Study Information for Participants Investigating a potential new treatment for high blood pressure
Quick Reference:
What is the purpose of this study?
Where is my nearest study site?
What is the purpose of this study?
This study aims to investigate if a single dose of ADX-850, a potential new drug for high blood pressure, is safe and well-tolerated in people with this condition. Researchers will explore how the body processes ADX-850, its effects, and any immune responses it may trigger. The results from this study will help determine if ADX-850 could be a more effective treatment for high blood pressure in the future.
Where is my nearest study site?
Here is a list of all of the sites who are currently recruiting for this study:
SA
- CMAX, Adelaide
WA
- Linear Research, Perth
Who can participate?
To take part in this study, you will need to meet all the following:
- Aged 18 to 65 years.
- History of mild to moderate hypertension with mean sitting systolic blood pressure of >130 and ≤160 mmHg.
- Body mass index (BMI) between 18.0 and 35.0 kg/m2.
- Body weight ≥55 kg.
Additional criteria apply and will be provided upon registration and pre-screening.
Who cannot participate?
Unfortunately, if any of the following apply to you, this study is not the right fit for you:
- Secondary hypertension (high blood pressure caused by another health problem).
- Active cancer and/or history of cancer in the last 5 years.
- Liver impairment and/or history of liver disease.
- Any moderate or severe active infection or acute illness.
- Major surgery or traumatic injury in the last 3 months.
Additional criteria apply and will be provided upon registration and pre-screening.
What is involved?
If you are deemed eligible for the study, and you agree to take part, your participation is expected to last approximately 57 weeks, and you will be required to attend the study site approximately 21 times. This includes:
- A Screening Visit up to 28 days prior to receiving the investigational treatment to assess your eligibility for the study. This visit will take approximately 3-4 hours.
- A 2-night confinement to the clinic, during which eligible participants will be randomised and administered the investigational treatment or a placebo.
- 18 follow-up visits at the study site on days 8, 15, 22, 29, 43, 57, 71, 85, 99, 127, 155, 183, 211, 239, 267, 295, 323, and 351.
- Home blood pressure monitoring in between study site visits.
- One end-of-treatment visit on day 365.
n in this research is voluntary, and you may withdraw from the study at any time.
If you take part in the research study, there will be:
-
Payment
You will be paid for your time and inconvenience
- Free study-related medical care: You may gain access to new research treatments, before they are widely available.
- Two nights overnight stays:
What is hypertension (high blood pressure)?
Hypertension, or high blood pressure, occurs when blood consistently pushes too hard against artery walls. It's diagnosed when systolic pressure consistently measures between 130-139 mmHg. Affecting over 1 in 3 Australian adults, hypertension is a major risk factor for heart disease, stroke, and kidney problems.
What causes hypertension (high blood pressure)?
Hypertension can be caused by various factors including family history, getting older, unhealthy diet, physical inactivity, and stress. Often called the "silent killer," high blood pressure typically doesn't cause noticeable symptoms until it reaches dangerous levels. This makes regular check-ups crucial for early detection and prevention of serious health complications.
Why is this study important?
This study investigates ADX-850, a potential new treatment for high blood pressure. ADX-850 temporarily reduces the production of angiotensinogen (AGT), a protein crucial for regulating blood pressure. By targeting the root cause of hypertension more precisely, ADX-850 may offer better effectiveness with potentially fewer side effects and less frequent dosing than current treatments. If successful, this could improve treatment adherence, which is crucial for managing chronic hypertension and enhancing overall health.
Who is involved?
This study is being sponsored by ADARx, a biotechnology company committed to turning cutting-edge science into life-saving therapeutics and bringing hope for people with intractable, hard-to-manage disease.
FOR MORE INFORMATION OR TO REGISTER YOUR INTEREST, VISIT TRIALS.EVRIMA.COM
This trial has been approved by an independent ethics committee
Ready to register? Click here to sign up/login to Evrilink and start your clinical trial journey.
Still have questions? Use the form below and one of our patient experience team members will be in touch to assist with your enquiry!