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

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 18-005342
    NCT ID: NCT03541174
    Sponsor Protocol Number: 080A301

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

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 including a diuretic 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 since start 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 SiSBP≥180 mmHg and/or SiDBP≥110 mmHg as measured by AOBPM at two different timepoints;
  • Pregnant or lactating subjects; 
  • Clinically significant unstable cardiac disease in the opinion of the investigator;
  • Severe renal insufficiency;
  • N-terminal pro-brain natriuretic peptide (NT-proBNP) ≥ 200 pg/mL;
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Nabeel Aslam, M.D.

Open for enrollment

Contact information:

Samantha Eilerman

(904)953-3523

Eilerman.Samantha@mayo.edu