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AT-001 for Diabetic Cardiomyopathy
Study Summary
This trial will test a new medication to see if it can help people with diabetic cardiomyopathy who are at high risk for heart failure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have heart problems related to diabetes.I have heart problems due to diabetes.I need treatment for a serious heart valve problem.I have a serious irregular heartbeat.I have Type 2 Diabetes.My exercise capacity is less than 75% of what's expected for my age and gender.I have heart problems related to diabetes.I have Type 2 Diabetes.Your blood pressure is higher than 140 over 90 at the initial check-up.Your HbA1c level is higher than 8.5%.I have been diagnosed with a specific heart muscle condition before.I have had heart issues like a heart attack, bypass surgery, stent placement, or stroke.I have Type 2 Diabetes.My exercise capacity is below 75% of what's expected for my age and gender.Your heart's ejection fraction was measured to be less than 40% in a previous echocardiogram.I have a severe condition that affects my ability to do a cardio-pulmonary exercise test.I have been diagnosed with or show signs of advanced heart failure.I have Type 2 Diabetes.
- Group 1: AT-001 High dose
- Group 2: Placebo Comparator
- Group 3: AT-001 Low Dose
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any short-term or long-term risks associated with taking AT-001?
"AT-001 has received a safety rating of 3. This is due to the fact that it is a Phase 3 trial, and there is thus some data supporting both efficacy and safety."
Is this research still looking for new participants?
"The information available on clinicaltrials.gov indicates that this trial is still actively recruiting patients. The trial was first posted on September 20th, 2019 and was last updated on February 25th, 2022. There are 38 different recruitment sites across the globe and the study is looking for 675 participants in total."
Have these treatments been tested before on humans?
"AT-001 is being tested in 2 ongoing trials, which began in 2019. The trials, conducted in 45 cities across 10 countries, have recruited 675 and 18241 participants, respectively. The sponsor of these trials is Applied Therapeutics, Inc."
What other drugs have been trialed with AT-001?
"There are 2 ongoing clinical trials for AT-001, with 1 of them being in Phase 3. Even though the majority of research for AT-001 is based in Houston, Texas, there are actually 81 clinical trial sites for this medication."
Is this clinical trial active in several hospitals across Canada?
"There are 38 clinical trial sites available for this study, including the Centre for Studies in Family Medicine, the Western Centre for Public Health and Family Medicine, and Western University in London, Ecogene-21 in Chicoutimi, and BC Diabetes in Vancouver."
How many patients are being monitored in this clinical trial?
"In order to run this clinical trial, 675 individuals that meet the pre-determined inclusion criteria are required to enroll. These potential patients can come from various recruitment sites, such as the Centre for Studies in Family Medicine, Western Centre for Public Health and Family Medicine, Western University in London, Ontario and Ecogene-21 in Chicoutimi, Quebec."
Who else is applying?
What state do they live in?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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How responsive is this trial?
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Most responsive sites:
- Progressive Medical Research: < 48 hours
Average response time
- < 2 Days
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