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
NCT ID: NCT03541174
Last Updated: 2023-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
730 participants
INTERVENTIONAL
2018-06-18
2022-04-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
TRIPLE
Study Groups
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Aprocitentan 25 mg in Part 1 (double-blind)
Participants will receive aprocitentan 25 mg, orally, once daily in the morning for 4 weeks.
Aprocitentan 25 mg
Tablet, oral use
Aprocitentan 12.5 mg in Part 1 (double-blind)
Participants will receive aprocitentan 12.5 mg, orally, once daily in the morning for 4 weeks.
Aprocitentan 12.5 mg
Tablet, oral use
Placebo in Part 1 (double-blind)
Participants will receive placebo (matching aprocitentan), orally, once daily in the morning for 4 weeks.
Placebo
Matching placebo tablet
Aprocitentan 25 mg in Part 2 (single-blind, single arm)
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.
Aprocitentan 25 mg
Tablet, oral use
Aprocitentan 25 mg in Part 3 (double-blind withdrawal)
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.
Aprocitentan 25 mg
Tablet, oral use
Placebo in Part 3 (double-blind withdrawal)
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.
Placebo
Matching placebo tablet
Interventions
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Aprocitentan 12.5 mg
Tablet, oral use
Aprocitentan 25 mg
Tablet, oral use
Placebo
Matching placebo tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Janssen Biotech, Inc.
INDUSTRY
Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Idorsia Pharmaceuticals Ltd.
Locations
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Advanced Cardiovascular, LLC
Alexander City, Alabama, United States
Chrishard Medical Group
Inglewood, California, United States
Clinical Trials Research
Lincoln, California, United States
Academic Medical Research Institute Inc
Los Angeles, California, United States
Amicis Research Center
Northridge, California, United States
California Kidney Specialists
San Dimas, California, United States
Bay Area Cardiology Associates, P.A.
Brandon, Florida, United States
Century Clinical Research, Inc
Daytona Beach, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Canvas Clinical Research, LLC
Lake Worth, Florida, United States
East Coast Institute for Research
Saint Augustine, Florida, United States
Premier Medical Associates
The Villages, Florida, United States
SIU School of Medicine Center for Clinical Research
Springfield, Illinois, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States
Cardiovascular Research of Northwest Indiana, L.L.C.
Munster, Indiana, United States
Reid Physician Associates
Richmond, Indiana, United States
Grace Research, LLC
Bossier City, Louisiana, United States
MedStar Health Research Institute
Hyattsville, Maryland, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, United States
Hypertension and Nephrology Association PA
Eatontown, New Jersey, United States
Renal Medicine Associates
Albuquerque, New Mexico, United States
Albany Medical College
Albany, New York, United States
Scott Research Inc
Laurelton, New York, United States
Great Lakes Medical Research LLC
Westfield, New York, United States
Metrolina Internal Medicine/Internal Medicine Research
Charlotte, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Physician's East Endocrinology
Greenville, North Carolina, United States
Carteret Medical Group
Morehead City, North Carolina, United States
University Hospitals Cleveland Medical Center - Neurological Institute
Cleveland, Ohio, United States
Willamette Valley Clinical Studies
Eugene, Oregon, United States
TLM Medical Services LLC
Columbia, South Carolina, United States
DeGarmo Institute of Medical Research
Greer, South Carolina, United States
Stern Cardiovascular Foundation, Inc
Germantown, Tennessee, United States
LifeDOC Research PLLC
Memphis, Tennessee, United States
Amarillo Heart Clinical Research Institute, Inc.
Amarillo, Texas, United States
LinQ Research, LLC
Pearland, Texas, United States
Mercury Clinical Research
Webster, Texas, United States
St. George Kidney Care LLC dba Southern Utah Kidney and Hypertension Center
St. George, Utah, United States
Burke Internal Medicine & Research
Burke, Virginia, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Milwaukee Nephrologists, SC
Wauwatosa, Wisconsin, United States
Renal Research
Gosford, New South Wales, Australia
Westmead Hospital Department of Renal Medicine
Sydney, New South Wales, Australia
Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia
Hypertension & Kidney Disease / Huma Neurotransmitter Laboratory
Melbourne, Victoria, Australia
Curtin University, Faculty of Health Sciences, School of Public Health
Bentley, Western Australia, Australia
Royal Perth Hospital Unit - The University of Western Australia
Perth, Western Australia, Australia
Hospital Erasme - Cardiology department
Brussels, , Belgium
Clinique Universitaires de Saint Luc, Departement cardio-vasculaires intensives
Brussels, , Belgium
Universitair Ziekenhuis Gent Cardiologie
Ghent, , Belgium
Centre Hospitalier Universitaire du Sart-Tilman
Liège, , Belgium
Manna Research Inc (North Burlington)
Hamilton, Ontario, Canada
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, Canada
Stephen S. Chow Medicine Professional Corporation
Toronto, Ontario, Canada
Clinical Research Solutions Inc.
Waterloo, Ontario, Canada
The First Affiliated Hospital of Baotou Medical College of Inner Mongolia
Baotou, , China
The Third Xiangya Hospital of Central South University
Changsha, , China
Guangdong General Hospital
Guangzhou, , China
Zhejiang Province People's Hospital
Hangzhou, , China
Hainan NO.3 Provincial people's Hospital
Sanya, , China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, , China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
FN U Sv.Anny Brno, kardiologická klinika
Brno, , Czechia
Všeobecní fakultní nemocnice Praha
Prague, , Czechia
Thomayerova nemocnice
Prague, , Czechia
Interni oddeleni, Nefrologie
Prague, , Czechia
Kardio Václavík s.r.o
Přerov, , Czechia
University of Oulu, Medical Research Center
Oulu, , Finland
TAYS RDI center (Tampere University Hospital,Specialist Internal Medicine, Rare Diseases)
Tampere, , Finland
Turku University Central Hospital - Turun yliopistollinen keskussairaala Sisätautien klinikka
Turku, , Finland
CHU Grenoble - Alpes
Grenoble, , France
Hôpital de la Croix-Rousse - Rhône
Lyon, , France
Hôpital Européen Georges Pompidou- Centre d' Investigation Clinique
Paris, , France
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, , France
Jewish Hospital Berlin
Berlin, , Germany
Universitätsklinikum Düsseldorf Klinik für Nephrologie
Düsseldorf, , Germany
Universitätsklinikum Erlangen Klinische Forschungsstation (CRC)
Erlangen, , Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, , Germany
Herzzentrum Leipzig Universitätsklinik für Kardiologie
Leipzig, , Germany
Universitätsklinikum Nürnberg Süd
Nuremberg, , Germany
General Hospital of Athens, Ippokrateio
Athens, , Greece
General Hospital of Athens Georgios Gennimatas
Athens, , Greece
Asklepeion General Hospital
Athens, , Greece
General Hospital Konstantopouleio-Patision
Nea Ionia, , Greece
DRC Gyógyszervizsgáló Központ Kft.
Balatonfüred, , Hungary
Gottsegen György Országos Kardiológiai Intézet
Budapest, , Hungary
Debreceni Egyetem - Klinikai Központ
Debrecen, , Hungary
Markusovszky Egyetemi Oktatókórház
Szombathely, , Hungary
Haemek Medical Center
Afula, , Israel
Barzilai Medical Center, Cardiovascular Institute
Ashkelon, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Galilee Medical Center
Nahariya, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
University Brescia Department Clinical and Experimental Science
Brescia, , Italy
Ospedale San Gerardo, Clinica Medica
Monza, , Italy
Azienda Ospedaliero Universitaria Pisana - Department Clinical and Experimental Medicine
Pisa, , Italy
Azienda Ospedaliera S. Andrea di Roma - Division of Cardiology and of Cardiothoracic and Vascular Science Department -
Roma, , Italy
SCU Medicina Interna e Centro Ipertensione arteriosa. Dipartimento di Scienze Mediche Università di Torino, Aou Citta' Salute E Scienza Torino
Torino, , Italy
JSC "InMedica"
Kaunas, , Lithuania
Clinic of Cardiology and Rehabilitation
Klaipėda, , Lithuania
Academic Medical Center Amsterdam
Amsterdam, , Netherlands
Zuyderland Medical Center
Geleen, , Netherlands
Maastricht University Medical Center, Dept. of Medicine
Maastricht, , Netherlands
Radboud University Medical Center
Nijmegen, , Netherlands
Uniwersyteckie Centrum Kliniczne Centrum Kardiologii
Gdansk, , Poland
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, , Poland
Diamond Clinic
Krakow, , Poland
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz, , Poland
KO-MED. CentraKliniczne Sp. Z o.o. Ośrodek Badań Klinicznych w Lublinie II
Lublin, , Poland
ETG Lublin
Lublin, , Poland
Etyka Ośrodek Badań Klinicznych
Olsztyn, , Poland
KO-MED. Centra Kliniczne Sp. Z o.o. Ośrodek Badań Klinicznych w Puławach
Puławy, , Poland
ETG Skierniewice
Skierniewice, , Poland
Medycyna Kliniczna
Warsaw, , Poland
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Warsaw, , Poland
ETG Warszawa
Warsaw, , Poland
Klinika Wad Wrodzonych Serca Instytut Kardiologii im. Kardynala Wyszynskiego
Warsaw, , Poland
Samodzielny Publiczny Szpital Wojewódzki im. Papieża Jana Pawła II w Zamościu
Zamość, , Poland
ETG Zgierz
Zgierz, , Poland
State Budgetary Healthcare Institution of Arkhangelsk Region "First City Clinical Hospital n.a. E.E. Volosevich"
Arkhangelsk, , Russia
Federal State Autonomous Institution of Higher Education "Kazan (Volga Region) Federal University"
Kazan', , Russia
Federal State Budget Scientific Institution "Scientific Research Institute for Complex Issues of Cardiovascular Diseases"
Kemerovo, , Russia
Scientific Research Institute - Regional Clinical Hospital №1
Krasnodar, , Russia
National Medical Research Center for Preventive Medicine
Moscow, , Russia
State budget healthcare institution of Novosibirsk region "City clinical hospital #34"
Novosibirsk, , Russia
Federal State Budget Scientific Institution "Federal Research Center Institute of Cytology and Genetics of Siberian Department of Russian Academy of Sciences"
Novosibirsk, , Russia
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, , Russia
Federal State Budget Institution "National Medical Research Center n.a. V.A. Almazov" of the Ministry of healthcare of the Russian Federation
Saint Petersburg, , Russia
Federal State Budget Institution National Medical Research Center n.a. V.A. Almazov of the Ministry of Healthcare of the Russia
Saint Petersburg, , Russia
State Healthcare Institution "Regional Clinical Cardiology Dispensary"
Saratov, , Russia
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, , Russia
State Budgetary Educational Institution of Higher Professional Education Smolensk State Medical Academy
Smolensk, , Russia
Federal State Budget Scientific Institution "Tomsk National Research Medical Center of the Russian Academy of Sciences"
Tomsk, , Russia
Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science
Tyumen, , Russia
Hospital del Mar
Barcelona, , Spain
Fundació Puigvert
Barcelona, , Spain
Hospital Vall d'Hebron de Barcelona
Barcelona, , Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
Hospital Virgen de las Nieves - Internal Medicine Department
Granada, , Spain
Hospital Clinico San Carlos - Istituto de Investigacion Sanitaria San Carlos (IdISSC)
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Virgen del Rocio Departamento de Medicina Interna
Seville, , Spain
Hospital Clínic Universitari de València
Valencia, , Spain
Hypertension Clinic, Internal Medicine, Hospital Clinico, University of Valencia, Valencia
Valencia, , Spain
State Institution "L.T. Malaya Therapy National Institute of the NAMS of Ukraine"
Kharkiv, , Ukraine
Municipal non-profit enterprise "Clinical Hospital # 8"of Kharkiv City Council
Kharkiv, , Ukraine
Kyiv City Clinical Hospital # 1
Kyiv, , Ukraine
Kyiv Municipal Clinical Emergency Hospital
Kyiv, , Ukraine
State Institution "National Scientific Center "M.D. Strazhesko Institute of Cardiology" of the National Academy of Medical Sciences of Ukraine"
Kyiv, , Ukraine
State Institution "D.F. Chebotarev Institute of Gerontology, National Academy of Medical Science of Ukraine"
Kyiv, , Ukraine
State Institution "Institute of Gerontology named after D.F. Chebotarev of National Academy of Medical Sciences of Ukraine"
Kyiv, , Ukraine
Volyn Regional Center for Cardiovascular Pathology, Rehabilitation Department
Lutsk, , Ukraine
Danylo Halytsky Lviv National Medical University
Lviv, , Ukraine
Communal Non-profit Enterprise "Vinnytsya regional Clinical Hospital named after. N.I. Pirogov Vinnytsia Regional Council"/ National Pirogov Memorial Medical University, Vinnytsya
Vinnytsia, , Ukraine
O.F. Herbachevsky Zhytomyr Regional Clinical Hospital, Cardiology department
Zhytomyr, , Ukraine
Aberdeen Royal Infirmary, Clinical Pharmacology Unit
Aberdeen, , United Kingdom
Clinical Research Centre The University of Edinburgh Centre for Cardiovascular Science
Edinburgh, , United Kingdom
Queen Mary University of London
London, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol: Protocol
Document Type: Study Protocol: Protocol Addendum Covid-19
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-004393-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ID-080A301
Identifier Type: -
Identifier Source: org_study_id
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