Tracleer (bosentan) / J&J, Roche 
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 114 Diseases   29 Trials   29 Trials   1255 News 
38 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Tracleer (bosentan) / J&J, Roche
ACTRN12606000289516: Pulmonary Artery Remodelling With Bosentan

Not yet recruiting
4
15
 
Actelion Phrmaceuticals Australia, Actelion Phrmaceuticals Australia
Hypertension, Pulmonary
 
 
2006-003133-33: Etude des effets d’un antagoniste non spécifique de l’endothéline (le bosentan) sur l’activité orthosympathique et le chémoréflexe.

Ongoing
4
20
Europe
Tablet, Tracleer
Hôpital Erasme
healthy subjectsobstructive sleep apnea(Bosentan is used in clinic in pulmonary hypertension)
 
 
ChiCTR-ONC-11001799: A single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease

Completed
4
50
 
Bosentan therapy
Beijing Anzhen Hospital; Beijing Anzhen Hospital, Actelion Pharmaceuticals Ltd
pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease
 
 
2006-005361-19: Evaluation of the efficacy of the dual endothelin 1 receptor antagonist Bosentan in the treatment of Pulmonary Hypertension secondary to Chronic Obstructive Pulmonary Disease and in the treatment of Pulmonary Hypertension secondary to sarcoidosis

Ongoing
4
45
Europe
tracleer, Tracleer, Tracleer
St Georges Hospital
Pulmonary Hypertension secondary to Chronic Obstructive Pulmonary Disease and secondary to SarcoidPatients devolop pulmonary hypertension for various reasons, two common causes are Chronic Obstructive Pulmonary disease and Sarcoid. Once developed it may go on to cause right heart failure and severe breathlessness and eventually death.We believe that the use of bosentan may lower the pulmonary hypertension and improve symptoms.
 
 
2005-005898-29: The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation

Ongoing
4
15
Europe
bosentan, Tracleer, Tracleer
University Hospital Birmingham
Patients with a Fontan circulation (that is they have had a Fontan operation for a functionally univentricular heart)
 
 
2008-004533-21: The role of Bosentan in fontan patients: improvement of aerobic capacity

Ongoing
4
50
Europe
Tracleer, 66215-101, Tracleer, Tracleer
ICIN
To study whether bosentan (endothelin receptor inhibitor) improves aerobic capacity (VO2max) and exercise performance in adult patients with a Fontan operation.
 
 
2009-015602-18: Diabetes and vascular complications: the role of endothelin and physical inactivity’

Ongoing
4
30
Europe
Tracleer, Tracleer-H-C-401-II-40, Tracleer, Tracleer
Actelion Pharmaceuticals
type 2 diabetes mellius
 
 
2010-020209-33: BOsentan for Mild Pulmonary vascular disease in Asd patients (the BOMPA trial): a double-blind, randomized controlled, pilot trial

Ongoing
4
20
Europe
bosentan, C02KX01, Tracleer, Tracleer
University Hospitals Leuven
Repaired (after the age of 40) atrial septal defect patients older than 40 years with evidence of mild pulmonary vascular disese as assessed by bicycle stress echocardiography.
 
 
2005-005584-28: Tracleer - Therapie bei Patienten mit Downsyndrom und Eisenmengerreaktion: Verträglichkeit und hämodynamische Wirkungen.

Ongoing
4
20
Europe
Tracleer,
Pediatric Cardiology
Ein wesentlicher Faktor in der Pathogenese der PAH scheint eine gestörte Endothelfunktion mit erhöhter Produktion bzw. vermindertem Abbau von Endothelin-1 zu sein. Bosentan (Tracleer©) ist ein oraler, dualer Endothelin-Rezeptor-Antagonist, der zur Behandlung der PAH auch in Österreich zugelassen ist. Patienten mit Eisenmenger-Komplex stellen eine Besonderheit dar, weil es durch Beeinflussung des pulmonalen Gefäßwiderstandes zu unmittelbaren Rückwirkungen auf den Systemkreislauf kommen kann.
 
 
2014-002796-28: Does therapy with bosentan tablets have positive effects on the stiffness of the vessels in patients with scleroderma who have ulcers of the fingers of toes? Heeft de behandeling met bosentan tabletten possitieve effecten op de stijfheid van de bloedvaten bij patienten met sclerodermie met zweertjes aan de vingers of tenen?

Ongoing
4
40
Europe
Tablet, Tracleer
University Medical Center Groningen (UMCG), University Medical Center Groningen (UMCG)
Systemic sclerosis (SSc) is characterized by skin fibrosis and visceral disease, mainly of the lungs, kidneys and the heart, accompanied by microvascular damage ultimately leading to digital ischemia. Digital ischaemia, digital ulceration (DU) or amputation are well-known manifestations of SSc. Still over 50% of the SSc patients suffer from DU. Despite effort and treatment modalities that have emerged, DU remain an important complication in SSc, even in those with mild disease. Systemische sclerose (SSc) wordt gekarakteriseerd door huidfibrose en schade aan verschillende organen, met name de longen, nieren en het hart zijn aangedaan, gepaard met microvasculaire schade wat uiteindelijk leidt tot digitale ischemie. Digitale ischemie, digitale ulcera (DU) en amputatie zijn bekende manifestaties van SSc. Meer dan 50% van de patiënten hebben DU. Ondanks de nieuwe behandelingen blijven DU een belangrijke complicatie in SSc, ook in patiënten met milde ziekte., Systemic sclerosis (SSc) is a disease wich leads to skinfibrosis and internal organ disease. Over 50% of the SSc patients has ulceration at the fingertips, leading to disability and pain. Systemische sclerose is een ziekte wat kan leiden tot huidverlittekening en orgaanschade. Meer dan 50% van de patiënten heeft zweertjes aan de vingers, wat leidt tot functionele beperking en pijn., Diseases [C] - Skin and Connective Tissue Diseases [C17]
 
 
2004-002686-21: Efficacy of Endothelin 1 receptor antagonist Bosentan in secondary Raynauds Syndrom

Ongoing
3
40
Europe
Bosentan, Ro 47-0203, Film-coated tablet, Tracleer
Dept of Dermatology
secondary Raynauds Syndrome
 
 
2018-004072-35: Study of the value of early treatment in patients with sudden blindness Etude de l’intérêt d’un traitement précoce chez des patients présentant une cécité brutale

Not yet recruiting
3
8
Europe
BOSENTAN MYLAN, Film-coated tablet, BOSENTAN MYLAN
CHU de Nice, CHU de Nice
giant cell arteritis artérite à cellules géantes, visual blindness Cécité visuelle, Diseases [C] - Eye Diseases [C11]
 
 
ENDOTHELION, NCT02377271 / 2014-000848-14: Study Group: Effect of Bosentan in NAION Patients

Recruiting
3
86
Europe
bosentan, placebo
University Hospital, Grenoble
Ischemic Optic Neuropathy
12/23
12/25
MoD, NCT04039464: Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension

Recruiting
3
100
Canada, US
Mono-Therapy with Sildenafil, Revatio monotherapy, Duo-Therapy with Sildenafil + Bosentan, Dual therapy with Revatio and Tracleer
Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI), National Center for Advancing Translational Sciences (NCATS)
Pediatric Pulmonary Hypertension
09/26
09/26
ACTRN12608000236392: Placebo controlled,randomised,crossover study of the efficacy of bosentan in the management of patients with Coronary Slow Flow Phenemenon

Recruiting
2/3
26
 
Cenral Northern Adelaide Health Service - The Queen Elizabeth Hospital, National Heart Foundation grant in aid
Coronary Slow Flow Phenomenon
 
 
EDIT-CAS, NCT06432452: Efficacy of Endothelin Receptor Antagonism in Coronary Artery Spasm

Enrolling by invitation
2/3
100
Europe
Endothelin Receptor Antagonist, Bosentan, Placebo control, Placebo
Radboud University Medical Center, UMC Utrecht, Catharina Ziekenhuis Eindhoven, Maasstad Hospital
Coronary Spasm
06/26
07/26
2005-000701-61: An open label trial of the dual specificity endothelin receptor antagonist bosentan in established scleroderma renal crisis

Ongoing
2
15
Europe
Bosentan, N/A, Tracleer, Tracleer
University College London
Scleroderma renal crisis
 
 
2007-004288-23: Frühtherapie der pulmonal arteriellen Hypertonie (PAH)

Ongoing
2
25
Europe
Tracleer, Tracleer 62,5 mg, Tracleer 125 mg, Tracleer 62,5 mg, Tracleer 125 mg
Medizinische Universität Graz
Exercise induced pulmonary hypertension in patients with connective tissue disaeses
 
 
2010-023822-19: ESTUDIO DE LA EFICACIA DE BOSENTAN EN LA MODULACIÓN DE LA RESPUESTA INFLAMATORIA Y DE LA CICATRIZACIÓN EN PACIENTES QUEMADOS

Ongoing
2
30
Europe
TRACLEER 125 mg comprimidos recubiertos con película, TRACLEER 125 mg comprimidos recubiertos con película
Juan Pedro Barret Nerín
Quemaduras profundas quirúrgicas
 
 
2011-001736-30: BOSENTAN FOR THE TREATMENT OF SKIN ULCERS IN DIABETICMICROANGIOPATHY Bosentan zur Behandlung von Hautulzera bei diabetischer Mikroangiopahtie

Ongoing
2
40
Europe
Tracleer, Tracleer
Med. Univ. Wien, Klinik für Dermatologie, Med. Uni. Wien
Bosentan for the treatment of skin ulcera in diabetic Microangiopathy Bosentan zur Behandlung von Hautulzera bei diabetischer Mikroangiopathie
 
 
2017-001253-13: Does decresaed perfusion of the brain play a role in the reduced function of axons and the clinical disability and fatigue in patients with multiple sclerosis ? Speelt de verminderde doorbloeding van de hersenen een rol in een verminderde functie van de axonen, de cognitieve achteruitgang en vermoeiheid in patiënten met multiple sclerose ?

Ongoing
2
30
Europe
Tablet, Tracleer
UZ Brussel, Charcot Foundation, Actelion Pharmaceuticals, UZ Brussel
Patients suffering relapsing- remitting multiple sclerosis will be investigated in this study, with an EDSS score less or equal to 4.0. Patients must be older than 18 years old. There must not be any clinical evidence of an MS relpase within the 3 months prior to inclusion. Patiënten die lijden aan relapsing-remitting multiple sclerose zullen geïncludeerd worden in deze studie, met een EDSS score kleiner of gelijk aan 4. Patiënten moeten ouder zijn dan 18 jaar. Er mag geen klinische evidentie zijn voor het doorgemaakt hebben van een MS opstoot 3 maanden voorafgaand aan de inclusie., Patients with relapsing-remitting Multiple Sclerosis, older than 18 years old, who are clinically stable at the moment of inclusion. RRMS patiënten, ouder dan 18 jaar, die klinisch stabiel zijn op het moment van de inclusie., Diseases [C] - Immune System Diseases [C20]
 
 
2019-002334-36: VASCULAR AND RENAL IMPACT OF ENDOTHELIN-1 RECEPTOR BLOCKADE IN PATIENTS WITH RESISTANT ARTERIAL HYPERTENSION IMPACT VASCULAIRE ET RENAL DU BLOCAGE DES RECEPTEURS DE L'ENDOTHELINE-1 CHEZ DES PATIENTS ATTEINTS D'HYPERTENSION ARTERIELLE RESISTANTE

Not yet recruiting
2
24
Europe
BOSENTAN MYLAN, Capsule, soft, BOSENTAN MYLAN
CHU de Rouen, CHU de Rouen
Resistant arterial hypertension Hypertension artérielle résistante, Resistant arterial hypertension Hypertension artérielle résistante, Diseases [C] - Symptoms and general pathology [C23]
 
 
ENDOTHELIN-2, NCT04388124: VASCULAR AND RENAL IMPACT OF ENDOTHELIN-1 RECEPTOR BLOCKADE IN PATIENTS WITH RESISTANT ARTERIAL HYPERTENSION

Not yet recruiting
2
24
NA
Bosentan, Placebo
University Hospital, Rouen
Resistant Hypertension
11/22
11/22
DERAIL-LVV, NCT06887062: Dual Endothelin Receptor Antagonism in Large Vessel Vasculitis

Recruiting
2
60
Europe
Bosentan
University of Edinburgh
Large Vessel Vasculitis, Giant Cell Arteritis (GCA), Takayasu Arteritis
07/27
07/27
BOSRET, NCT04068272: Safety of Bosentan in Type II Diabetic Patients

Completed
1
22
Europe
Bosentan, Placebo
Retinset SL, Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Diabetes Mellitus
05/22
05/22
NCT05072106: Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors

Recruiting
1
8
Europe
Lurbinectedin, PM01183, Bosentan
PharmaMar
Advanced Solid Tumor
10/22
11/22
NCT05723874: A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood

Completed
1
14
Europe
BI 425809, iclepertin, bosentan, Tracleer®
Boehringer Ingelheim
Healthy
05/23
05/23
NCT05657613: Drug-Drug Interaction Study of Pacritinib and CYP450,Transporter Substrates, and CYP450 3A4 in Healthy Male Subjects

Completed
1
60
US
CYP450 Cocktail and Transporter Substrates with Pacritinib, Vonjo, Part 2 -Group A Bosentan 125 mg (CYP450 3A4 inducer) with Pacritinib, Part 2 Group B - Fluconazole (CYP450 3A4 inhibitor) with Pacritinib
CTI BioPharma, PPD DEVELOPMENT, LP
Drug Interactions
06/23
06/23
NCT06484673: Bioequivalence Study to Compare Bosentan 32 mg Dispersible Tablets Versus Tracleer® 32 mg Tablets

Completed
1
32
RoW
Bosentan Dispersible Tablets, Tracleer Tablet for Oral Suspension
Humanis Saglık Anonim Sirketi
Pulmonary Arterial Hypertension
05/24
05/24
NCT04158635: Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer

Recruiting
1
21
US
Bosentan, Bosentan Monohydrate, Ro 47-0203, Tracleer, Gemcitabine, dFdC, dFdCyd, Difluorodeoxycytidine, Nab-paclitaxel, ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, protein-bound paclitaxel, Quality-of-Life Assessment, Quality of Life Assessment, Questionnaire Administration
City of Hope Medical Center, National Cancer Institute (NCI)
Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Unresectable Pancreatic Carcinoma
01/26
01/26
ChiCTR-IOR-14005601: Effects of Bosentan on the prognosis in patients after Fontan surgery: a randomized, double-blind, controlled trial

Completed
N/A
 
Wuhan Asia Heart Hospital; Wuhan Asia Heart Hospital, Asian Heart Hospital independent research
Congenital heart disease
 
 
ChiCTR-OON-17013521: Transition from ambrisentan to bosentan in pulmonary arterial hypertension: A single center prospective study

Completed
N/A
20
 
oral ambrisentan ;oral bosentan
Shanghai Pulmonary Hospital; Shanghai Pulmonary Hospital, Self financing
pulmonary arterial hypertension
 
 
ChiCTR-INR-16009511: Clinic investigation on pulmonary artery hypertension associated with connective tissue disease

Not yet recruiting
N/A
120
 
Placebo of Bosentan and Sildenafil ;Sildenafil and placebo of Bosentan ;Bosentan and placebo of Sildenafil ;Bosentan and Sildenafil
Ren Ji Hospital, School of medecine, Shanghai Jiao Tong University; Ren Ji Hospital, School of medecine, Shanghai Jiao Tong University, Three-year project of ShenKang
Pulmonary artery hypertension associated with connective tissue disease
 
 
ChiCTR1900025197: An observational study assessing the transition from Ambrisentan to Bosentan in patients with pulmonary arterial hypertension

Recruiting
N/A
43
 
drug transition
Second Xiangya Hospital of Central South University; Second Xiangya Hospital of Central South University, National Natural Science Foundation of China
pulmonary artery hypertension
 
 
End-Stress, NCT02116335: Endothelin Receptor Function and Acute Stress

Active, not recruiting
N/A
320
US
Bosentan, Tracleer, Placebo, lactose capsule
Augusta University, National Heart, Lung, and Blood Institute (NHLBI)
Hypertension
12/25
01/26
POPS or POP02, NCT04278404: Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

Recruiting
N/A
5000
Canada, US
The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:, Aminocaproic acid, Amiodarone, Bosentan, Budesonide, Cefdinir, Cefepime, Ceftazidime, Clindamycin, Clobazam, Dexamethasone, Dexmedetomidine, Dextroamphetamine/Amphetamine, Fosfomycin, Furosemide, Gabapentin, Guanfacine, Hydrocortisone, Labetalol, Meropenem, Metformin, Milrinone, Nalbuphine, Nicardipine, Nifedipine, Oseltamivir, Oxycodone, Risperidone, Sertraline, Sevelamer Carbonate / Sevelamer Hydrochloride, Spironolactone, Terbutaline, Tranexamic acid, Voriconazole, Zolpidem, Azithromycin, Lopinavir/Ritonavir, Ribavirin, Tocilizumab, Anakinra, Aspirin, Canakinumab, Colchicine, Interferon, Remdesivir, Ruxolitinib, Sarilumab, Abatacept, Infliximab
Duke University, The Emmes Company, LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema, Hypokalemia, Heart Failure, Hemophilia, Menorrhagia, Insomnia, Pneumonia, Skin Infection, Arrythmia, Asthma in Children, Bronchopulmonary Dysplasia, Adrenal Insufficiency, Fibrinolysis; Hemorrhage, Attention Deficit Hyperactivity Disorder, Multisystem Inflammatory Syndrome in Children (MIS-C), Kawasaki Disease, Coagulation Disorder, Down Syndrome
09/26
09/27
NCT05168215: Effectiveness of Bosentan Therapy in Patients With Systemic scleRosis and Progressive Digital ulcEr Disease.

Recruiting
N/A
300
Europe
Elpen Pharmaceutical Co. Inc.
Scleroderma, Digital Ulcer, Autoimmune Diseases, Diffuse Cutaneous Systemic Sclerosis, Reynold Syndrome
06/24
06/24
NCT04379180: Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

Not yet recruiting
N/A
500
RoW
Bosentan Tablets, Sildenafil Tablet, Tadalafil Tablets
Shandong University, West China Second University Hospital
Persistent Pulmonary Hypertension of the Newborn
02/23
05/23
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Tracleer (bosentan) / J&J, Roche
ACTRN12606000289516: Pulmonary Artery Remodelling With Bosentan

Not yet recruiting
4
15
 
Actelion Phrmaceuticals Australia, Actelion Phrmaceuticals Australia
Hypertension, Pulmonary
 
 
2006-003133-33: Etude des effets d’un antagoniste non spécifique de l’endothéline (le bosentan) sur l’activité orthosympathique et le chémoréflexe.

Ongoing
4
20
Europe
Tablet, Tracleer
Hôpital Erasme
healthy subjectsobstructive sleep apnea(Bosentan is used in clinic in pulmonary hypertension)
 
 
ChiCTR-ONC-11001799: A single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease

Completed
4
50
 
Bosentan therapy
Beijing Anzhen Hospital; Beijing Anzhen Hospital, Actelion Pharmaceuticals Ltd
pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease
 
 
2006-005361-19: Evaluation of the efficacy of the dual endothelin 1 receptor antagonist Bosentan in the treatment of Pulmonary Hypertension secondary to Chronic Obstructive Pulmonary Disease and in the treatment of Pulmonary Hypertension secondary to sarcoidosis

Ongoing
4
45
Europe
tracleer, Tracleer, Tracleer
St Georges Hospital
Pulmonary Hypertension secondary to Chronic Obstructive Pulmonary Disease and secondary to SarcoidPatients devolop pulmonary hypertension for various reasons, two common causes are Chronic Obstructive Pulmonary disease and Sarcoid. Once developed it may go on to cause right heart failure and severe breathlessness and eventually death.We believe that the use of bosentan may lower the pulmonary hypertension and improve symptoms.
 
 
2005-005898-29: The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation

Ongoing
4
15
Europe
bosentan, Tracleer, Tracleer
University Hospital Birmingham
Patients with a Fontan circulation (that is they have had a Fontan operation for a functionally univentricular heart)
 
 
2008-004533-21: The role of Bosentan in fontan patients: improvement of aerobic capacity

Ongoing
4
50
Europe
Tracleer, 66215-101, Tracleer, Tracleer
ICIN
To study whether bosentan (endothelin receptor inhibitor) improves aerobic capacity (VO2max) and exercise performance in adult patients with a Fontan operation.
 
 
2009-015602-18: Diabetes and vascular complications: the role of endothelin and physical inactivity’

Ongoing
4
30
Europe
Tracleer, Tracleer-H-C-401-II-40, Tracleer, Tracleer
Actelion Pharmaceuticals
type 2 diabetes mellius
 
 
2010-020209-33: BOsentan for Mild Pulmonary vascular disease in Asd patients (the BOMPA trial): a double-blind, randomized controlled, pilot trial

Ongoing
4
20
Europe
bosentan, C02KX01, Tracleer, Tracleer
University Hospitals Leuven
Repaired (after the age of 40) atrial septal defect patients older than 40 years with evidence of mild pulmonary vascular disese as assessed by bicycle stress echocardiography.
 
 
2005-005584-28: Tracleer - Therapie bei Patienten mit Downsyndrom und Eisenmengerreaktion: Verträglichkeit und hämodynamische Wirkungen.

Ongoing
4
20
Europe
Tracleer,
Pediatric Cardiology
Ein wesentlicher Faktor in der Pathogenese der PAH scheint eine gestörte Endothelfunktion mit erhöhter Produktion bzw. vermindertem Abbau von Endothelin-1 zu sein. Bosentan (Tracleer©) ist ein oraler, dualer Endothelin-Rezeptor-Antagonist, der zur Behandlung der PAH auch in Österreich zugelassen ist. Patienten mit Eisenmenger-Komplex stellen eine Besonderheit dar, weil es durch Beeinflussung des pulmonalen Gefäßwiderstandes zu unmittelbaren Rückwirkungen auf den Systemkreislauf kommen kann.
 
 
2014-002796-28: Does therapy with bosentan tablets have positive effects on the stiffness of the vessels in patients with scleroderma who have ulcers of the fingers of toes? Heeft de behandeling met bosentan tabletten possitieve effecten op de stijfheid van de bloedvaten bij patienten met sclerodermie met zweertjes aan de vingers of tenen?

Ongoing
4
40
Europe
Tablet, Tracleer
University Medical Center Groningen (UMCG), University Medical Center Groningen (UMCG)
Systemic sclerosis (SSc) is characterized by skin fibrosis and visceral disease, mainly of the lungs, kidneys and the heart, accompanied by microvascular damage ultimately leading to digital ischemia. Digital ischaemia, digital ulceration (DU) or amputation are well-known manifestations of SSc. Still over 50% of the SSc patients suffer from DU. Despite effort and treatment modalities that have emerged, DU remain an important complication in SSc, even in those with mild disease. Systemische sclerose (SSc) wordt gekarakteriseerd door huidfibrose en schade aan verschillende organen, met name de longen, nieren en het hart zijn aangedaan, gepaard met microvasculaire schade wat uiteindelijk leidt tot digitale ischemie. Digitale ischemie, digitale ulcera (DU) en amputatie zijn bekende manifestaties van SSc. Meer dan 50% van de patiënten hebben DU. Ondanks de nieuwe behandelingen blijven DU een belangrijke complicatie in SSc, ook in patiënten met milde ziekte., Systemic sclerosis (SSc) is a disease wich leads to skinfibrosis and internal organ disease. Over 50% of the SSc patients has ulceration at the fingertips, leading to disability and pain. Systemische sclerose is een ziekte wat kan leiden tot huidverlittekening en orgaanschade. Meer dan 50% van de patiënten heeft zweertjes aan de vingers, wat leidt tot functionele beperking en pijn., Diseases [C] - Skin and Connective Tissue Diseases [C17]
 
 
2004-002686-21: Efficacy of Endothelin 1 receptor antagonist Bosentan in secondary Raynauds Syndrom

Ongoing
3
40
Europe
Bosentan, Ro 47-0203, Film-coated tablet, Tracleer
Dept of Dermatology
secondary Raynauds Syndrome
 
 
2018-004072-35: Study of the value of early treatment in patients with sudden blindness Etude de l’intérêt d’un traitement précoce chez des patients présentant une cécité brutale

Not yet recruiting
3
8
Europe
BOSENTAN MYLAN, Film-coated tablet, BOSENTAN MYLAN
CHU de Nice, CHU de Nice
giant cell arteritis artérite à cellules géantes, visual blindness Cécité visuelle, Diseases [C] - Eye Diseases [C11]
 
 
ENDOTHELION, NCT02377271 / 2014-000848-14: Study Group: Effect of Bosentan in NAION Patients

Recruiting
3
86
Europe
bosentan, placebo
University Hospital, Grenoble
Ischemic Optic Neuropathy
12/23
12/25
MoD, NCT04039464: Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension

Recruiting
3
100
Canada, US
Mono-Therapy with Sildenafil, Revatio monotherapy, Duo-Therapy with Sildenafil + Bosentan, Dual therapy with Revatio and Tracleer
Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI), National Center for Advancing Translational Sciences (NCATS)
Pediatric Pulmonary Hypertension
09/26
09/26
ACTRN12608000236392: Placebo controlled,randomised,crossover study of the efficacy of bosentan in the management of patients with Coronary Slow Flow Phenemenon

Recruiting
2/3
26
 
Cenral Northern Adelaide Health Service - The Queen Elizabeth Hospital, National Heart Foundation grant in aid
Coronary Slow Flow Phenomenon
 
 
EDIT-CAS, NCT06432452: Efficacy of Endothelin Receptor Antagonism in Coronary Artery Spasm

Enrolling by invitation
2/3
100
Europe
Endothelin Receptor Antagonist, Bosentan, Placebo control, Placebo
Radboud University Medical Center, UMC Utrecht, Catharina Ziekenhuis Eindhoven, Maasstad Hospital
Coronary Spasm
06/26
07/26
2005-000701-61: An open label trial of the dual specificity endothelin receptor antagonist bosentan in established scleroderma renal crisis

Ongoing
2
15
Europe
Bosentan, N/A, Tracleer, Tracleer
University College London
Scleroderma renal crisis
 
 
2007-004288-23: Frühtherapie der pulmonal arteriellen Hypertonie (PAH)

Ongoing
2
25
Europe
Tracleer, Tracleer 62,5 mg, Tracleer 125 mg, Tracleer 62,5 mg, Tracleer 125 mg
Medizinische Universität Graz
Exercise induced pulmonary hypertension in patients with connective tissue disaeses
 
 
2010-023822-19: ESTUDIO DE LA EFICACIA DE BOSENTAN EN LA MODULACIÓN DE LA RESPUESTA INFLAMATORIA Y DE LA CICATRIZACIÓN EN PACIENTES QUEMADOS

Ongoing
2
30
Europe
TRACLEER 125 mg comprimidos recubiertos con película, TRACLEER 125 mg comprimidos recubiertos con película
Juan Pedro Barret Nerín
Quemaduras profundas quirúrgicas
 
 
2011-001736-30: BOSENTAN FOR THE TREATMENT OF SKIN ULCERS IN DIABETICMICROANGIOPATHY Bosentan zur Behandlung von Hautulzera bei diabetischer Mikroangiopahtie

Ongoing
2
40
Europe
Tracleer, Tracleer
Med. Univ. Wien, Klinik für Dermatologie, Med. Uni. Wien
Bosentan for the treatment of skin ulcera in diabetic Microangiopathy Bosentan zur Behandlung von Hautulzera bei diabetischer Mikroangiopathie
 
 
2017-001253-13: Does decresaed perfusion of the brain play a role in the reduced function of axons and the clinical disability and fatigue in patients with multiple sclerosis ? Speelt de verminderde doorbloeding van de hersenen een rol in een verminderde functie van de axonen, de cognitieve achteruitgang en vermoeiheid in patiënten met multiple sclerose ?

Ongoing
2
30
Europe
Tablet, Tracleer
UZ Brussel, Charcot Foundation, Actelion Pharmaceuticals, UZ Brussel
Patients suffering relapsing- remitting multiple sclerosis will be investigated in this study, with an EDSS score less or equal to 4.0. Patients must be older than 18 years old. There must not be any clinical evidence of an MS relpase within the 3 months prior to inclusion. Patiënten die lijden aan relapsing-remitting multiple sclerose zullen geïncludeerd worden in deze studie, met een EDSS score kleiner of gelijk aan 4. Patiënten moeten ouder zijn dan 18 jaar. Er mag geen klinische evidentie zijn voor het doorgemaakt hebben van een MS opstoot 3 maanden voorafgaand aan de inclusie., Patients with relapsing-remitting Multiple Sclerosis, older than 18 years old, who are clinically stable at the moment of inclusion. RRMS patiënten, ouder dan 18 jaar, die klinisch stabiel zijn op het moment van de inclusie., Diseases [C] - Immune System Diseases [C20]
 
 
2019-002334-36: VASCULAR AND RENAL IMPACT OF ENDOTHELIN-1 RECEPTOR BLOCKADE IN PATIENTS WITH RESISTANT ARTERIAL HYPERTENSION IMPACT VASCULAIRE ET RENAL DU BLOCAGE DES RECEPTEURS DE L'ENDOTHELINE-1 CHEZ DES PATIENTS ATTEINTS D'HYPERTENSION ARTERIELLE RESISTANTE

Not yet recruiting
2
24
Europe
BOSENTAN MYLAN, Capsule, soft, BOSENTAN MYLAN
CHU de Rouen, CHU de Rouen
Resistant arterial hypertension Hypertension artérielle résistante, Resistant arterial hypertension Hypertension artérielle résistante, Diseases [C] - Symptoms and general pathology [C23]
 
 
ENDOTHELIN-2, NCT04388124: VASCULAR AND RENAL IMPACT OF ENDOTHELIN-1 RECEPTOR BLOCKADE IN PATIENTS WITH RESISTANT ARTERIAL HYPERTENSION

Not yet recruiting
2
24
NA
Bosentan, Placebo
University Hospital, Rouen
Resistant Hypertension
11/22
11/22
DERAIL-LVV, NCT06887062: Dual Endothelin Receptor Antagonism in Large Vessel Vasculitis

Recruiting
2
60
Europe
Bosentan
University of Edinburgh
Large Vessel Vasculitis, Giant Cell Arteritis (GCA), Takayasu Arteritis
07/27
07/27
BOSRET, NCT04068272: Safety of Bosentan in Type II Diabetic Patients

Completed
1
22
Europe
Bosentan, Placebo
Retinset SL, Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Diabetes Mellitus
05/22
05/22
NCT05072106: Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors

Recruiting
1
8
Europe
Lurbinectedin, PM01183, Bosentan
PharmaMar
Advanced Solid Tumor
10/22
11/22
NCT05723874: A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood

Completed
1
14
Europe
BI 425809, iclepertin, bosentan, Tracleer®
Boehringer Ingelheim
Healthy
05/23
05/23
NCT05657613: Drug-Drug Interaction Study of Pacritinib and CYP450,Transporter Substrates, and CYP450 3A4 in Healthy Male Subjects

Completed
1
60
US
CYP450 Cocktail and Transporter Substrates with Pacritinib, Vonjo, Part 2 -Group A Bosentan 125 mg (CYP450 3A4 inducer) with Pacritinib, Part 2 Group B - Fluconazole (CYP450 3A4 inhibitor) with Pacritinib
CTI BioPharma, PPD DEVELOPMENT, LP
Drug Interactions
06/23
06/23
NCT06484673: Bioequivalence Study to Compare Bosentan 32 mg Dispersible Tablets Versus Tracleer® 32 mg Tablets

Completed
1
32
RoW
Bosentan Dispersible Tablets, Tracleer Tablet for Oral Suspension
Humanis Saglık Anonim Sirketi
Pulmonary Arterial Hypertension
05/24
05/24
NCT04158635: Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer

Recruiting
1
21
US
Bosentan, Bosentan Monohydrate, Ro 47-0203, Tracleer, Gemcitabine, dFdC, dFdCyd, Difluorodeoxycytidine, Nab-paclitaxel, ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, protein-bound paclitaxel, Quality-of-Life Assessment, Quality of Life Assessment, Questionnaire Administration
City of Hope Medical Center, National Cancer Institute (NCI)
Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Unresectable Pancreatic Carcinoma
01/26
01/26
ChiCTR-IOR-14005601: Effects of Bosentan on the prognosis in patients after Fontan surgery: a randomized, double-blind, controlled trial

Completed
N/A
 
Wuhan Asia Heart Hospital; Wuhan Asia Heart Hospital, Asian Heart Hospital independent research
Congenital heart disease
 
 
ChiCTR-OON-17013521: Transition from ambrisentan to bosentan in pulmonary arterial hypertension: A single center prospective study

Completed
N/A
20
 
oral ambrisentan ;oral bosentan
Shanghai Pulmonary Hospital; Shanghai Pulmonary Hospital, Self financing
pulmonary arterial hypertension
 
 
ChiCTR-INR-16009511: Clinic investigation on pulmonary artery hypertension associated with connective tissue disease

Not yet recruiting
N/A
120
 
Placebo of Bosentan and Sildenafil ;Sildenafil and placebo of Bosentan ;Bosentan and placebo of Sildenafil ;Bosentan and Sildenafil
Ren Ji Hospital, School of medecine, Shanghai Jiao Tong University; Ren Ji Hospital, School of medecine, Shanghai Jiao Tong University, Three-year project of ShenKang
Pulmonary artery hypertension associated with connective tissue disease
 
 
ChiCTR1900025197: An observational study assessing the transition from Ambrisentan to Bosentan in patients with pulmonary arterial hypertension

Recruiting
N/A
43
 
drug transition
Second Xiangya Hospital of Central South University; Second Xiangya Hospital of Central South University, National Natural Science Foundation of China
pulmonary artery hypertension
 
 
End-Stress, NCT02116335: Endothelin Receptor Function and Acute Stress

Active, not recruiting
N/A
320
US
Bosentan, Tracleer, Placebo, lactose capsule
Augusta University, National Heart, Lung, and Blood Institute (NHLBI)
Hypertension
12/25
01/26
POPS or POP02, NCT04278404: Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

Recruiting
N/A
5000
Canada, US
The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:, Aminocaproic acid, Amiodarone, Bosentan, Budesonide, Cefdinir, Cefepime, Ceftazidime, Clindamycin, Clobazam, Dexamethasone, Dexmedetomidine, Dextroamphetamine/Amphetamine, Fosfomycin, Furosemide, Gabapentin, Guanfacine, Hydrocortisone, Labetalol, Meropenem, Metformin, Milrinone, Nalbuphine, Nicardipine, Nifedipine, Oseltamivir, Oxycodone, Risperidone, Sertraline, Sevelamer Carbonate / Sevelamer Hydrochloride, Spironolactone, Terbutaline, Tranexamic acid, Voriconazole, Zolpidem, Azithromycin, Lopinavir/Ritonavir, Ribavirin, Tocilizumab, Anakinra, Aspirin, Canakinumab, Colchicine, Interferon, Remdesivir, Ruxolitinib, Sarilumab, Abatacept, Infliximab
Duke University, The Emmes Company, LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema, Hypokalemia, Heart Failure, Hemophilia, Menorrhagia, Insomnia, Pneumonia, Skin Infection, Arrythmia, Asthma in Children, Bronchopulmonary Dysplasia, Adrenal Insufficiency, Fibrinolysis; Hemorrhage, Attention Deficit Hyperactivity Disorder, Multisystem Inflammatory Syndrome in Children (MIS-C), Kawasaki Disease, Coagulation Disorder, Down Syndrome
09/26
09/27
NCT05168215: Effectiveness of Bosentan Therapy in Patients With Systemic scleRosis and Progressive Digital ulcEr Disease.

Recruiting
N/A
300
Europe
Elpen Pharmaceutical Co. Inc.
Scleroderma, Digital Ulcer, Autoimmune Diseases, Diffuse Cutaneous Systemic Sclerosis, Reynold Syndrome
06/24
06/24
NCT04379180: Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN

Not yet recruiting
N/A
500
RoW
Bosentan Tablets, Sildenafil Tablet, Tadalafil Tablets
Shandong University, West China Second University Hospital
Persistent Pulmonary Hypertension of the Newborn
02/23
05/23

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