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NCT01431105 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities
A Phase 1 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01431105: Completed Phase 1 study, sponsored by University of California, San Diego.
NCT01431105 is a Phase 1 study that has completed, run by University of California, San Diego. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01431105, a Phase 1 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that could lead to complications later in life, including heart attack. Although investigators can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Inflammation and damage to the arterial wall is central to these coronary artery abnormalities. Statins, a class of drugs that is known for lowering cholesterol, have also been shown to decrease inflammation in general as well as at the level of the vessel wall. Therefore, the investigators propose to study the safety of the drug atorvastatin in children with coronary artery abnormalities from KD.
Primary Outcome
Number of participants who experienced an SAE within the 6 week study period
Interventions
- DRUG Atorvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2012-07 |
| Est. Completion | 2018-07 |
| Phase | Phase 1 |
What the finished NCT01431105 record still lists
NCT01431105 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which Atorvastatin is the first listed.
NCT01431105 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01431105 about?
NCT01431105 is a clinical study titled "Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities". Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that could lead to complications later in life, including heart...
What is the current status of trial NCT01431105?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2012-07. Estimated completion is 2018-07.
What interventions are being tested in trial NCT01431105?
The interventions under investigation include: Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT01431105?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01431105's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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