The purpose of the HALO study is to find out if the study drug can safely lower blood pressure.
You may be able to join the HALO study if you meet the following study requirements:
- You are 18 years old or older with high blood pressure.*
- You already take 1 medication for high blood pressure.
- You may have high levels of aldosterone in your blood.*
*Your blood pressure and aldosterone levels will be measured as part of this study to find out if you qualify.
The HALO study lasts about 18 weeks (about 4 and a half months), and you can expect the following:
- Screening (up to 2 weeks) Visit the study clinic to have study assessments to find out if you qualify.
- Run-in (up to 4 weeks) Take a placebo tablet (no active ingredients) once a day in addition to your regular blood pressure medication.
- Dosing Part 1 (8 weeks) Be randomly assigned to take study drug or placebo tablets daily in addition to your regular blood pressure medication. Visit the study clinic 5 times for study assessments. If you meet certain requirements, you may be asked to participate in the next period of the study (Dosing Part 2). If not, you will skip to the Follow-up period.
- Dosing Part 2 (4 weeks) Continue taking the study drug (possibly at a higher dose) or placebo and stop taking your regular blood pressure medication. Visit the study clinic 3 times for study assessments. You may be asked to join a separate, related study and skip the Follow-up period of this study.
- Follow-up (2 weeks) Visit the study clinic one more time for final study assessments.
Participation in a clinical research study is voluntary. You can ask any questions you have, and you may leave the study at any time, for any reason.
