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NCT01499420 · ClinicalTrials.gov registry record · Phase 2
A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients
A Phase 2 study, sponsored by CSL Limited.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT01499420: Completed Phase 2 study, sponsored by CSL Limited.
NCT01499420 is a Phase 2 study that has completed, run by CSL Limited. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01499420, a Phase 2 study, has completed, sponsored by CSL Limited.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS) may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent cardiovascular events. This study is a multi-center, randomized, placebo-controlled, single ascending dose study in patients with stable atherothrombotic disease in whom the safety and pharmacokinetic profile of CSL112 will be assessed.
Primary Outcome
The frequency of study product-related adverse events
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL CSL112 (reconstituted high density lipoprotein)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
What the finished NCT01499420 record still lists
NCT01499420 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01499420 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01499420 about?
NCT01499420 is a clinical study titled "A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients". Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS) may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent cardiovascular events. This study is a multi-center, randomized, placebo-controlled, single ascending dose study in patients wit...
What is the current status of trial NCT01499420?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2012-02. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01499420?
The interventions under investigation include: Placebo (BIOLOGICAL), CSL112 (reconstituted high density lipoprotein) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01499420?
This trial is sponsored by CSL Limited, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01499420's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 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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