Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00706849 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease
A Phase 3 study, sponsored by Kastle Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 124
- Enrollment target
NCT00706849: Completed Phase 3 study, sponsored by Kastle Therapeutics.
NCT00706849 is a Phase 3 study that has completed, run by Kastle Therapeutics. The registered enrollment target is 124 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00706849, a Phase 3 study, has completed, sponsored by Kastle Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 124 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether mipomersen safely and effectively lowers low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial Hypercholesterolemia (HeFH) and coronary artery disease (CAD) who are already on a stable dose of other lipid-lowering agents (including maximally tolerated statin therapy).
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. The primary efficacy time point was the post-baseline visit closest to 14 days after the last dose of study treatment.
Interventions
- DRUG placebo
- DRUG mipomersen sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2008-07 |
| Est. Completion | 2010-05 |
| Phase | Phase 3 |
What the finished NCT00706849 record still lists
NCT00706849 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00706849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00706849 about?
NCT00706849 is a clinical study titled "Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease". The purpose of this study is to determine whether mipomersen safely and effectively lowers low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial Hypercholesterolemia (HeFH) and coronary artery disease (CAD) who are already on a stable dose of other lipid-lowering agents ...
What is the current status of trial NCT00706849?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 124 participants. The study started on 2008-07. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00706849?
The interventions under investigation include: placebo (DRUG), mipomersen sodium (DRUG).
Who is sponsoring clinical trial NCT00706849?
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 NCT00706849's enrollment target sits among peer trials
124 1610th of 2000 higher than 386 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02523014 · 124 participants · Phase 2
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
- NCT02670707 · 124 participants · Phase 3
Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)
- NCT02830724 · 124 participants · Phase 1
Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers
- NCT04748809 · 124 participants · NA
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia