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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PLx Pharma
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Non-Insulin-Dependent Diabetes Mellitus

• Adults 21 to 79 years, inclusive

• Body mass index between 30 and 40 kg/m2, inclusive

Exclusion Criteria:

• Currently prescribed aspirin or anti-coagulants

• Contraindications to aspirin

• Significant disease history or active disease other than Non-Insulin-Dependent Diabetes Mellitus

• Patient requires insulin