In short
Clinical trials are investigating AMODIAQUINE in people with acute ischemic stroke. These studies aim to assess safety and effects on bleeding changes in the brain, using blinded evaluation in a phase 2 trial. The trial information below focuses on the study design, target patients, and main outcome being measured.
Key points
- Clinical trial data for AMODIAQUINE show one interventional study in acute ischemic stroke. The study was an open-label Phase 2b trial with blinded evaluation and planned enrollment of 150 people. It aimed to compare the investigational treatment with best medical therapy and measure hemorrhagic transformation on CT or MRI. The trial status is Withdrawn, so it did not continue as planned. The source data focus on safety and brain bleeding outcomes in stroke patients.
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. The study was interventional, meaning researchers assigned treatments to participants instead of only observing care.
Study design and phase
The trial was an open-label Phase 2b study with blinded evaluation. 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.
The study was listed as Phase 2 and planned to enroll 150 participants. Phase 2 trials usually look at early signs of benefit and safety in patients with the condition being studied.
Who the trial was for
The target population was people with acute ischemic stroke. The source data do not give more detailed eligibility rules, such as age limits or other inclusion criteria.
Treatments studied
The trial compared investigational treatment combinations that included AMODIAQUINE with other drugs such as potassium canrenoate, exenatide, and glibenclamide. 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.
- AMODIAQUINE plus glibenclamide was listed as an oral suspension in one study arm.
- AMODIAQUINE was also listed as an intravenous solution in the source data.
- Potassium canrenoate and exenatide were included in the intervention list as part of the treatment plan being tested.
Main outcome being measured
The primary outcome was the percentage of patients with hemorrhagic transformation seen on CT or MRI. Hemorrhagic transformation means bleeding changes in the area of stroke, and CT or MRI are imaging scans used to look at the brain.
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.
Trial status and what it means
The trial status was Withdrawn. 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.
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.