Completed

PRECISIONMulti-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)

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What is being tested

Aprocitentan 12.5 mg

+ Aprocitentan 25 mg

+ Placebo

Drug
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: June 2018
See protocol details

Summary

Principal SponsorIdorsia Pharmaceuticals Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 18, 2018

Actual date on which the first participant was enrolled.

Participation in the study will be up to 68 weeks. The study has 4 periods: 1. Screening period 2. Placebo run-in period 3. Randomized treatment period 4. Safety follow-up period The screening period lasts between 4 and 12 weeks. It starts at the screening visit with the signing of the informed consent form (ICF) and ends the day before the participant enters the run-in period. At least 4 weeks before the start of the run-in period, the background antihypertensive medication (except beta-blockers) of participants with a diagnosis of true resistant hypertension and having a mean trough sitting systolic blood pressure of equal to or greater than 140 mmHg measured by automated AOBPM will be standardized by switching to a fixed combination of a calcium channel blocker (amlodipine), an angiotensin receptor blocker (valsartan) and a diuretic (hydrochlorothiazide). In case a beta-blocker is used as one of the background antihypertensive medications or for any other indication, this can be kept, with the provision that it has been initiated and the dose kept stable for at least 4 weeks prior to the screening visit and the dose kept stable until the end-of-treatment. Following the screening period this study has a run-in period of 4 weeks. During this period, placebo will be administered in order to exclude potential placebo responders. Following the run-in period eligible participants will enter the randomized treatment period. This period lasts for 48 weeks. It starts at randomization (i.e., Day 1 of the double-blind part) and ends at the end-of-treatment visit (i.e., at the end of the double-blind withdrawal part). The randomized treatment period consists of 3 parts: Part 1 is double-blind, randomized, parallel-group and placebo-controlled and lasts 4 weeks. Part 2 is single-blind and single-arm and lasts for 32 weeks. Part 3 is a double-blind withdrawal, randomized, parallel-group and placebo-controlled and lasts for 12 weeks. End-of treatment is at Week 48 (i.e., end of the double-blind withdrawal part). The safety follow-up starts on the day after the last dose of study treatment and ends 30 to 33 days after the last dose of study treatment.

Official TitleMulti-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)
NCT03541174
Principal SponsorIdorsia Pharmaceuticals Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

730 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: Screening period: * Signed and dated informed consent form (ICF) prior to any study-mandated procedure; * Male and female participants; 18 years (or year of country specific majority) or older; * Historical documentation in the participant's medical records on uncontrolled blood pressure 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 Sitting Systolic Blood Pressure (SiSBP) greater or equal to 140 mmHg measured by Automated Office Blood Pressure Measurement (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 greater than or equal to140 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 greater than or equal to 140 mmHg measured by AOBPM. Exclusion Criteria: * Apparent/pseudo Resistant Hypertension (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 greater than or equal to 180 mmHg and/or Sitting Diastolic Blood Pressure (SiDBP) greater than or equal to 110 mmHg as measured by AOBPM at two different timepoints; * Pregnant or lactating participants; * 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 participant at risk, interfere with treatment compliance, study conduct or interpretation of the results. * Treatment with any medication which may affect blood pressure (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).

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive aprocitentan 12.5 mg, orally, once daily in the morning for 4 weeks.

Group II

Experimental
Participants will receive aprocitentan 25 mg, orally, once daily in the morning for 4 weeks.

Group III

Experimental
After 4-weeks in the double-blind randomized part (Part 1), participants will received 25 mg aprocitentan, orally, once daily in the morning for 32 weeks.

Group IV

Experimental
After 32-weeks in the single-blind, single-arm part (Part 2), participants will be re-randomized and receive aprocitentan 25 mg, orally, once daily in the morning for 12 weeks.

Group 5

Placebo
Participants will receive placebo (matching aprocitentan), orally, once daily in the morning for 4 weeks.

Group 6

Placebo
After 32-weeks in the single-blind, single-arm part (Part 2), participants will be re-randomized and receive placebo (matching aprocitentan), orally, once daily in the morning for 12 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 159 locations

Suspended

Great Lakes Medical Research LLC

Westfield, United StatesOpen Great Lakes Medical Research LLC in Google Maps
Suspended

University Hospitals Cleveland Medical Center - Neurological Institute

Cleveland, United States
Suspended

Willamette Valley Clinical Studies

Eugene, United States
Suspended

TLM Medical Services LLC

Columbia, United States
Completed159 Study Centers
PRECISION | Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT) | PatLynk