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NCT00607373 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia
A Phase 3 study, sponsored by Kastle Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
NCT00607373: Completed Phase 3 study, sponsored by Kastle Therapeutics.
NCT00607373 is a Phase 3 study that has completed, run by Kastle Therapeutics. The registered enrollment target is 51 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00607373, a Phase 3 study, has completed, sponsored by Kastle Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of mipomersen (ISIS 301012) in subjects with homozygous familial hypercholesterolemia on lipid-lowering therapy. This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up period. Following treatment and Week 28 evaluations, participants could elect to enroll in an open-label extension study (301012-CS6; NCT00694109). Participants who were not eligible or elected not to enroll in the open-label extension study or who discontinued during the 28-week treatment period were followed in this study for 24 weeks from administration of the last dose of study drug.
Primary Outcome
LDL-C 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. Baseline was defined as the average of the screening and Study Day 1 (pre-treatment) assessments. An assessment was not included in this calculation if it was associated with a non-fasting blood d
Interventions
- DRUG Placebo
- DRUG mipomersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2007-07 |
| Est. Completion | 2009-03 |
| Phase | Phase 3 |
What the finished NCT00607373 record still lists
NCT00607373 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00607373 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00607373 about?
NCT00607373 is a clinical study titled "Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia". The purpose of this study is to evaluate the safety and efficacy of mipomersen (ISIS 301012) in subjects with homozygous familial hypercholesterolemia on lipid-lowering therapy. This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up period. Following treatment and...
What is the current status of trial NCT00607373?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2007-07. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00607373?
The interventions under investigation include: Placebo (DRUG), mipomersen (DRUG).
Who is sponsoring clinical trial NCT00607373?
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 NCT00607373's enrollment target sits among peer trials
51 1842nd of 2000 higher than 157 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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