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

  • STATUS
    Recruiting
  • days left to enroll
    75
  • participants needed
    600
  • sponsor
    Idorsia Pharmaceuticals Ltd.
Updated on 4 November 2020
antihypertensive drugs

Summary

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.

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

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Eligibility

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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)
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