AzTrials
AzTrials

Resistant HypertensionPhase 3PRECISIONNCT03541174

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

A Phase 3 study testing Aprocitentan 12.5 mg and Aprocitentan 25 mg in people with Resistant Hypertension, run by Idorsia Pharmaceuticals Ltd. at 159 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Resistant Hypertension
What is being tested?
Aprocitentan 12.5 mg and Aprocitentan 25 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
730 participants
Where
159 sitesin 20 countries
Study dates
18 Jun 2018to 25 Apr 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • 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.

Who cannot join

  • 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).

Trial locations and contacts

159 sites in 20 countries.

159 sites in 20 countries

United States41 sites

  • Albany Medical College

    Albany, New York, 12206

  • Renal Medicine Associates

    Albuquerque, New Mexico, 87109

  • Advanced Cardiovascular, LLC

    Alexander City, Alabama, 35010

  • Amarillo Heart Clinical Research Institute, Inc.

    Amarillo, Texas, 79106

  • Grace Research, LLC

    Bossier City, Louisiana, 71111

  • Bay Area Cardiology Associates, P.A.

    Brandon, Florida, 33511

  • Burke Internal Medicine & Research

    Burke, Virginia, 22015

  • Metrolina Internal Medicine/Internal Medicine Research

    Charlotte, North Carolina, 28207

  • University Hospitals Cleveland Medical Center - Neurological Institute

    Cleveland, Ohio, 44106

  • TLM Medical Services LLC

    Columbia, South Carolina, 29204

  • Century Clinical Research, Inc

    Daytona Beach, Florida, 32117

  • Hypertension and Nephrology Association PA

    Eatontown, New Jersey, 07724

  • Willamette Valley Clinical Studies

    Eugene, Oregon, 97404

  • Stern Cardiovascular Foundation, Inc

    Germantown, Tennessee, 38138

  • East Carolina University

    Greenville, North Carolina, 27834

  • Physician's East Endocrinology

    Greenville, North Carolina, 27834

  • DeGarmo Institute of Medical Research

    Greer, South Carolina, 29650

  • MedStar Health Research Institute

    Hyattsville, Maryland, 20782

  • Midwest Institute for Clinical Research

    Indianapolis, Indiana, 46260

  • Chrishard Medical Group

    Inglewood, California, 90301

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • Clinical Research Consultants, LLC

    Kansas City, Missouri, 64111

  • Canvas Clinical Research, LLC

    Lake Worth, Florida, 33467

  • Scott Research Inc

    Laurelton, New York, 11413

  • Clinical Trials Research

    Lincoln, California, 95648

  • Academic Medical Research Institute Inc

    Los Angeles, California, 90022

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • LifeDOC Research PLLC

    Memphis, Tennessee, 38119

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Cardiovascular Research of Northwest Indiana, L.L.C.

    Munster, Indiana, 46231

  • Amicis Research Center

    Northridge, California, 91324

  • LinQ Research, LLC

    Pearland, Texas, 77584

  • Reid Physician Associates

    Richmond, Indiana, 47374

  • East Coast Institute for Research

    Saint Augustine, Florida, 32086

  • California Kidney Specialists

    San Dimas, California, 91773

  • SIU School of Medicine Center for Clinical Research

    Springfield, Illinois, 62702

  • St. George Kidney Care LLC dba Southern Utah Kidney and Hypertension Center

    St. George, Utah, 84790

  • Premier Medical Associates

    The Villages, Florida, 32159

  • Milwaukee Nephrologists, SC

    Wauwatosa, Wisconsin, 53226

  • Mercury Clinical Research

    Webster, Texas, 77598

  • Great Lakes Medical Research LLC

    Westfield, New York, 14787

Other trials in United States

Poland15 sites

  • Uniwersyteckie Centrum Kliniczne Centrum Kardiologii

    Gdansk, 80-214

  • Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Śląskiego Uniwersytetu Medycznego w Katowicach

    Katowice, 40-027

  • Diamond Clinic

    Krakow, 31-559

  • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

    Lodz, 92-213

  • KO-MED. CentraKliniczne Sp. Z o.o. Ośrodek Badań Klinicznych w Lublinie II

    Lublin, 20-362

  • ETG Lublin

    Lublin, 20-412

  • Etyka Ośrodek Badań Klinicznych

    Olsztyn, 10-117

  • KO-MED. Centra Kliniczne Sp. Z o.o. Ośrodek Badań Klinicznych w Puławach

    Puławy, 24-100

  • ETG Skierniewice

    Skierniewice, 96-100

  • Medycyna Kliniczna

    Warsaw, 00-874

  • Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

    Warsaw, 02-097

  • ETG Warszawa

    Warsaw, 02-777

  • Klinika Wad Wrodzonych Serca Instytut Kardiologii im. Kardynala Wyszynskiego

    Warsaw, 04-628

  • Samodzielny Publiczny Szpital Wojewódzki im. Papieża Jana Pawła II w Zamościu

    Zamość, 22-400

  • ETG Zgierz

    Zgierz, 95-100

Other trials in Poland

Russia15 sites

  • State Budgetary Healthcare Institution of Arkhangelsk Region "First City Clinical Hospital n.a. E.E. Volosevich"

    Arkhangelsk, 163001

  • Federal State Autonomous Institution of Higher Education "Kazan (Volga Region) Federal University"

    Kazan', 420043

  • Federal State Budget Scientific Institution "Scientific Research Institute for Complex Issues of Cardiovascular Diseases"

    Kemerovo, 650002

  • Scientific Research Institute - Regional Clinical Hospital №1

    Krasnodar, 350086

  • National Medical Research Center for Preventive Medicine

    Moscow, 101990

  • State budget healthcare institution of Novosibirsk region "City clinical hospital #34"

    Novosibirsk, 630054

  • Federal State Budget Scientific Institution "Federal Research Center Institute of Cytology and Genetics of Siberian Department of Russian Academy of Sciences"

    Novosibirsk, 630089

  • Federal State Military Educational Institution of Higher Professional Education, Military Medical Academy named for S. M. Kirov of the Ministry of Defense of the Russian Federation

    Saint Petersburg, 194044

  • Federal State Budget Institution "National Medical Research Center n.a. V.A. Almazov" of the Ministry of healthcare of the Russian Federation

    Saint Petersburg, 197341

  • Federal State Budget Institution National Medical Research Center n.a. V.A. Almazov of the Ministry of Healthcare of the Russia

    Saint Petersburg, 197341

  • State Healthcare Institution "Regional Clinical Cardiology Dispensary"

    Saratov, 410028

  • Federal State Budget Educational Institution of Higher Education "Saratov State Medical University n.a. V.I. Razumovskiy" of the Ministry of Healthcare of the Russian Federation

    Saratov, 410054

  • State Budgetary Educational Institution of Higher Professional Education Smolensk State Medical Academy

    Smolensk, 214018

  • Federal State Budget Scientific Institution "Tomsk National Research Medical Center of the Russian Academy of Sciences"

    Tomsk, 634012

  • Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science

    Tyumen, 625026

Other trials in Russia

Ukraine11 sites

  • State Institution "L.T. Malaya Therapy National Institute of the NAMS of Ukraine"

    Kharkiv, 61039

  • Municipal non-profit enterprise "Clinical Hospital # 8"of Kharkiv City Council

    Kharkiv, 61176

  • Kyiv City Clinical Hospital # 1

    Kyiv, 02091

  • Kyiv Municipal Clinical Emergency Hospital

    Kyiv, 02116

  • State Institution "National Scientific Center "M.D. Strazhesko Institute of Cardiology" of the National Academy of Medical Sciences of Ukraine"

    Kyiv, 03680

  • State Institution "D.F. Chebotarev Institute of Gerontology, National Academy of Medical Science of Ukraine"

    Kyiv, 04114

  • State Institution "Institute of Gerontology named after D.F. Chebotarev of National Academy of Medical Sciences of Ukraine"

    Kyiv, 04114

  • Volyn Regional Center for Cardiovascular Pathology, Rehabilitation Department

    Lutsk, 43024

  • Danylo Halytsky Lviv National Medical University

    Lviv, 79013

  • Communal Non-profit Enterprise "Vinnytsya regional Clinical Hospital named after. N.I. Pirogov Vinnytsia Regional Council"/ National Pirogov Memorial Medical University, Vinnytsya

    Vinnytsia, 21028

  • O.F. Herbachevsky Zhytomyr Regional Clinical Hospital, Cardiology department

    Zhytomyr, 10002

Other trials in Ukraine

Spain10 sites

  • Hospital del Mar

    Barcelona, 08003

  • Fundació Puigvert

    Barcelona, 08025

  • Hospital Vall d'Hebron de Barcelona

    Barcelona, 08035

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

  • Hospital Virgen de las Nieves - Internal Medicine Department

    Granada, 18014

  • Hospital Clinico San Carlos - Istituto de Investigacion Sanitaria San Carlos (IdISSC)

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Virgen del Rocio Departamento de Medicina Interna

    Seville, 41013

  • Hospital Clínic Universitari de València

    Valencia, 46010

  • Hypertension Clinic, Internal Medicine, Hospital Clinico, University of Valencia, Valencia

    Valencia, 46010

Other trials in Spain

China7 sites

  • The First Affiliated Hospital of Baotou Medical College of Inner Mongolia

    Baotou, 014010

  • The Third Xiangya Hospital of Central South University

    Changsha, 410000

  • Guangdong General Hospital

    Guangzhou, 510080

  • Zhejiang Province People's Hospital

    Hangzhou, 310014

  • Hainan NO.3 Provincial people's Hospital

    Sanya, 572000

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200000

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710061

Other trials in China

Australia6 sites

  • Curtin University, Faculty of Health Sciences, School of Public Health

    Bentley, Western Australia, 6102

  • Renal Research

    Gosford, New South Wales, 2250

  • Baker Heart and Diabetes Institute

    Melbourne, Victoria, 3004

  • Hypertension & Kidney Disease / Huma Neurotransmitter Laboratory

    Melbourne, Victoria, 3004

  • Royal Perth Hospital Unit - The University of Western Australia

    Perth, Western Australia, 6000

  • Westmead Hospital Department of Renal Medicine

    Sydney, New South Wales, 2145

Other trials in Australia

Germany6 sites

  • Jewish Hospital Berlin

    Berlin, 13347

  • Universitätsklinikum Düsseldorf Klinik für Nephrologie

    Düsseldorf, 40225

  • Universitätsklinikum Erlangen Klinische Forschungsstation (CRC)

    Erlangen, 91054

  • Universitätsklinikum des Saarlandes

    Homburg/Saar, 66421

  • Herzzentrum Leipzig Universitätsklinik für Kardiologie

    Leipzig, 04289

  • Universitätsklinikum Nürnberg Süd

    Nuremberg, 90471

Other trials in Germany

Canada5 sites

  • Manna Research Inc (North Burlington)

    Hamilton, Ontario, L8J 3W2

  • London Health Sciences Centre - Victoria Hospital

    London, Ontario, N6A 5W9

  • Canadian Phase Onward Inc.

    Toronto, Ontario, M3J 2C5

  • Stephen S. Chow Medicine Professional Corporation

    Toronto, Ontario, M4C 5T2

  • Clinical Research Solutions Inc.

    Waterloo, Ontario, N2J 3Z4

Other trials in Canada

Czechia5 sites

  • FN U Sv.Anny Brno, kardiologická klinika

    Brno, 656 91

  • Všeobecní fakultní nemocnice Praha

    Prague, 128 08

  • Thomayerova nemocnice

    Prague, 140 59

  • Interni oddeleni, Nefrologie

    Prague, 16000

  • Kardio Václavík s.r.o

    Přerov, 750 02

Other trials in Czechia

Israel5 sites

  • Haemek Medical Center

    Afula, 1834111

  • Barzilai Medical Center, Cardiovascular Institute

    Ashkelon, 7830604

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Galilee Medical Center

    Nahariya, 2210001

  • Sheba Medical Center

    Tel HaShomer, 5265601

Other trials in Israel

Italy5 sites

  • University Brescia Department Clinical and Experimental Science

    Brescia, 25121

  • Ospedale San Gerardo, Clinica Medica

    Monza, 20835

  • Azienda Ospedaliero Universitaria Pisana - Department Clinical and Experimental Medicine

    Pisa, 56126

  • Azienda Ospedaliera S. Andrea di Roma - Division of Cardiology and of Cardiothoracic and Vascular Science Department -

    Roma, 00189

  • SCU Medicina Interna e Centro Ipertensione arteriosa. Dipartimento di Scienze Mediche Università di Torino, Aou Citta' Salute E Scienza Torino

    Torino, 10126

Other trials in Italy

Belgium4 sites

  • Hospital Erasme - Cardiology department

    Brussels, 1070

  • Clinique Universitaires de Saint Luc, Departement cardio-vasculaires intensives

    Brussels, 1200

  • Universitair Ziekenhuis Gent Cardiologie

    Ghent, 9000

  • Centre Hospitalier Universitaire du Sart-Tilman

    Liège, 4000

Other trials in Belgium

France4 sites

  • CHU Grenoble - Alpes

    Grenoble, 38043

  • Hôpital de la Croix-Rousse - Rhône

    Lyon, 69317

  • Hôpital Européen Georges Pompidou- Centre d' Investigation Clinique

    Paris, 75015

  • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

    Toulon, 83100

Other trials in France

Greece4 sites

  • General Hospital of Athens, Ippokrateio

    Athens, 11527

  • General Hospital of Athens Georgios Gennimatas

    Athens, 15669

  • Asklepeion General Hospital

    Athens, 16673

  • General Hospital Konstantopouleio-Patision

    Nea Ionia, 14233

Other trials in Greece

Hungary4 sites

  • DRC Gyógyszervizsgáló Központ Kft.

    Balatonfüred, 8230

  • Gottsegen György Országos Kardiológiai Intézet

    Budapest, 1096

  • Debreceni Egyetem - Klinikai Központ

    Debrecen, 4032

  • Markusovszky Egyetemi Oktatókórház

    Szombathely, 9700

Other trials in Hungary

Netherlands4 sites

  • Academic Medical Center Amsterdam

    Amsterdam, 1105 AZ

  • Zuyderland Medical Center

    Geleen, 6162 BG

  • Maastricht University Medical Center, Dept. of Medicine

    Maastricht, 6229 HX

  • Radboud University Medical Center

    Nijmegen, 6500 HB

Other trials in Netherlands

Finland3 sites

  • University of Oulu, Medical Research Center

    Oulu, 90220

  • TAYS RDI center (Tampere University Hospital,Specialist Internal Medicine, Rare Diseases)

    Tampere, 33520

  • Turku University Central Hospital - Turun yliopistollinen keskussairaala Sisätautien klinikka

    Turku, 20520

Other trials in Finland

United Kingdom3 sites

  • Aberdeen Royal Infirmary, Clinical Pharmacology Unit

    Aberdeen, AB24 2ZN

  • Clinical Research Centre The University of Edinburgh Centre for Cardiovascular Science

    Edinburgh, EH4 2XU

  • Queen Mary University of London

    London, EC1M 6BQ

Other trials in United Kingdom

Lithuania2 sites

  • JSC "InMedica"

    Kaunas, LT-50177

  • Clinic of Cardiology and Rehabilitation

    Klaipėda, LT-91131

Other trials in Lithuania

About this study

Official title: Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)

The goal of this clinical trial 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.

Read the detailed description

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.

Being tested
Aprocitentan 12.5 mg, Aprocitentan 25 mg, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aprocitentan 12.5 mgDrug

    Also called ACT-132577

    Tablet, oral use

  • Aprocitentan 25 mgDrug

    Also called ACT-132577

    Tablet, oral use

  • PlaceboDrug

    Matching placebo tablet

Study groups in NCT03541174
Study groupRoleWhat they receive
Aprocitentan 25 mg in Part 1 (double-blind)ExperimentalParticipants will receive aprocitentan 25 mg, orally, once daily in the morning for 4 weeks.
Receives: Drug: Aprocitentan 25 mg
Aprocitentan 12.5 mg in Part 1 (double-blind)ExperimentalParticipants will receive aprocitentan 12.5 mg, orally, once daily in the morning for 4 weeks.
Receives: Drug: Aprocitentan 12.5 mg
Placebo in Part 1 (double-blind)Placebo comparatorParticipants will receive placebo (matching aprocitentan), orally, once daily in the morning for 4 weeks.
Receives: Drug: Placebo
Aprocitentan 25 mg in Part 2 (single-blind, single arm)ExperimentalAfter 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.
Receives: Drug: Aprocitentan 25 mg
Aprocitentan 25 mg in Part 3 (double-blind withdrawal)ExperimentalAfter 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.
Receives: Drug: Aprocitentan 25 mg
Placebo in Part 3 (double-blind withdrawal)Placebo comparatorAfter 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 4 of Double-blind Treatment in Mean Trough Sitting Systolic Blood Pressure (SiSBP) Measured by Automated Office Blood Pressure Measurement

    Changes from baseline to Week 4 in mean trough SiSBP were analyzed using a mixed model. Participants had their blood pressure (BP) measured at the study site using the automated oscillometric sphygmomanometer (Microlife WatchBP® Office) which was provided to each site. BP was to be measured at trough (before taking the study treatment and SBAT). The BP assessment, participant preparation (e.g., arm selection, arm position, cuff size) was standardized and followed the American Heart Association guidelines / Canadian Education Program on Hypertension. The participant was resting undisturbed, alone (unattended) in a quiet place for 5 minutes at each visit. BP was measured at each visit with the same device, which recorded five sitting blood pressure readings (one per minute, the first value was excluded from the average). A negative change indicates a decrease in SiSBP from baseline.

    Measured: Pre-dose Day 1 (Part 1 double-blind randomized baseline) up to Week 4 (End of double-blind randomized part 1)

Secondary outcomes (5)

  1. Change From Double-blind Withdrawal Baseline (Week 36) to Week 40 in Mean Trough Sitting Systolic Blood Pressure (SiSBP) Measured by Unattended Automated Office Blood Pressure Measurement

    Changes from double-blind withdrawal baseline (Week 36) to Week 40 in mean trough SiSBP were analyzed using a mixed model. Participants had their blood pressure (BP) measured at the study site using the automated oscillometric sphygmomanometer (Microlife WatchBP® Office) which was provided to each site. BP was to be measured at trough (before taking the study treatment and SBAT). The BP assessment, participant preparation (e.g., arm selection, arm position, cuff size) was standardized and followed the American Heart Association guidelines / Canadian Education Program on Hypertension. The participant was resting undisturbed, alone (unattended) in a quiet place for 5 minutes at each visit. BP was measured at each visit with the same device, which recorded five sitting blood pressure readings (one per minute, the first value was excluded from the average). A negative change indicates a decrease in SiSBP from baseline.

    Measured: Pre-dose Week 36 (Part 3 double-blind-withdrawal baseline) up to Week 40

  2. Change From Baseline to Week 4 of Double-blind Treatment in Mean Trough Sitting Diastolic Blood Pressure (SiDBP) Measured by Unattended Automated Office Blood Pressure Measurement

    Changes from baseline to Week 4 in mean trough SiDBP were analyzed using a mixed model. Participants had their blood pressure (BP) measured at the study site using the automated oscillometric sphygmomanometer (Microlife WatchBP® Office) which was provided to each site. BP was to be measured at trough (before taking the study treatment and SBAT). The BP assessment, participant preparation (e.g., arm selection, arm position, cuff size) was standardized and followed the American Heart Association guidelines / Canadian Education Program on Hypertension. BP was measured at each visit with the same device, which recorded five sitting blood pressure readings (one per minute, the first value was excluded from the average). The participant was resting undisturbed, alone (unattended) in a quiet place for 5 minutes at each visit. A negative change indicates a decrease in SiDBP from baseline.

    Measured: Pre-dose Day 1 (Part 1 double-blind randomized baseline) up to Week 4 (End of double-blind randomized part 1)

  3. Changes From Baseline to Week 4 of Double-blind Treatment in 24-hour Mean Systolic (SBP) and Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring

    ABPM devices were provided to each site by the central blood pressure laboratory. On the first day after all visit assessments were performed, the ABPM device (Mobil-O-Graph NG) was fitted to the participant. The following day (i.e., second day), the participant came back to site to have the ABPM device removed. ABPM data collected over the 24-hours was electronically transferred to the central BP laboratory. Systolic blood pressure and diastolic blood pressure were measured at predetermined times every 20 minutes from 06:00 to 21:59, and every 30 minutes from 22:00 to 05:59. For each participant and at each visit (baseline and Week 4) the 24-hour mean SBP (or DBP) was calculated from the area under the SBP (or DBP) time curve and divided by the time span. A negative change indicates a decrease in 24-hour mean systolic / diastolic blood pressure from baseline.

    Measured: Pre-dose Day 1 (Part 1 double-blind randomized baseline) and Week 4 (End of double-blind randomized part 1)

  4. Change From Double-blind Withdrawal Baseline (Week 36) to Week 40 of Double-blind-withdrawal (DB-WD) Treatment in Trough Sitting Diastolic Blood Pressure (SiDBP) Measured by Unattended Automated Office Blood Pressure

    Changes from double-blind withdrawal (Week 36) to Week 40 in mean trough SiDBP were analyzed using a mixed model. Participants had their blood pressure (BP) measured at the study site using the automated oscillometric sphygmomanometer (Microlife WatchBP® Office) which was provided to each site. BP was to be measured at trough (before taking the study treatment and SBAT). The BP assessment, participant preparation (e.g., arm selection, arm position, cuff size) was standardized and followed the American Heart Association guidelines / Canadian Education Program on Hypertension. The participant was resting undisturbed, alone (unattended) in a quiet place for 5 minutes at each visit. BP was measured at each visit with the same device, which recorded five sitting blood pressure readings (one per minute, the first value was excluded from the average). A negative change indicates a decrease in SiDBP from baseline.

    Measured: Pre-dose Week 36 (Part 3 double-blind-withdrawal baseline) up to Week 40

  5. Changes From Double-blind Withdrawal Baseline (Week 36) to Week 40 of Double-blind-withdrawal (DB-WD) Treatment in 24-hour Mean Systolic (SBP) and Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring

    ABPM devices were provided to each site by the central blood pressure laboratory. On the first day after all visit assessments were performed, the ABPM device (Mobil-O-Graph NG) was fitted to the participant. The following day (i.e., second day), the participant came back to site to have the ABPM device removed. ABPM data collected over the 24-hours was electronically transferred to the central BP laboratory. Systolic blood pressure and diastolic blood pressure were measured at predetermined times every 20 minutes from 06:00 to 21:59, and every 30 minutes from 22:00 to 05:59. For each participant and at each visit (the double-blind withdrawal baseline [Week 36] and the week 40) the 24-hour mean SBP (or DBP) was calculated from the area under the SBP (or DBP) time curve. A negative change indicates a decrease in 24-hour mean systolic / diastolic blood pressure from baseline.

    Measured: From Week 36 (Part 3 double-blind-withdrawal baseline) and Week 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2018
  2. Study start18 Jun 2018
  3. Primary completion14 May 2021
  4. Study completion25 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study with multiple periods and parts. Once eligibility is confirmed during screening and the run-in period, the individuals entered the randomized treatment period consisting of 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 withdrawal (DB-WD) re-randomized to aprocitentan 25 mg or placebo.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
730 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03541174
Sponsor's protocol ID
ID-080A301
Other IDs
2017-004393-33, 2017
Acronym
PRECISION
Status last verified
Mar 2023
First submitted
17 May 2018
Last updated
21 Mar 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Daskalopoulou SS, Khan NA, Quinn RR, Ruzicka M, McKay DW, Hackam DG, Rabkin SW, Rabi DM, Gilbert RE, Padwal RS, Dawes M, Touyz RM, Campbell TS, Cloutier L, Grover S, Honos G, Herman RJ, Schiffrin EL, Bolli P, Wilson T, Feldman RD, Lindsay MP, Hemmelgarn BR, Hill MD, Gelfer M, Burns KD, Vallee M, Prasad GV, Lebel M, McLean D, Arnold JM, Moe GW, Howlett JG, Boulanger JM, Larochelle P, Leiter LA, Jones C, Ogilvie RI, Woo V, Kaczorowski J, Trudeau L, Bacon SL, Petrella RJ, Milot A, Stone JA, Drouin D, Lamarre-Cliche M, Godwin M, Tremblay G, Hamet P, Fodor G, Carruthers SG, Pylypchuk G, Burgess E, Lewanczuk R, Dresser GK, Penner B, Hegele RA, McFarlane PA, Sharma M, Campbell NR, Reid D, Poirier L, Tobe SW; Canadian Hypertension Education Program. The 2012 Canadian hypertension education program recommendations for the management of hypertension: blood pressure measurement, diagnosis, assessment of risk, and therapy. Can J Cardiol. 2012 May;28(3):270-87. doi: 10.1016/j.cjca.2012.02.018.

    PubMed 22595447

  • Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ. Recommendations for blood pressure measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Circulation. 2005 Feb 8;111(5):697-716. doi: 10.1161/01.CIR.0000154900.76284.F6.

    PubMed 15699287

  • Danaietash P, Verweij P, Wang JG, Dresser G, Kantola I, Lawrence MK, Narkiewicz K, Schlaich M, Bellet M; PRECISION investigators. Identifying and treating resistant hypertension in PRECISION: A randomized long-term clinical trial with aprocitentan. J Clin Hypertens (Greenwich). 2022 Jul;24(7):804-813. doi: 10.1111/jch.14517. Epub 2022 Jun 9.

    PubMed 35686330

  • Valdes PO, Pickard B, Orakwue C, Ferdinand K. Aprocitentan: An oral, once-daily antihypertensive therapy for resistant hypertension in adult patients. Heart Int. 2026 Feb 10;20(1):35-39. doi: 10.17925/HI.2026.20.1.1. eCollection 2026.

    PubMed 42293060

  • Rossignol P, Clozel M, Dreier RF, Flack JM, Flamion B, Mann J, Narkiewicz K, Sassi-Sayadi M, Wang JG, Weber MA, Schlaich MP. Aprocitentan in Patients With Chronic Kidney Disease and Resistant Hypertension. Hypertension. 2026 Feb;83(2):e25563. doi: 10.1161/HYPERTENSIONAHA.125.25563. Epub 2025 Dec 9.

    PubMed 41363010

  • Flack JM, Schlaich MP, Weber MA, Sassi-Sayadi M, Narkiewicz K, Clozel M, Dreier RF, Andrawis NS, Danaietash P, Gabra N, Scott D, Wang JG, Ferdinand KC. Aprocitentan for Blood Pressure Reduction in Black Patients. Hypertension. 2025 Apr;82(4):601-610. doi: 10.1161/HYPERTENSIONAHA.124.24142. Epub 2025 Jan 22.

    PubMed 39840441

  • Xu J, Jiang X, Xu S. Aprocitentan, a dual endothelin-1 (ET-1) antagonist for treating resistant hypertension: Mechanism of action and therapeutic potential. Drug Discov Today. 2023 Nov;28(11):103788. doi: 10.1016/j.drudis.2023.103788. Epub 2023 Sep 22.

    PubMed 37742911

  • Schlaich MP, Bellet M, Weber MA, Danaietash P, Bakris GL, Flack JM, Dreier RF, Sassi-Sayadi M, Haskell LP, Narkiewicz K, Wang JG; PRECISION investigators. Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trial. Lancet. 2022 Dec 3;400(10367):1927-1937. doi: 10.1016/S0140-6736(22)02034-7. Epub 2022 Nov 7.

    PubMed 36356632

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aprocitentan 12.5 mg and Aprocitentan 25 mg in people with Resistant Hypertension, run by Idorsia Pharmaceuticals Ltd. at 159 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 159 sites in United States, Poland, Russia, Ukraine, Spain and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 4 of Double-blind Treatment in Mean Trough Sitting Systolic Blood Pressure (SiSBP) Measured by Automated Office Blood Pressure Measurement (time frame: Pre-dose Day 1 (Part 1 double-blind randomized baseline) up to Week 4 (End of double-blind randomized part 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03541174, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.

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