Are you Unable to Take Statins for your High Cholesterol?

If you are unable to take statin medication to lower your cholesterol, you may be able to participate in the CLEAR Outcomes study at Hunter Diabetes Centre.

The CLEAR Outcomes Study will include more than 12,000 people worldwide who have, or are at high risk of, cardiovascular disease (also known as heart disease), and cannot tolerate taking cholesterol-lowering medications called statins.

The main purpose of the CLEAR Outcomes study is to see if an investigational medication reduces the risk of major cardiovascular (heart and blood vessel-related) events in participants with, or at high risk for, cardiovascular disease. The study will also look at how the investigational medication may affect the level of cholesterol and how safe it is.

What is a clinical research study? Clinical research studies help to determine whether potential new medications (known as “investigational medications”) are safe and how well they work. In a clinical research study, a group of people agree to take the investigational medication while being looked after by study doctors, nurses and other staff. Clinical research studies provide the best information for health-related decision-making, new medications and new treatments.

Can I take part? You may be able to take part in the CLEAR Outcomes study if you:

• are over 18 years of age

• have, or at high risk for, cardiovascular disease

• cannot tolerate taking statin medications (have tried two or more statin medications, but you had problems taking them because of side effects)

Please note that, while we are a diabetes specialist centre, you do not need to have diabetes to participate in this study.

What’s involved? The CLEAR Outcomes Study will last for 2-5 years, with an average length of 3-5 years. This will begin with regular visits to Hunter Diabetes Centre, moving onto three monthly visits and phone calls. There will be some health checks and tests performed at study visits, and our experienced research team will closely monitor you.

What else do I need to consider? Taking part in the CLEAR Outcomes study is your choice. The study team will explain the risks and benefits of taking part in the study. Study medication and tests will be provided at no cost.

Who should I contact for more information? If you are interested in learning more about the CLEAR Outcomes study, please contact the Hunter Diabetes Centre research team on 4963 2323 (take option 1) or email kate@hunterdiabetes.com.au.