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
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.
- Resistant Hypertension
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- Stable dose of the standardized background antihypertensive therapy since start of the RI period;
- Mean trough SiSBP ≥ 140 mmHg measured by AOBPM.
- 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;
- 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.
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- SB placebo run-in/randomized with 3 parts: Part 1: double-blind (DB), randomized to aprocitentan 12.5 mg, aprocitentan 25 mg or placebo; Part 2: single blind (SB) aprocitentan 25 mg; Part 3: double-blind re-randomized (DB-WD) to aprocitentan 25 mg or placebo.
- Primary Purpose
- Triple (Participant, Care Provider, Investigator)
Aprocitentan 25 mg DB
|Part 1: Double-blind, randomized (1:1:1 ratio), parallel-group and placebo-controlled and lasts for 4 weeks. Subjects will receive aprocitentan 25 mg||
Aprocitentan 12.5 mg DB
|Part 1: Double-blind, randomized (1:1:1 ratio), parallel-group and placebo-controlled and lasts for 4 weeks. Subjects will receive aprocitentan 12.5 mg||
|Part 1: Double-blind, randomized (1:1:1 ratio), parallel-group and placebo-controlled and lasts for 4 weeks. Subjects will receive placebo||
Aprocitentan 25 mg SB
|Part 2: Single-blind and single-arm, lasts for 32 weeks. All subjects will receive aprocitentan 25 mg.||
Aprocitentan 25 mg DB-WD
|Part 3: Double-blind withdrawal. Subjects will be re-randomized to aprocitentan 25 mg||
|Part 3: Double-blind withdrawal. Subjects will be re-randomized to placebo.||
- NCT ID
- Idorsia Pharmaceuticals Ltd.
Study ContactClinical Trial Disclosure desk