- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01515657
Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients
February 11, 2016 updated by: PLx Pharma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Cincinnati, Ohio, United States, 45212
- Medpace CLinical Pharmacology
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PL2200 Aspirin Capsules
Investigational drug arm; crossover design
|
325 mg aspirin; once per day for 3 days
|
Active Comparator: Immediate-Release Aspirin Tablets
Active comparator; crossover design
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325 mg aspirin; once per day for 3 days
|
Active Comparator: Enteric-coated aspirin caplets
Active comparator; crossover design
|
325 mg aspirin; once per day for 3 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to 99% Inhibition of Serum Thromboxane (TxB2)
Time Frame: 4 days
|
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.
|
4 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
January 13, 2012
First Submitted That Met QC Criteria
January 18, 2012
First Posted (Estimate)
January 24, 2012
Study Record Updates
Last Update Posted (Estimate)
March 14, 2016
Last Update Submitted That Met QC Criteria
February 11, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- PL-ASA-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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