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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PLx Pharma
ClinicalTrials.gov Identifier:
NCT01515657
First received: January 13, 2012
Last updated: June 29, 2012
Last verified: June 2012

January 13, 2012
June 29, 2012
January 2012
June 2012   (final data collection date for primary outcome measure)
Pharmacodynamic bioequivalence [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Serial measures of aspirin anti-platelet activity will be collected over 4 days, and compared between groups, to allow a determination of pharmcodynamic (anti-platelet) bioequivalance between study drugs.
Same as current
Complete list of historical versions of study NCT01515657 on ClinicalTrials.gov Archive Site
  • Safety and tolerability [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
    Assessment and comparison of the incidence of adverse events between treatment groups; changes in clinical laboratory parameters from baseline and between treatment groups; and changes in vital signs from baseline and between treatment groups.
  • Pharmacokinetic bioequivalance [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Serial measures of aspirin plasma levels will be collected over 4 days, and compared between groups, to allow a determination of pharmcokinetic bioequivalance between study drugs.
Same as current
Not Provided
Not Provided
 
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients
A Randomized, Actively Controlled, Crossover Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Patients With Type II Diabetes

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 elderly patients with diabetes.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Diabetes Mellitus, Type 2
  • Drug: PL2200 Aspirin Capsules
    325 mg aspirin; once per day for 3 days
  • Drug: Immediate-Release Aspirin Tablets
    325 mg aspirin; once per day for 3 days
  • Drug: Enteric-coated aspirin caplets
    325 mg aspirin; once per day for 3 days
  • Experimental: PL2200 Aspirin Capsules
    Investigational drug arm; crossover design
    Intervention: Drug: PL2200 Aspirin Capsules
  • Active Comparator: Immediate-Release Aspirin Tablets
    Active comparator; crossover design
    Intervention: Drug: Immediate-Release Aspirin Tablets
  • Active Comparator: Enteric-coated aspirin caplets
    Active comparator; crossover design
    Intervention: Drug: Enteric-coated aspirin caplets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults 50-79
  • Non-insulin-dependent type-2 diabetics

Exclusion Criteria:

  • Contraindications to aspirin
  • Significant disease history or active disease other than type-2 diabetes
  • Patient requires insulin
Both
50 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01515657
PL-ASA-004
No
PLx Pharma
PLx Pharma
Not Provided
Not Provided
PLx Pharma
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP