Join a clinical study testing the effects of an investigational oral drug on blood pressure.
What is a clinical study?
A clinical study (also known as a clinical trial) is designed to learn more about a drug’s safety and ability to treat a specific disease or condition. Regulatory agencies and health authorities use the results of clinical studies to decide if an investigational drug should be made available to patients and how approved drugs should be prescribed. Every clinical study is reviewed by an Institutional Review Board (IRB), which helps ensure that the study is conducted safely and that the rights of study participants are protected. Clinical studies are conducted by trained medical professionals who monitor the health of participants throughout the study.
Clinical studies are the only way we can develop new and better treatments and improve patient care.
What is the purpose of this study?
We are doing this study to learn more about a study drug called AZD0780 and how it affects blood pressure. Additional goals of the study are to better understand certain medical conditions and other associated health problems.
What is the study drug?
The study drug, AZD0780, works by blocking a protein called PCSK9, which plays a crucial role in regulating blood cholesterol levels. Lowering blood cholesterol levels may lower someone’s risk of having a cardiovascular event like a heart attack or stroke. AZD0780 is not approved by any health authority, except for use in research studies like this one. During the study, the study drug is provided as tablets taken once per day by mouth with a glass of water.
Who can be in the study?
To be considered for the study, participants must meet these and other criteria:
• 18 years of age or older
• Diagnosed with some form of atherosclerotic cardiovascular disease (ASCVD) such as heart attack (myocardial infarction), stroke, hardening of the arteries (symptomatic peripheral arterial disease), or certain risk factors for ASCVD
• Have been on stable standard of care treatment for the 4 weeks before joining the study
Your medical history and other criteria will be checked to see if you can take part in the study.
What is involved in the study?
Approximately 172 participants will join the study at research clinics across the United States. The study lasts about 3 months and is divided into 5 parts:
| 1 | Screening (up to 7 days) |
First, you will undergo a series of tests to find out if you can join the study. This is called screening. If you don’t meet the screening criteria, the reasons will be explained. |
| 2 | Intervention Period 1 (29 days) |
First, you will undergo a series of tests to find out if you can join the study. This is called screening. If you don’t meet the screening criteria, the reasons will be explained. |
| 3 | Washout Period (14 days) |
After Intervention Period 1 you will enter a “washout period” in which you will not receive any study drug or placebo. This period is intended to allow any study drug to be eliminated completely from your body. |
| 4 | Intervention Period 2 (29 days) |
During this period, your study treatment will switch. So, if you previously received placebo, you will now receive study drug. And if you previously received study drug, you will receive placebo during Intervention Period 2. You will have 5 more clinic visits during this period. |
| 5 | Follow-up Period (14 days) |
Approximately 2 weeks after you stop study |
At four different time points during the study, you will continuously wear an ambulatory blood pressure monitoring device, or ABPM, for about 25 hours. This means that for 25 hours you will wear an arm cuff that will inflate 2 times per hour to measure your blood pressure. This is one of the most important
parts of the study, so it will be critical that you wear the device as instructed. You will also be provided with a study diary to keep track of your sleep schedule on certain days, symptoms, study treatment dosing, and any new or worsening medical problems during the Intervention Periods.
Should I participate in the study?
There is no certainty that you will have any benefit from taking part in the study. The information collected during this study may help doctors better treat patients with cardiovascular conditions and high cholesterol in the future.
Taking part in a clinical study is completely voluntary. Participation is not required and, if enrolled, you can choose to end your participation at any time and for any reason.
Will the study cost me anything?
Participating in this study will not cost you anything. Study drugs, study visits, and study-related tests and examinations are provided at no cost. You may also be reimbursed for reasonable study-related expenses such as travel or parking.
How can I learn more about this study?
To ask questions or find out if you could participate, please contact:
Every day, clinical research uncovers new information about medical conditions and their treatment. Volunteer involvement in clinical studies is a key part in the development and advancement of future therapies. Results collected from clinical studies have led to thousands of medications and devices becoming available to patients all over the world.
