Resistant Hypertension (RHT) Clinical Trial in Valencia
NCT03541174
| Phase 3
| Interventional
Compensation of $80 per performed visit will be paid to you for time spent EXCEPT for visits 4, 6, 11 and 13 which will be $160.
This study has recruited 730 Participants
Resistant hypertension is defined as hypertension that is poorly responsive to treatment and requires the use of multiple medications to achieve acceptable blood pressure ranges. This study compares the effect of Aprocitentan, a new drug, against existing treatment in lowering blood pressure for individuals who have resistant hypertension.
Why should I participate?
You will receive study related treatment at no cost, as well as compensation for your time and travel. The results of this clinical trial could lead to new treatments that will help treat individuals impacted by RHT.
What's involved?
After a patient applies to the study, they will be contacted to schedule an appointment for their screening visit. The first screening visit will take place between 4 to 12 weeks from the time of application. During the treatment period, there will be 12 study visits over approximately 1 year.
Who can participate?
If you are 18 years or older, experiencing difficult to control blood pressure, and are being treated with three different blood pressure medications you may qualify for this study.
Details for the study
Brief Title
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
Official Title
Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)
Brief Summary
The purpose of the study is to show the blood pressure lowering effect of aprocitentan, a new
<br /> drug, when added to other anti-hypertensive drugs of patients with difficult to control
<br /> (resistant) high blood pressure (hypertension), and to show that blood pressure reduction is
<br /> kept for long period of time.
Treatments and/or Procedures
Aprocitentan 12 5 mg
Tablet, oral use
Placebo
Matching placebo tablet
Aprocitentan 25 mg
Tablet, oral use
Study 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 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 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 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).