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
PRECISION
Multi-center, Blinded, Randomized, Parallel-group, Phase 3 Study With Aprocitentan in Subjects With Resistant Hypertension (RHT)
2 other identifiers
interventional
730
20 countries
159
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2018
Typical duration for phase_3
159 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2018
CompletedFirst Posted
Study publicly available on registry
May 30, 2018
CompletedStudy Start
First participant enrolled
June 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2022
CompletedResults Posted
Study results publicly available
March 21, 2023
CompletedMarch 21, 2023
March 1, 2023
2.9 years
May 17, 2018
November 8, 2022
March 16, 2023
Conditions
Outcome Measures
Primary Outcomes (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.
Pre-dose Day 1 (Part 1 double-blind randomized baseline) up to Week 4 (End of double-blind randomized part 1)
Secondary Outcomes (5)
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
Pre-dose Week 36 (Part 3 double-blind-withdrawal baseline) up to Week 40
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
Pre-dose Day 1 (Part 1 double-blind randomized baseline) up to Week 4 (End of double-blind randomized part 1)
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
Pre-dose Day 1 (Part 1 double-blind randomized baseline) and Week 4 (End of double-blind randomized part 1)
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
Pre-dose Week 36 (Part 3 double-blind-withdrawal baseline) up to Week 40
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
From Week 36 (Part 3 double-blind-withdrawal baseline) and Week 40
Study Arms (6)
Aprocitentan 25 mg in Part 1 (double-blind)
EXPERIMENTALParticipants will receive aprocitentan 25 mg, orally, once daily in the morning for 4 weeks.
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.
Placebo in Part 1 (double-blind)
PLACEBO COMPARATORParticipants will receive placebo (matching aprocitentan), orally, once daily in the morning for 4 weeks.
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.
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.
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.
Interventions
Tablet, oral use
Tablet, oral use
Matching placebo tablet
Eligibility Criteria
You may qualify if:
- 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;
- +1 more criteria
You may not qualify if:
- 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;
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Idorsia Pharmaceuticals Ltd.lead
- Janssen Biotech, Inc.collaborator
Study Sites (159)
Advanced Cardiovascular, LLC
Alexander City, Alabama, 35010, United States
Chrishard Medical Group
Inglewood, California, 90301, United States
Clinical Trials Research
Lincoln, California, 95648, United States
Academic Medical Research Institute Inc
Los Angeles, California, 90022, United States
Amicis Research Center
Northridge, California, 91324, United States
California Kidney Specialists
San Dimas, California, 91773, United States
Bay Area Cardiology Associates, P.A.
Brandon, Florida, 33511, United States
Century Clinical Research, Inc
Daytona Beach, Florida, 32117, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Canvas Clinical Research, LLC
Lake Worth, Florida, 33467, United States
East Coast Institute for Research
Saint Augustine, Florida, 32086, United States
Premier Medical Associates
The Villages, Florida, 32159, United States
SIU School of Medicine Center for Clinical Research
Springfield, Illinois, 62702, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260, United States
Cardiovascular Research of Northwest Indiana, L.L.C.
Munster, Indiana, 46231, United States
Reid Physician Associates
Richmond, Indiana, 47374, United States
Grace Research, LLC
Bossier City, Louisiana, 71111, United States
MedStar Health Research Institute
Hyattsville, Maryland, 20782, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, 64111, United States
Hypertension and Nephrology Association PA
Eatontown, New Jersey, 07724, United States
Renal Medicine Associates
Albuquerque, New Mexico, 87109, United States
Albany Medical College
Albany, New York, 12206, United States
Scott Research Inc
Laurelton, New York, 11413, United States
Great Lakes Medical Research LLC
Westfield, New York, 14787, United States
Metrolina Internal Medicine/Internal Medicine Research
Charlotte, North Carolina, 28207, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Physician's East Endocrinology
Greenville, North Carolina, 27834, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
University Hospitals Cleveland Medical Center - Neurological Institute
Cleveland, Ohio, 44106, United States
Willamette Valley Clinical Studies
Eugene, Oregon, 97404, United States
TLM Medical Services LLC
Columbia, South Carolina, 29204, United States
DeGarmo Institute of Medical Research
Greer, South Carolina, 29650, United States
Stern Cardiovascular Foundation, Inc
Germantown, Tennessee, 38138, United States
LifeDOC Research PLLC
Memphis, Tennessee, 38119, United States
Amarillo Heart Clinical Research Institute, Inc.
Amarillo, Texas, 79106, United States
LinQ Research, LLC
Pearland, Texas, 77584, United States
Mercury Clinical Research
Webster, Texas, 77598, United States
St. George Kidney Care LLC dba Southern Utah Kidney and Hypertension Center
St. George, Utah, 84790, United States
Burke Internal Medicine & Research
Burke, Virginia, 22015, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Milwaukee Nephrologists, SC
Wauwatosa, Wisconsin, 53226, United States
Renal Research
Gosford, New South Wales, 2250, Australia
Westmead Hospital Department of Renal Medicine
Sydney, New South Wales, 2145, Australia
Baker Heart and Diabetes Institute
Melbourne, Victoria, 3004, Australia
Hypertension & Kidney Disease / Huma Neurotransmitter Laboratory
Melbourne, Victoria, 3004, Australia
Curtin University, Faculty of Health Sciences, School of Public Health
Bentley, Western Australia, 6102, Australia
Royal Perth Hospital Unit - The University of Western Australia
Perth, Western Australia, 6000, Australia
Hospital Erasme - Cardiology department
Brussels, 1070, Belgium
Clinique Universitaires de Saint Luc, Departement cardio-vasculaires intensives
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent Cardiologie
Ghent, 9000, Belgium
Centre Hospitalier Universitaire du Sart-Tilman
Liège, 4000, Belgium
Manna Research Inc (North Burlington)
Hamilton, Ontario, L8J 3W2, Canada
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 2C5, Canada
Stephen S. Chow Medicine Professional Corporation
Toronto, Ontario, M4C 5T2, Canada
Clinical Research Solutions Inc.
Waterloo, Ontario, N2J 3Z4, Canada
The First Affiliated Hospital of Baotou Medical College of Inner Mongolia
Baotou, 014010, China
The Third Xiangya Hospital of Central South University
Changsha, 410000, China
Guangdong General Hospital
Guangzhou, 510080, China
Zhejiang Province People's Hospital
Hangzhou, 310014, China
Hainan NO.3 Provincial people's Hospital
Sanya, 572000, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200000, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061, China
FN U Sv.Anny Brno, kardiologická klinika
Brno, 656 91, Czechia
Všeobecní fakultní nemocnice Praha
Prague, 128 08, Czechia
Thomayerova nemocnice
Prague, 140 59, Czechia
Interni oddeleni, Nefrologie
Prague, 16000, Czechia
Kardio Václavík s.r.o
Přerov, 750 02, Czechia
University of Oulu, Medical Research Center
Oulu, 90220, Finland
TAYS RDI center (Tampere University Hospital,Specialist Internal Medicine, Rare Diseases)
Tampere, 33520, Finland
Turku University Central Hospital - Turun yliopistollinen keskussairaala Sisätautien klinikka
Turku, 20520, Finland
CHU Grenoble - Alpes
Grenoble, 38043, France
Hôpital de la Croix-Rousse - Rhône
Lyon, 69317, France
Hôpital Européen Georges Pompidou- Centre d' Investigation Clinique
Paris, 75015, France
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, 83100, France
Jewish Hospital Berlin
Berlin, 13347, Germany
Universitätsklinikum Düsseldorf Klinik für Nephrologie
Düsseldorf, 40225, Germany
Universitätsklinikum Erlangen Klinische Forschungsstation (CRC)
Erlangen, 91054, Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, 66421, Germany
Herzzentrum Leipzig Universitätsklinik für Kardiologie
Leipzig, 04289, Germany
Universitätsklinikum Nürnberg Süd
Nuremberg, 90471, Germany
General Hospital of Athens, Ippokrateio
Athens, 11527, Greece
General Hospital of Athens Georgios Gennimatas
Athens, 15669, Greece
Asklepeion General Hospital
Athens, 16673, Greece
General Hospital Konstantopouleio-Patision
Nea Ionia, 14233, Greece
DRC Gyógyszervizsgáló Központ Kft.
Balatonfüred, 8230, Hungary
Gottsegen György Országos Kardiológiai Intézet
Budapest, 1096, Hungary
Debreceni Egyetem - Klinikai Központ
Debrecen, 4032, Hungary
Markusovszky Egyetemi Oktatókórház
Szombathely, 9700, Hungary
Haemek Medical Center
Afula, 1834111, Israel
Barzilai Medical Center, Cardiovascular Institute
Ashkelon, 7830604, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Galilee Medical Center
Nahariya, 2210001, Israel
Sheba Medical Center
Tel Litwinsky, 5265601, Israel
University Brescia Department Clinical and Experimental Science
Brescia, 25121, Italy
Ospedale San Gerardo, Clinica Medica
Monza, 20835, Italy
Azienda Ospedaliero Universitaria Pisana - Department Clinical and Experimental Medicine
Pisa, 56126, Italy
Azienda Ospedaliera S. Andrea di Roma - Division of Cardiology and of Cardiothoracic and Vascular Science Department -
Roma, 00189, Italy
SCU Medicina Interna e Centro Ipertensione arteriosa. Dipartimento di Scienze Mediche Università di Torino, Aou Citta' Salute E Scienza Torino
Torino, 10126, Italy
JSC "InMedica"
Kaunas, LT-50177, Lithuania
Clinic of Cardiology and Rehabilitation
Klaipėda, LT-91131, Lithuania
Academic Medical Center Amsterdam
Amsterdam, 1105 AZ, Netherlands
Zuyderland Medical Center
Geleen, 6162 BG, Netherlands
Maastricht University Medical Center, Dept. of Medicine
Maastricht, 6229 HX, Netherlands
Radboud University Medical Center
Nijmegen, 6500 HB, Netherlands
Uniwersyteckie Centrum Kliniczne Centrum Kardiologii
Gdansk, 80-214, Poland
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, 40-027, Poland
Diamond Clinic
Krakow, 31-559, Poland
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz, 92-213, Poland
KO-MED. CentraKliniczne Sp. Z o.o. Ośrodek Badań Klinicznych w Lublinie II
Lublin, 20-362, Poland
ETG Lublin
Lublin, 20-412, Poland
Etyka Ośrodek Badań Klinicznych
Olsztyn, 10-117, Poland
KO-MED. Centra Kliniczne Sp. Z o.o. Ośrodek Badań Klinicznych w Puławach
Puławy, 24-100, Poland
ETG Skierniewice
Skierniewice, 96-100, Poland
Medycyna Kliniczna
Warsaw, 00-874, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Warsaw, 02-097, Poland
ETG Warszawa
Warsaw, 02-777, Poland
Klinika Wad Wrodzonych Serca Instytut Kardiologii im. Kardynala Wyszynskiego
Warsaw, 04-628, Poland
Samodzielny Publiczny Szpital Wojewódzki im. Papieża Jana Pawła II w Zamościu
Zamość, 22-400, Poland
ETG Zgierz
Zgierz, 95-100, Poland
State Budgetary Healthcare Institution of Arkhangelsk Region "First City Clinical Hospital n.a. E.E. Volosevich"
Arkhangelsk, 163001, Russia
Federal State Autonomous Institution of Higher Education "Kazan (Volga Region) Federal University"
Kazan', 420043, Russia
Federal State Budget Scientific Institution "Scientific Research Institute for Complex Issues of Cardiovascular Diseases"
Kemerovo, 650002, Russia
Scientific Research Institute - Regional Clinical Hospital №1
Krasnodar, 350086, Russia
National Medical Research Center for Preventive Medicine
Moscow, 101990, Russia
State budget healthcare institution of Novosibirsk region "City clinical hospital #34"
Novosibirsk, 630054, Russia
Federal State Budget Scientific Institution "Federal Research Center Institute of Cytology and Genetics of Siberian Department of Russian Academy of Sciences"
Novosibirsk, 630089, 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, 194044, 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, 197341, Russia
Federal State Budget Institution National Medical Research Center n.a. V.A. Almazov of the Ministry of Healthcare of the Russia
Saint Petersburg, 197341, Russia
State Healthcare Institution "Regional Clinical Cardiology Dispensary"
Saratov, 410028, 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, 410054, Russia
State Budgetary Educational Institution of Higher Professional Education Smolensk State Medical Academy
Smolensk, 214018, Russia
Federal State Budget Scientific Institution "Tomsk National Research Medical Center of the Russian Academy of Sciences"
Tomsk, 634012, Russia
Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science
Tyumen, 625026, Russia
Hospital del Mar
Barcelona, 08003, Spain
Fundació Puigvert
Barcelona, 08025, Spain
Hospital Vall d'Hebron de Barcelona
Barcelona, 08035, Spain
Hospital Universitari de Bellvitge
Barcelona, 08907, Spain
Hospital Virgen de las Nieves - Internal Medicine Department
Granada, 18014, Spain
Hospital Clinico San Carlos - Istituto de Investigacion Sanitaria San Carlos (IdISSC)
Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Virgen del Rocio Departamento de Medicina Interna
Seville, 41013, Spain
Hospital Clínic Universitari de València
Valencia, 46010, Spain
Hypertension Clinic, Internal Medicine, Hospital Clinico, University of Valencia, Valencia
Valencia, 46010, Spain
State Institution "L.T. Malaya Therapy National Institute of the NAMS of Ukraine"
Kharkiv, 61039, Ukraine
Municipal non-profit enterprise "Clinical Hospital # 8"of Kharkiv City Council
Kharkiv, 61176, Ukraine
Kyiv City Clinical Hospital # 1
Kyiv, 02091, Ukraine
Kyiv Municipal Clinical Emergency Hospital
Kyiv, 02116, Ukraine
State Institution "National Scientific Center "M.D. Strazhesko Institute of Cardiology" of the National Academy of Medical Sciences of Ukraine"
Kyiv, 03680, Ukraine
State Institution "D.F. Chebotarev Institute of Gerontology, National Academy of Medical Science of Ukraine"
Kyiv, 04114, Ukraine
State Institution "Institute of Gerontology named after D.F. Chebotarev of National Academy of Medical Sciences of Ukraine"
Kyiv, 04114, Ukraine
Volyn Regional Center for Cardiovascular Pathology, Rehabilitation Department
Lutsk, 43024, Ukraine
Danylo Halytsky Lviv National Medical University
Lviv, 79013, Ukraine
Communal Non-profit Enterprise "Vinnytsya regional Clinical Hospital named after. N.I. Pirogov Vinnytsia Regional Council"/ National Pirogov Memorial Medical University, Vinnytsya
Vinnytsia, 21028, Ukraine
O.F. Herbachevsky Zhytomyr Regional Clinical Hospital, Cardiology department
Zhytomyr, 10002, Ukraine
Aberdeen Royal Infirmary, Clinical Pharmacology Unit
Aberdeen, AB24 2ZN, United Kingdom
Clinical Research Centre The University of Edinburgh Centre for Cardiovascular Science
Edinburgh, EH4 2XU, United Kingdom
Queen Mary University of London
London, EC1M 6BQ, United Kingdom
Related Publications (7)
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.
PMID: 22595447BACKGROUNDPickering 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.
PMID: 15699287BACKGROUNDDanaietash 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.
PMID: 35686330RESULTRossignol P, Clozel M, Dreier RF, Flack JM, Flamion B, Mann J, Narkiewicz K, Sassi-Sayadi M, Wang JG, Weber M, Schlaich M. Aprocitentan in Patients With Chronic Kidney Disease and Resistant Hypertension. Hypertension. 2025 Dec 9. doi: 10.1161/HYPERTENSIONAHA.125.25563. Online ahead of print.
PMID: 41363010DERIVEDFlack 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.
PMID: 39840441DERIVEDXu 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.
PMID: 37742911DERIVEDSchlaich 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.
PMID: 36356632DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Clinical Trial Disclosure Desk
- Organization
- Idorsia Pharmaceuticals Ltd
Study Officials
- STUDY DIRECTOR
Clinical Trials
Idorsia Pharmaceuticals Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2018
First Posted
May 30, 2018
Study Start
June 18, 2018
Primary Completion
May 14, 2021
Study Completion
April 25, 2022
Last Updated
March 21, 2023
Results First Posted
March 21, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share