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NCT01486433 · ClinicalTrials.gov registry record · Phase 1
The Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects
A Phase 1 study of Hypertriglyceridemia, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT01486433: Completed Phase 1 study of Hypertriglyceridemia, sponsored by AstraZeneca.
NCT01486433 is a Phase 1 study of Hypertriglyceridemia that has completed, run by AstraZeneca. The registered enrollment target is 52 participants, below the 174-participant average among 25 other Hypertriglyceridemia trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01486433, a Phase 1 study of Hypertriglyceridemia, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective is to determine the effect of multiple doses of Epanova® (omega fatty acids) on the pharmacokinetics (PK) of multiple 40 mg doses of simvastatin.
Primary Outcome
Area under the plasma concentration versus time curve (AUC0-tau)for simvastatin and beta- hydroxysimvastatin acid, measured over the 24 hour period after the 14th dose
Conditions Studied
Interventions
- DRUG Simvastatin
- DRUG omefas
- DRUG acetylsalicylic acid (ASA)
Study Locations (1)
Arizona
- - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
What the finished NCT01486433 record still lists
NCT01486433 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 174-participant average among 25 other Hypertriglyceridemia trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Hypertriglyceridemia appearing as the primary indexed condition, and to 3 interventions - of which Simvastatin is the first listed.
NCT01486433 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT01486433 about?
NCT01486433 is a clinical study titled "The Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects". The primary objective is to determine the effect of multiple doses of Epanova® (omega fatty acids) on the pharmacokinetics (PK) of multiple 40 mg doses of simvastatin.
What is the current status of trial NCT01486433?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2011-11. Estimated completion is 2012-03.
What conditions does trial NCT01486433 study?
This clinical trial studies the following conditions: Hypertriglyceridemia.
What interventions are being tested in trial NCT01486433?
The interventions under investigation include: Simvastatin (DRUG), omefas (DRUG), acetylsalicylic acid (ASA) (DRUG).
Who is sponsoring clinical trial NCT01486433?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01486433 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypertriglyceridemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01486433's enrollment target sits among peer trials
52 12th of 25 higher than 13 of 25 other Hypertriglyceridemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertriglyceridemia 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.
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