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NCT01557335 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Platlet Aggregation of Clopidogrel, EC Aspirin 81 mg, EC Omeprazole 40 mg Compare to PA32540
A Phase 1 study, sponsored by POZEN.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01557335: Completed Phase 1 study, sponsored by POZEN.
NCT01557335 is a Phase 1 study that has completed, run by POZEN. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01557335, a Phase 1 study, has completed, sponsored by POZEN.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study is designed to provide data on platelet aggregation of PA32540 plus clopidogrel dosed separately compared to EC aspirin 81 mg plus EC omeprazole 40 mg plus clopidogrel dosed concomitantly.
Primary Outcome
To evaluate adenosine diphosphate (ADP)-induced platelet aggregation following administration of clopidogrel, EC aspirin 81 mg and EC omeprazole 40 mg, all dosed concomitantly, and PA32540 and clopidogrel dosed separately. The endpoint measure is IPA (Individual Platelet Aggregation)at day 7 and PA0 is the platelet aggregation at baseline. The IPA will be analyzed using analyses of variance (ANOVA).
Interventions
- DRUG Plavix® and PA32540
- DRUG EC aspirin (Bayer®) ,EC omeprazole (Prilosec®) , Clopidogrel (Plavix®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-02 |
| Phase | Phase 1 |
What the finished NCT01557335 record still lists
NCT01557335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Plavix® and PA32540 is the first listed.
NCT01557335 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01557335 about?
NCT01557335 is a clinical study titled "A Study to Evaluate Platlet Aggregation of Clopidogrel, EC Aspirin 81 mg, EC Omeprazole 40 mg Compare to PA32540". This study is designed to provide data on platelet aggregation of PA32540 plus clopidogrel dosed separately compared to EC aspirin 81 mg plus EC omeprazole 40 mg plus clopidogrel dosed concomitantly.
What is the current status of trial NCT01557335?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2010-11. Estimated completion is 2011-02.
What interventions are being tested in trial NCT01557335?
The interventions under investigation include: Plavix® and PA32540 (DRUG), EC aspirin (Bayer®) ,EC omeprazole (Prilosec®) , Clopidogrel (Plavix®) (DRUG).
Who is sponsoring clinical trial NCT01557335?
This trial is sponsored by POZEN, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01557335's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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