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NCT00794664 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis
A Phase 3 study, sponsored by Kastle Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 58
- Enrollment target
NCT00794664: Completed Phase 3 study, sponsored by Kastle Therapeutics.
NCT00794664 is a Phase 3 study that has completed, run by Kastle Therapeutics. The registered enrollment target is 58 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00794664, a Phase 3 study, has completed, sponsored by Kastle Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 58 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in treating severely hypercholesterolemic patients who are on a maximally tolerated lipid-lowering regimen and who are not on apheresis.
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 | 58 participants |
| Start Date | 2009-01 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
What the finished NCT00794664 record still lists
NCT00794664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00794664 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00794664 about?
NCT00794664 is a clinical study titled "Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis". The purpose of the study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in treating severely hypercholesterolemic patients who are on a maximally tolerated lipid-lowering regimen and who are not on apheresis.
What is the current status of trial NCT00794664?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 58 participants. The study started on 2009-01. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00794664?
The interventions under investigation include: Placebo (DRUG), Mipomersen (DRUG).
Who is sponsoring clinical trial NCT00794664?
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 NCT00794664's enrollment target sits among peer trials
58 1825th of 2000 higher than 174 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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