NCT02008942

Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients

Reliable Inhibition of Thrombocyte Activity: Comparison of PL2200 Aspirin Capsules, 325 mg and Enteric-Coated Aspirin (RITE Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: PLx Pharma · Industry
• Sex: All
• Age: 21 Years – 79 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	PL2200 Aspirin Capsules	325 mg aspirin; once per day for 10 days
DRUG	Enteric-coated aspirin caplets	325 mg aspirin; once per day for 10 days

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-12-11
• Last updated: 2016-03-10
• Results posted: 2015-09-04

Locations

3 sites across 1 country: United States