A Phase 1 interventional study of Aspirin and Durlaza™ in Cardiovascular Disease, sponsored by New Haven Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-06.
Sponsored by New Haven Pharmaceuticals, Inc. · Phase 1, Interventional, and Basic science
This study is being conducted to evaluate the safety and the length of effect on platelet build-up in the arteries of Durlaza™ as compared to immediate-release Bayer® aspirin 81 mg or subject's current aspirin 81 mg of choice in patients who have Type 2 diabetes mellitus and cardiovascular disease or multiple risk factors of developing cardiovascular disease.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 41 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →This is the only study on the registry with New Haven Pharmaceuticals, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Aspirin run-in, followed with Durlaza™, one capsule QD (quaque die), for 14 ± 4 days and an in-patient visit
Drug: Aspirin · Drug: Durlaza™
in a rollover with 10 subjects from the first arm, an aspirin run-in, followed by Durlaza™, two capsules QD, for 14 ± 4 days and an in-patient visit
Drug: Aspirin · Drug: Durlaza™
steady-state run-in prior to Durlaza treatment
Also known as: Bayer aspirin
comparison of different numbers of capsules
change in platelet aggregation
Time frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints
Reactive Hyperemia Index
Time frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints
Safety as measured by the number and system class of adverse events reported in each treatment arm
Time frame: participants are followed for approximately 40 to 65 days once they start study medication
Serum Thromboxane
Time frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints
urinary metabolites of prostacyclin and thromboxane
Time frame: During the 26-hour hospital stays, outcomes will be measured at various timepoints
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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