Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients
RITE
Reliable Inhibition of Thrombocyte Activity: Comparison of PL2200 Aspirin Capsules, 325 mg and Enteric-Coated Aspirin (RITE Study)
1 other identifier
interventional
57
1 country
3
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus-type-2
Started Jan 2014
Shorter than P25 for phase_3 diabetes-mellitus-type-2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
September 4, 2015
CompletedMarch 10, 2016
February 1, 2016
3 months
December 6, 2013
June 29, 2015
February 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
PL2200 Aspirin Capsules
EXPERIMENTALPL2200 Aspirin Capsules
Enteric-coated aspirin caplets
ACTIVE COMPARATOREnteric-coated aspirin caplets
Interventions
325 mg aspirin; once per day for 10 days
Eligibility Criteria
You may qualify if:
- Non-Insulin-Dependent Diabetes Mellitus
- Adults 21 to 79 years, inclusive
- Body mass index between 30 and 40 kg/m2, inclusive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PLx Pharmalead
Study Sites (3)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ronald Zimmerman, President & CEO
- Organization
- PLx Pharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2013
First Posted
December 11, 2013
Study Start
January 1, 2014
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
March 10, 2016
Results First Posted
September 4, 2015
Record last verified: 2016-02