Clinical Trial Now Enrolling for Patients with Dilated Cardiomyopathy (DCM) due to Genetic Mutations or Unknown Causes
Bristol Myers Squibb is conducting a clinical trial in patients with DCM due to genetic mutations or unknown causes. Details of the study and eligibility requirements are listed below and participating in such research can help advance therapies for DCM.
But before discussing the BMS clinical trial/research study, we would like to better explain a little more about clinical trials (also called research studies).
First, what are clinical trials and how do they work?
Clinical trials are research studies that include human participants and explore how an investigational drug might act in the body and affect a disease. An “investigational drug” is a drug that is being researched. It is not yet approved by health authorities for doctors to prescribe to the general public.
What are the phases of a clinical trial?
Clinical trials are carried out in a series of steps, known as phases, to study whether the investigational drug is safe and effective for people to use.
A typical series of steps starts from early, small-scale, Phase 1 studies to late-stage, large-scale, Phase 3 studies.
During Phase 1, usually the shortest phase, researchers test an investigational drug for the first time in humans by giving it to a small number (20-80) of healthy volunteers to evaluate how the drug works in humans and identify side effects. The information from Phase 1 studies is important to the design of Phase 2 studies. In general, approximately 70% of drugs move to the next phase.
During Phase 2, the investigational drug is given to a larger number of people (100-300) who have a particular disease or condition to further evaluate the side effects and whether the drug works as treatment for a specific disease. (BMS is currently recruiting for phase 2 of a clinical trial in patients with DCM due to genetic mutations or unknown causes. Click here to learn more.)
During Phase 3, the investigational drug undergoes additional testing in people with the disease or condition to further evaluate the side effects, how well the drug works, how much of the drug people should take and how the drug compares to current standard treatments. Sometimes known as pivotal studies, these studies involve hundreds to thousands of participants. Phase 3 studies provide most of the safety data and usually take the most time to complete.
After Phase 3, health authorities, for example, the FDA in the US, thoroughly examine all submitted data on the investigational drug and decide to approve it or not to approve it.
As you can see, there are many required steps for a new drug to be developed and approved. This process takes 10-15 years on average.
After an investigational drug is approved and available by prescription, phase 4 clinical trials are sometimes conducted. In this phase, researchers are looking to understand the best way to use this drug as a treatment and whether there are any other risks or benefits associated with using this drug.
Considering Participating in a Research Study?
Have you considered participating in a clinical trial? Bristol Myers Squibb is conducting a phase 2 trial in patients ages 18 to 80 with DCM due to genetic mutations or unknown causes.
About This Research Study
Danicamtiv is an investigational drug being studied by Bristol Myers Squibb for dilated cardiomyopathy (DCM). Danicamtiv is being evaluated to see if it works on the heart muscle to help improve the function of the heart. Currently, the phase 2 clinical trial is ongoing in the US and parts of Europe in patients with DCM.
This trial is being conducted at 15 US locations to further understand the safety and cardiovascular effects of danicamtiv on the heart’s pumping ability.
Please click here, to visit BMS Study Connect to learn more about this study and take a simple 7-question pre-screener to see if you may pre-qualify for this study or other DCM research studies.
For more information, please call 855-907-3286 or email firstname.lastname@example.org.