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: February 11, 2016
Last verified: February 2016

January 13, 2012
February 11, 2016
January 2012
June 2012   (final data collection date for primary outcome measure)
Time to 99% Inhibition of Serum Thromboxane (TxB2) [ Time Frame: 4 days ] [ Designated as safety issue: No ]
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.
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.
Complete list of historical versions of study NCT01515657 on ClinicalTrials.gov Archive Site
Not Provided
  • 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.
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 patients with diabetes.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (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 21-79
  • Body mass index (BMI) of 30-40 kg/m2
  • Non-insulin-dependent type-2 diabetics (as confirmed by hemoglobin A1c (HbA1c) of > 6.4% and/or fasting plasma glucose of >125 mg/dL or current anti-diabetic medication)
  • AA-induced platelet aggregation response of >60% within 3 hours prior to initial dose of study drug administration

Exclusion Criteria:

  • Contraindications to aspirin
  • Previous history of vascular disease
  • Patient requires insulin
  • Use of non-steroidal anti-inflammatory drugs, anti-secretory agents, antacids, and salicylate-containing nutritional supplements within 2 weeks of randomization
Both
21 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01515657
PL-ASA-004
No
Not Provided
Not Provided
PLx Pharma
PLx Pharma
Not Provided
Not Provided
PLx Pharma
February 2016

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