A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety

  • days left to enroll
  • participants needed
  • sponsor
    Idorsia Pharmaceuticals Ltd.
Updated on 4 November 2020
antihypertensive drugs


The purpose of the study is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to other anti-hypertensive drugs of patients with difficult to control (resistant) high blood pressure (hypertension), and to show that blood pressure reduction is kept for long period of time.

Treatment Placebo, Aprocitentan 12.5 mg, Aprocitentan 25 mg
Clinical Study IdentifierNCT03541174
SponsorIdorsia Pharmaceuticals Ltd.
Last Modified on4 November 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Resistant Hypertension?
Screening period
Signed and dated ICF prior to any study-mandated procedure
Male and female subjects; 18 years (or year of country specific majority) or older
Historical documentation in the subject's medical records on uncontrolled BP despite at least 3 background antihypertensive medications within 1 year before screening visit
Treated with at least 3 antihypertensive therapies of different pharmacological classes for at least 4 weeks before the screening visit (Visit 1)
Mean SiSBP 140 mmHg measured by AOBPM
Women of childbearing potential are eligible only if the following applies
Negative pregnancy test at screening and at baseline (i.e., before randomization)
Agreement to undertake pregnancy tests during the study and up to 30 days after randomized study treatment discontinuation
Agreement to use methods of birth control from Screening up to at least 30 days after randomized study treatment discontinuation
Run-in period (RI)
Switched to the standardized background antihypertensive therapy at least 4 weeks before the first RI visit
Mean trough SiSBP 140 mmHg as measured by AOBPM
Randomization period
Stable dose of the standardized background antihypertensive therapy for at least 1 week before the end of the RI period
Mean trough SiSBP 140 mmHg measured by AOBPM

Exclusion Criteria

Apparent/pseudo RHT due to white coat effect, medical inertia, poor therapeutic adherence, or secondary causes of hypertension (except sleep apnea)
Confirmed severe hypertension (grade 3) defined as SiSBP180 mmHg and/or SiDBP110 mmHg as measured by AOBPM at two different timepoints
Pregnant or lactating subjects
Clinically significant unstable cardiac disease at screening or in the past in the opinion of the investigator (exclusion of participants with significant or potential unstable cardiac disease)
Severe renal insufficiency
Any known factor, disease or clinically relevant medical or surgical conditions that, in the opinion of the investigator, might put the subject at risk, interfere with treatment compliance, study conduct or interpretation of the results
Treatment with any medication which may affect BP and/or treatment with high dose of loop diuretics (i.e., furosemide greater than 80 mg/day, or equivalent dosage of other loop diuretics)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Phone Email

Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer


user name

Annotated by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in .

No made yet