A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol
Public ClinicalTrials.gov record NCT01475825. 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
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Followed by an Open-Label Continuation Period to Assess the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol
Study identification
- NCT ID
- NCT01475825
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Kastle Therapeutics, LLC
- Industry
- Enrollment
- 309 participants
Conditions and interventions
Conditions
Interventions
- mipomersen sodium 200 mg Drug
- Placebo Drug
- mipomersen sodium 70 mg Drug
Drug
Eligibility (public fields only)
- Age range
- 18 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
- Nov 30, 2011
- Primary completion
- Dec 28, 2015
- Completion
- Dec 28, 2015
- Last update posted
- Mar 25, 2019
2011 – 2015
United States locations
- U.S. sites
- 20
- U.S. states
- 18
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Mission Viejo | California | — | — |
| Not listed | Aurora | Colorado | — | — |
| Not listed | Cooper City | Florida | — | — |
| Not listed | Winter Park | Florida | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Kansas City | Kansas | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Ann Arbor | Michigan | — | — |
| Not listed | Grandville | Michigan | — | — |
| Not listed | Rochester | Minnesota | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Omaha | Nebraska | — | — |
| Not listed | Summit | New Jersey | — | — |
| Not listed | North Massapequa | New York | — | — |
| Not listed | Portland | Oregon | — | — |
| Not listed | Lancaster | Pennsylvania | — | — |
| Not listed | Charleston | South Carolina | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Norfolk | Virginia | — | — |
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 93 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01475825, 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 Mar 25, 2019 · Synced Jul 22, 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 protocol, eligibility criteria, and contact information for NCT01475825 live on ClinicalTrials.gov.