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NCT00477594 · ClinicalTrials.gov registry record · Phase 2
Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia
A Phase 2 study, sponsored by Kastle Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT00477594: Completed Phase 2 study, sponsored by Kastle Therapeutics.
NCT00477594 is a Phase 2 study that has completed, run by Kastle Therapeutics. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00477594, a Phase 2 study, has completed, sponsored by Kastle Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
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.
Primary Outcome
LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. For patients with triglycerides \<400 mg/dL, LDL-C was obtained using Friedewald's calculation; and for patients with triglycerides ≥400 mg/dL, LDL-C was directly measured by the central laboratory using ultracentrifugation. For patients who were on placebo in the index study or who took their last dose of mipomersen ≥6 months prior to first dose in this study, Baseline is defined as the last measurement prior
Interventions
- DRUG mipomersen sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2007-05 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
What the finished NCT00477594 record still lists
NCT00477594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which mipomersen sodium is the first listed.
NCT00477594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00477594 about?
NCT00477594 is a clinical study titled "Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia". 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.
What is the current status of trial NCT00477594?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2007-05. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00477594?
The interventions under investigation include: mipomersen sodium (DRUG).
Who is sponsoring clinical trial NCT00477594?
This trial is sponsored by Kastle Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00477594's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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