At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 421 enrolled
Drug / intervention
Uric Acid +1 moredrug
Likely dose
Uric Acid 500 mlfrom 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.
Randomized, Double Blind Study Assessing the Clinical Efficacy of Combined Treatment With Uric Acid and rtPA Administered Intravenously in Acute Ischemic Stroke Patients Within the First 4.5 Hours of Symptoms Onset
In Brief
A Phase 3 clinical trial evaluating Uric Acid and Vehicle for Acute Ischemic Stroke. Completed, enrolled 421 participants across 10 sites.
Detailed Summary
The purpose of this study is to determine whether the combined treatment with Uric Acid and rtPA is superior to rtPA alone in terms of clinical efficacy in acute ischemic stroke patients treated within the first 4.5 hours of symptoms onset.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Ischemic Stroke
CountriesSpain
CollaboratorsCarlos III Health Institute
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2009
Enrollment StartJun 2011
Primary CompletionAug 2013
Study CompletionOct 2013
TodayJul 2026
First PostedMar 12, 2009
Enrollment StartJun 1, 2011
Primary CompletionAug 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.3 years ago
Interventions
Uric Aciddrug
1 gram dissolved in a vehicle containing 500 ml of 0'1% Lithium Carbonate and 5% Mannitol, IV (in the vein), single dose.
Vehicleother
Single intravenous infusion of a 500 ml vehicle containing 0'1% Lithium Carbonate and 5% Mannitol.