Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00770146 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on Therapy in High Risk Hypercholesterolemic Patients
A Phase 3 study, sponsored by Kastle Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 158
- Enrollment target
NCT00770146: Completed Phase 3 study, sponsored by Kastle Therapeutics.
NCT00770146 is a Phase 3 study that has completed, run by Kastle Therapeutics. The registered enrollment target is 158 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00770146, a Phase 3 study, has completed, sponsored by Kastle Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 158 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in patients with high cholesterol who are on a maximally tolerated dose of statin and who have a diagnosis that puts them at least at high risk of coronary heart disease (CHD).
Primary Outcome
LDL cholesterol was measured in mg/dL. Samples were taken following an overnight fast. LDL-C was obtained using Friedewald's calculation for patients with triglycerides ≤400 mg/dL and was directly measured by the central laboratory using ultracentrifugation for patients with triglycerides \>400 mg/dL. 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 | 158 participants |
| Start Date | 2008-11 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
What the finished NCT00770146 record still lists
NCT00770146 is an interventional study that assigns participants to a tested intervention. The registered 158 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 (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00770146 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00770146 about?
NCT00770146 is a clinical study titled "Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on Therapy in High Risk Hypercholesterolemic Patients". The purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in patients with high cholesterol who are on a maximally tolerated dose of statin and who have a diagnosis that puts them at least at high risk of coronary heart disease (CHD).
What is the current status of trial NCT00770146?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 158 participants. The study started on 2008-11. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00770146?
The interventions under investigation include: Placebo (DRUG), Mipomersen sodium (DRUG).
Who is sponsoring clinical trial NCT00770146?
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 NCT00770146's enrollment target sits among peer trials
158 1502nd of 2000 higher than 496 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
- NCT04486833 · 158 participants · Phase 1
Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib
- NCT04697966 · 158 participants · NA
Mechanisms and Predictors of Change in App-Based Mindfulness Training for Adolescents
- NCT04969835 · 158 participants · Phase 1
A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
- NCT05230732 · 158 participants · NA
Neuromodulation of Inflammation and Endothelial Function
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