The High Blood Pressure Treatment Study
High blood pressure? Consider a new research study investigating potential treatment options.
We’re inviting adults aged between 18 and 65 years with mild to moderate high blood pressure to participate in this important research. If you're concerned about your blood pressure or have risk factors like stress, poor diet, or family history, join our study and help investigate the safety and tolerability of a potential new treatment for high blood pressure.
Eligibility
- Aged 18 to 65 years
- History of mild to moderate high blood pressure (hypertension)
- BMI between 18 and 35 kg/m2
Location
- Adelaide - SA
- Perth - WA
Duration
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21 site visits within approximately 57 weeks
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
Be among the first to access potential new research treatments before they are widely available.
Expert medical monitoring
Receive top-tier medical care and monitoring from experienced healthcare professionals.
Contribution to medical research
Help investigate a potential new treatment that could improve the lives of people with high blood pressure.
Register your interest now
or scroll down to read more about this study
About this study
01
Who can take part in this study?
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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.
- Able to attend clinical study visits as required
Additional criteria apply and will be provided upon registration and pre-screening.
02
Who is unable to take part in this study?
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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. If you’re still unsure about your suitability, no worries! Feel free to register your interest, and our Patient Experience team will contact you for a personalised discussion.
03
What does the study involve for participants?
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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.
Participation in this research is voluntary, and you may withdraw from the study at any time.
04
What is the purpose of this study?
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The purpose of this study is to investigate if a single *subcutaneous dose of ADX-850, a potential new drug for the treatment of high blood pressure, is safe and well-tolerated in people with high blood pressure. Researchers also want to explore how the body uses and is affected by ADX-850, and whether it generates an immune response to the components of ADX-850. As such, this research will help understand if ADX-850 could be a more effective treatment for high blood pressure in the future.
*Subcutaneous means the injection will be given into the fatty tissue just under the skin
05
What is hypertension (high blood pressure)?
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Hypertension, or high blood pressure, is when the force of blood pushing against your artery walls is consistently too high. According to Harvard Medical School (1), a diagnosis of hypertension can be made when a person has a mean sitting systolic blood pressure between 130 and 139 mmHg from at least two readings on at least two different occasions. Affecting more than 1 in every 3 Australians over the age of 18 (2), high blood pressure is a leading risk factor for heart disease, stroke, and kidney problems.
(1) Lewine, H.E. (2024, April 5). New high blood pressure guidelines: Think your blood pressure is fine? Think again. Harvard Health Publishing: Harvard Medical School. Retrieved from: https://www.health.harvard.edu/blog/new-high-blood-pressure-guidelines-2017111712756
(2) Healthdirect. (n.d). High blood pressure (hypertension). Retrieved July 9, 2024, from https://www.healthdirect.gov.au/high-blood-pressure-hypertension
06
What causes hypertension (high blood pressure)?
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Hypertension may be caused by various factors including:
- Age - Blood pressure tends to rise as you get older.
- A family history of high blood pressure.
- Race/Ethnicity - For instance, people of African, South Asian, or Hispanic origin have higher rates of hypertension.
- Physical inactivity, high-sodium diet, and being overweight/obese.
- Stress.
- Smoking, vaping, and excessive alcohol consumption.
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.
07
Why is this study important?
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This study is exploring a new approach to treating high blood pressure. The potential new treatment, ADX-850, works by temporarily stopping the body from making too much of a protein called angiotensinogen (AGT), which plays a key role in regulating blood pressure. This approach may be more effective than current treatments because it targets the root cause of high blood pressure more precisely, potentially leading to fewer side effects and less frequent dosing. As such, the results from this study could make it easier for patients to stick to their treatment plan, which is crucial for managing chronic conditions like hypertension and improving overall health.
08
Who is sponsoring this study?
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This study is being sponsored in Australia 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.
09
Where is my nearest study site?
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Here is a list of the sites who are conducting this study:
South Australia:
- CMAX - Adelaide
Western Australia:
- Linear Research - Perth
10
What if I have other questions about the study?
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This is a double-blind study, which means neither you nor the study doctor will know whether you receive the investigational treatment or a placebo. A placebo resembles the investigational treatment but does not contain any active ingredients. Researchers use a placebo to determine if an investigational treatment is safer than not taking anything at all. Eligible participants will have a 75% (three in four) chance of receiving the investigational treatment.
If you want to refer back to the specific details for this study, you can always visit the study information page in our Evrima Help Centre here
This study has been approved by an independent Human Research Ethics Committee
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