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NCT02008942 · ClinicalTrials.gov registry record · Phase 3
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by PLx Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 57
- Enrollment target
- 3
- Study locations
NCT02008942: Completed Phase 3 study of Diabetes Mellitus, Type 2, sponsored by PLx Pharma.
NCT02008942 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by PLx Pharma. The registered enrollment target is 57 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02008942, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by PLx Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 57 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as enteric coated aspirin, when administered to patients with diabetes
Primary Outcome
Serial measurements of aspirin anti-platelet activity will be collected over 11 days, and compared between groups, to allow a determination of pharmacodynamic (anti-platelet) bioequivalence between study drugs. 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.
Conditions Studied
Interventions
- DRUG PL2200 Aspirin Capsules
- DRUG Enteric-coated aspirin caplets
Study Locations (3)
Florida
- Miami Research Associates - Miami
Kansas
- PRA Clinical Pharmacology Center - Lenexa
Ohio
- Medpace Clinical Pharmacology - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
What the finished NCT02008942 record still lists
NCT02008942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which PL2200 Aspirin Capsules is the first listed.
NCT02008942 reports a single indexed study location in Florida, Kansas, Ohio.
Frequently Asked Questions
What is clinical trial NCT02008942 about?
NCT02008942 is a clinical study titled "Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients". This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as enteric coated aspirin, when administered to patients with diabetes
What is the current status of trial NCT02008942?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 57 participants. The study started on 2014-01. Estimated completion is 2014-04.
What conditions does trial NCT02008942 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT02008942?
The interventions under investigation include: PL2200 Aspirin Capsules (DRUG), Enteric-coated aspirin caplets (DRUG).
Who is sponsoring clinical trial NCT02008942?
This trial is sponsored by PLx Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02008942 being conducted?
This trial has 3 study locations across Florida, Kansas, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
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 NCT02008942's enrollment target sits among peer trials
57 252nd of 348 higher than 97 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 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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