A research study to find out if aprocitentan is efficacious and safe to treat difficult to control (resistant) high blood pressure (hypertension)

Phase 1

• Conditions: Resistant Hypertension; MedDRA version: 21.1Level: LLTClassification code 10020783Term: Hypertension not adequately controlledSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-004393-33-PL
• Lead Sponsor: Idorsia Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-03
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Screening criteria:
- 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., 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
for at least 1 week before Day -1 (end 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

- 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 at screening or in the
past in the opinion of the investigator, e.g. uncontrolled symptomatic
arrhythmia, atrial fibrillation, congestive heart failure NYHA stage II
with relevant mitral valve insufficiency and/or aortic stenosis,
congestive heart failure NYHA stage III or IV;
- Severe renal insufficiency;
- N-terminal pro-brain natriuretic peptide (NT-proBNP) = 500 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
- Treatment with any medication which may affect blood pressure
and/or treatment with high dose of loop diuretics (i.e., furosemide
greater than 80 mg/day, or equivalent dosage of other loop diuretics).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified