At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 117 enrolled
Drug / intervention
Naproxen Sodium (Aleve, BAY117031) +1 moredrug
Likely dose
Naproxen Sodium (Aleve, BAY117031) 220 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open Label, Parallel Group Study to Investigate the Effects on Serum Thromboxane by the Addition of Naproxen Sodium to Aspirin Therapy Versus Aspirin Therapy Alone
In Brief
A Phase 1 clinical trial evaluating Naproxen Sodium (Aleve, BAY117031) and Acetylsalicylic Acid (Aspirin, BAYE4465) for Hematology. Completed, enrolled 117 participants across 1 site.
Detailed Summary
To determine if administration of naproxen sodium 220 mg maintains the platelet inhibitory effect of a low dose Immediate Release Aspirin (IR ASA) regimen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematology
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartFeb 2015
Primary CompletionMay 2015
TodayJul 2026
First PostedSep 1, 2014
Enrollment StartFeb 1, 2015
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.8 years ago
Interventions
Naproxen Sodium (Aleve, BAY117031)drug
Naproxen sodium 220 mg qd or bid
Acetylsalicylic Acid (Aspirin, BAYE4465)drug
ASA 81 mg qd