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NCT01515657 · ClinicalTrials.gov registry record · Phase 3
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients
A Phase 3 study, sponsored by PLx Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
NCT01515657: Completed Phase 3 study, sponsored by PLx Pharma.
NCT01515657 is a Phase 3 study that has completed, run by PLx Pharma. The registered enrollment target is 40 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01515657, a Phase 3 study, has completed, sponsored by PLx Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as plain aspirin and enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as these other products, when administered to patients with diabetes.
Primary Outcome
Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy.
Interventions
- DRUG PL2200 Aspirin Capsules
- DRUG Enteric-coated aspirin caplets
- DRUG Immediate-Release Aspirin Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
What the finished NCT01515657 record still lists
NCT01515657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which PL2200 Aspirin Capsules is the first listed.
NCT01515657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01515657 about?
NCT01515657 is a clinical study titled "Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients". This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as plain aspirin and enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as these other products, when administered to patients with diabet...
What is the current status of trial NCT01515657?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2012-01. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01515657?
The interventions under investigation include: PL2200 Aspirin Capsules (DRUG), Enteric-coated aspirin caplets (DRUG), Immediate-Release Aspirin Tablets (DRUG).
Who is sponsoring clinical trial NCT01515657?
This trial is sponsored by PLx Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01515657's enrollment target sits among peer trials
40 1878th of 2000 higher than 103 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
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