Table of Contents
- Trial overview
- Study design and phase
- Who the trial was for
- Treatments studied
- Main outcome being measured
- Trial status and what it means
Trial overview
This clinical trial studied AMODIAQUINE in people with acute ischemic stroke, which is a sudden stroke caused by blocked blood flow to the brain.[1] The study was interventional, meaning researchers assigned treatments to participants instead of only observing care.[1]
Study design and phase
The trial was an open-label Phase 2b study with blinded evaluation.[1] Open-label means the treatment assignment was known in the study, while blinded evaluation means the result assessor did not know which treatment a patient received, helping reduce bias.[1]
The study was listed as Phase 2 and planned to enroll 150 participants.[1] Phase 2 trials usually look at early signs of benefit and safety in patients with the condition being studied.[1]
Who the trial was for
The target population was people with acute ischemic stroke.[1] The source data do not give more detailed eligibility rules, such as age limits or other inclusion criteria.[1]
Treatments studied
The trial compared investigational treatment combinations that included AMODIAQUINE with other drugs such as potassium canrenoate, exenatide, and glibenclamide.[1] The brief summary says the study aimed to compare the investigational treatment with best medical therapy, which means the usual standard care for the condition.[1]
- AMODIAQUINE plus glibenclamide was listed as an oral suspension in one study arm.[1]
- AMODIAQUINE was also listed as an intravenous solution in the source data.[1]
- Potassium canrenoate and exenatide were included in the intervention list as part of the treatment plan being tested.[1]
Main outcome being measured
The primary outcome was the percentage of patients with hemorrhagic transformation seen on CT or MRI.[1] Hemorrhagic transformation means bleeding changes in the area of stroke, and CT or MRI are imaging scans used to look at the brain.[1]
The brief summary says the main purpose was to evaluate the safety of the investigational treatment compared with best medical therapy, focusing on hemorrhagic transformation.[1]
Trial status and what it means
The trial status was Withdrawn.[1] This means the study was stopped before it could continue as planned, so the planned enrollment and study results were not carried forward in the source record.[1]
Because only one trial record is provided, the current clinical trial picture for AMODIAQUINE in the source data is limited to this withdrawn Phase 2 study in acute ischemic stroke.[1]
