| Trial ID: | L5436 |
| Source ID: | NCT02008942
|
| Associated Drug: |
Pl2200 Aspirin Capsules
|
| Title: |
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients
|
| Acronym: |
RITE
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02008942/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: PL2200 Aspirin Capsules|DRUG: Enteric-coated aspirin caplets
|
| Outcome Measures: |
Primary: Time to 99% Inhibition of Serum Thromboxane, 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., 11 days |
|
| Sponsor/Collaborators: |
Sponsor: PLx Pharma
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
57
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2014-01
|
| Completion Date: |
2014-04
|
| Results First Posted: |
2015-09-04
|
| Last Update Posted: |
2016-03-10
|
| Locations: |
Miami Research Associates, Miami, Florida, 33143, United States|PRA Clinical Pharmacology Center, Lenexa, Kansas, 66219, United States|Medpace Clinical Pharmacology, Cincinnati, Ohio, 45227, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02008942
|
