | 32901 | — |
| Not listed | Winter Park | Florida | 32792 | — |
| Not listed | Chicago | Illinois | 60654 | — |
| Not listed | Kansas City | Kansas | 66160 | — |
| Not listed | Biddeford | Maine | 04005 | — |
| Not listed | Boston | Massachusetts | 02114 | — |
| Not listed | St Louis | Missouri | 63110 | — |
| Not listed | Concord | New Hampshire | 03301 | — |
| Not listed | New York | New York | 10032 | — |
| Not listed | Charlotte | North Carolina | 28204 | — |
| Not listed | Durham | North Carolina | 27710 | — |
| Not listed | Cincinnati | Ohio | 45212 | — |
| Not listed | Franklin | Ohio | 45005 | — |
| Not listed | Portland | Oregon | 97239 | — |
| Not listed | Nashville | Tennessee | 37232 | — |
| Not listed | Dallas | Texas | 75226 | — |
| Not listed | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00694109, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2016 · Synced Oct 27, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00694109 live on ClinicalTrials.gov.