Study Drug

What is the study drug?

The study drug in the HALO study is an investigational drug designed to reduce the amount of aldosterone the body produces. Reducing aldosterone may reduce the amount of sodium and water in the blood and lead to a lower blood pressure.

What is an investigational drug?

An investigational drug is one that has not yet been evaluated by the US Food and Drug Administration (FDA) and can only be used in clinical research studies.

How does the study drug work?

The following represents how the study drug may work:

Will I receive the study drug if I join the study?

You may or may not receive the study drug in the first part of the study (Dosing Part 1). You will have another chance to receive the study drug in the second part of the study (Dosing Part 2) if you meet certain requirements.

Dosing Part 1

• You have a 3 in 4 chance of receiving the study drug.
• You have a 1 in 4 chance of receiving a placebo, which has no active drug ingredients.
• You will continue taking your regular blood pressure medication during this part of the study.

Dosing Part 2

• You will receive the study drug if you meet certain requirements during Dosing Part 1.
• There is a chance you will receive a higher dose of the study drug than you received in Dosing Part 1.
• You will stop taking your regular blood pressure medication during this part of the study.

Have other people used the study drug?

Yes, the study drug has been tested in 5 previous clinical research studies. Results showed that the study drug was generally well tolerated, but more research is needed.