Resistant Hypertension MedDRA version: 20.0 Level: LLT Classification code 10020783 Term: Hypertension not adequately controlled System Organ Class: 100000004866
Conditions
Interventions
Product Name: Aprocitentan
Product Code: ACT-132577
Pharmaceutical Form: Tablet
INN or Proposed INN: Aprocitentan
Current Sponsor code: ACT-132577
Other descriptive name: ACT-132577
Concentration unit
Sponsors
Idorsia Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Screening visit: 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 (end of RI period) ; 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 entry criteria: switched to the standardized; background antihypertensive therapy at least 4 weeks before the first RI visit; Mean trough SiSBP = 140 mmHg measured by AOBPM. - Randomization criteria: Stable dose of the standardized background antihypertensive therapy since the start of the RI period; Mean trough SiSBP = 140 mmHg measured by AOBPM. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
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 time points.; - 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) > or = 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the blood pressure (BP) lowering effect of aprocitentan when added to standard of care in true resistant hypertension (RHT) subjects.;Secondary Objective: - To demonstrate that the effect of aprocitentan on BP is durable when added to standard of care in true RHT subjects. - To evaluate the long-term safety and tolerability of aprocitentan in true RHT subjects during 48 weeks of treatment.;Primary end point(s): - Change from baseline to Week 4 of double-blind (DB) treatment in mean trough SiSBP measured by AOBPM.;Timepoint(s) of evaluation of this end point: From baseline to Week 4 after treatment initiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from Week 36 (i.e., start of double-blind withdrawal [DB-WD]) to Week 40 in mean trough SiSBP measured by AOBPM - Change from baseline to Week 4 of DB treatment in trough Sitting Diastolic BP (SiDBP) measured by AOBPM; - Changes from baseline to Week 4 of DB treatment in 24-h mean SBP and DBP measured by ABPM; - Change from Week 36 to Week 40 of DB-WD treatment in mean trough SiDBP measured by AOBPM; - Changes from Week 36 to Week 40 of DB-WD treatment in 24-h mean SBP and DBP measured by ABPM.;Timepoint(s) of evaluation of this end point: From baseline to week 4, or from week 36 to week 40. | — |
Countries
Australia, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Lithuania, Netherlands, Poland, Russian Federation, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactClinical Trial Disclosure Desk
Idorsia Pharmaceuticals Ltd
Outcome results
None listed