Could managing high blood pressure be easier?

This clinical study is exploring a potential way to manage high blood pressure (hypertension). The study is testing an investigational study drug, given as a small injection every 6 months, to see if it can reduce high blood pressure compared to the placebo (inactive medicine). If your blood pressure is hard to control, and you are on 0-2 medications you may qualify.

Taking care of high blood pressure is very important for your health. If left untreated, it may lead to major health issues such as heart attack and stroke.  

Study Overview

We are looking for adults with high blood pressure to participate in this clinical study.  
Right now, most medicines for high blood pressure need to be taken every day, and sometimes up to twice daily and that can be hard for some people to remember or keep up with.  

This study is focused on a study drug given as a small injection (shot) under the skin every 6 months to test if it may lower blood pressure. The study will also look to assess different doses of the study drug.  

It might feel hard to manage high blood pressure, but keeping blood pressure well managed helps you stay healthy.  
We are dedicated to helping research that may improve disease treatment and care. 

What is high blood pressure? 

High blood pressure is a very common condition where the force of blood in your blood vessels is too high. If blood pressure stays high for too long, it can lead to serious health problems like heart attack and stroke.

More than 1 billion people ages 30-79 have high blood pressure. Only around 21% of people have it under control. Some people may not even know they have it because there are not always signs or symptoms.¹

Tracking regular blood pressure readings with a healthcare provider or at home using a home blood pressure monitor is important so that it can be caught early and treated.

See if you qualify: Take the pre-screening questionnaire.

Blood pressure readings 

Understanding your blood pressure readings.  

Click here to find out more: Understanding Blood Pressure Readings | American Heart Association 

Normal: 
• Systolic (top number): Under 120 
• Diastolic (bottom number): Under 80 

Elevated: 
• Systolic (top number): 120-139 
• Diastolic (bottom number): 80-89 

High blood pressure (stage 1): 
• Systolic (top number): 140-159 
• Diastolic (bottom number): 90-99 

High blood pressure (stage 2): 
• Systolic (top number): Over 160 
• Diastolic (bottom number): Over 100 

High blood emergency (contact your doctor immediately!): 
• Systolic (top number): Over 180 
• Diastolic (bottom number): Over 110 

What are possible warning signs of high blood pressure? 
Sometimes people with high blood pressure don’t feel any different at all. In some cases, people with high blood pressure might feel:  

• Fatigue–tired even without much activity  
• Chest pain or pressure  
• Trouble breathing  
• Headaches  
• Nosebleeds 

¹ World Health Organization. (2021, May). Hypertension. World Health Organization.

Who can join the study?

We are looking for adults with high blood pressure to participate in this clinical study.  

If you have high blood pressure and are frustrated with the idea of taking a daily pill, this study may be an opportunity to explore another option! This trial offers a small injection (shot) once every 6 months that may lower blood pressure.  

You may qualify for this Novartis clinical study if you: 

  • Are between 18 and 75 years old  

  • Have been diagnosed with high blood pressure 

  • Are not taking high blood pressure medicine(s) OR are taking up to 2 high blood pressure medicines 

If you pre-qualify, there are other study requirements that the study team will discuss with you. 

Taking part in this study is always your choice and you can stop at taking part at any time, for any reason. 

What to expect if you join this Novartis study: 

Meet with a study doctor to see if this study is a good fit for you  

  • Complete 20 total visits over 1.5 years (mix of office and phone visits) 

  • Receive study drug  

  • In-home monitoring of your blood pressure 

  • You may be reimbursed for reasonable expenses that you may incur as a result of taking part in this study. These expenses may include parking, meals, transportation or other travel-related expenses.  

Take the pre-screening questionnaire.

What to expect when joining a high blood pressure study?


The pre-screening process 
If you are interested in joining a clinical study, the first step is to learn about the study and see if you meet the initial qualifications. All you’ll have to do is fill out the short online pre-screening questionnaire below to see if this study is a good fit for you.  

If you pass the online pre-screening questionnaire, you'll be connected to a research study site near you. The research study site will reach out to you directly. 

Take the pre-screening questionnaire.

Finding a research study site 
The study doctor and research team at the study site will provide additional information and guide you through the next steps.  

Study sites conducting the study can be found here: ClinicalTrials.gov

You do not have to join the study if you do not want to, and you can change your mind at any time. 

The screening and informed consent process 
If you meet the pre-qualifications, you’ll be invited to the research study site for an in-person visit to learn more about the study.  

At your appointment, the study doctor and research team will explain all the details about the study, including any risks and benefits for participating. They will also answer any questions you may have.  

If you are interested in joining the study after speaking with a study doctor and research team, you will be asked to sign an informed consent document, which confirms you have agreed to participate in the study and go through all the necessary study assessments, which begins with a screening process. The purpose of the screening process is to determine if you meet the study requirements. Based on all the information collected and test results, the doctor will decide if you qualify for the study. 

The study treatment period 
The study treatment period is broken up into 2 periods of 6 months each.  During Part 1 of the Study Treatment Period, you will receive either the study drug or the placebo (inactive medicine). 

If you received the placebo in Part 1, you will receive the study drug during Part 2. If you received the study drug in Part 1, you will receive either the study drug or the placebo in Part 2. 

The follow-up period 
The follow-up period will take place over the course of 6 months and involves 2 study-site visits.  

Study activities and test will vary at each visit, but may include:  

  • Health-related questions 

  • Routine physical exam 

  • Blood pressure monitoring in the office and at home 

  • Heart activity check (ECG) 

  • Blood and urine sample collection 

Frequently Asked Questions

  • Clinical research is the process of testing and developing medicines to potentially prevent, treat, or manage diseases. Before any medicine becomes FDA-approved and available, it must undergo clinical trials to ensure safety and effectiveness.

  • The goal of this study is to determine how effective the treatment is at lowering blood pressure. The study will also look to assess different doses, along with documenting the potential side effects.

  • You’ll help us learn about the study drug to see if it could potentially be an option for lowering blood pressure.

  • No. All study-related care is provided at no cost, and you do not need healthcare insurance to participate. You will not have to pay for the study drug, but your regular medications will not be paid for as part of the study.

  • Yes. Taking part in a study is always your choice. You can change your mind or stop taking part at any time, for any reason.

  • Here are some useful links to find more important information about high blood pressure:

  • All participant data will be kept confidential and used only for research purposes. We follow strict privacy and security guidelines to keep your information safe.