Bosentan

Generic Name: Bosentan

Brand Names: Stayveer, Tracleer

Drug Type: Small Molecule

Chemical Formula: C_₂₇H_₂₉N_₅O_₆S

CAS Number: 147536-97-8

Unique Ingredient Identifier: XUL93R30K2

Background: Bosentan is a dual endothelin receptor antagonist marketed under the trade name Tracleer by Actelion Pharmaceuticals. Bosentan is used to treat pulmonary hypertension by blocking the action of endothelin molecules that would otherwise promote narrowing of the blood vessels and lead to high blood pressure.

Indication: Used in the treatment of pulmonary arterial hypertension (PAH), to improve exercise ability and to decrease the rate of clinical worsening (in patients with WHO Class III or IV symptoms).

Associated Conditions: NYHA Functional Class II-IV Pulmonary arterial hypertension, Ocular Inflammation, Ocular bacterial infections

Associated Therapies: -

Clinical Trials

Examination of the Bronchoprotective Effect of Endothelin Receptor Blockade in Asthma

Phase 2

Conditions: Asthma

Interventions: Drug: Ambrisentan
Drug: Placebo
Drug: Bosentan

First Posted Date: 2012-06-12

Last Posted Date: 2012-06-12

Lead Sponsor: University of Glasgow

Target Recruit Count: 18

Registration Number: NCT01617746

Locations: 🇬🇧
Asthma Research Unit, University of Glasgow, Glasgow, United Kingdom

Bosentan for Treatment of Hepatopulmonary Syndrome in Patients With Liver Cirrhosis

Phase 2

Terminated

Conditions: Liver Cirrhosis
Hepatopulmonary Syndrome

Interventions: Drug: Placebo
Drug: bosentan

First Posted Date: 2012-01-26

Last Posted Date: 2016-09-28

Lead Sponsor: Medical University of Vienna

Target Recruit Count: 6

Registration Number: NCT01518595

Locations: 🇦🇹
Medical University Vienna, Dpt. of Internal Medicine 3, Div. of Gastroenterology and Hepatology, Vienna, Austria

Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia

Phase 4

Conditions: Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia

Interventions: Drug: Sildenafil
Drug: Bosentan

First Posted Date: 2011-10-10

Last Posted Date: 2013-01-29

Lead Sponsor: All India Institute of Medical Sciences, New Delhi

Target Recruit Count: 60

Registration Number: NCT01449253

Locations: 🇮🇳
All India Institute Of Medical Sciences, New Delhi, Delhi, India

Treatment of Thromboangiitis Obliterans (Buerguer's Disease) With Bosentan

Completed

Conditions: Thromboangiitis Obliterans

Interventions: Drug: Bosentan

First Posted Date: 2011-10-06

Last Posted Date: 2016-08-16

Lead Sponsor: Hospital Universitario Getafe

Target Recruit Count: 12

Registration Number: NCT01447550

Locations: 🇪🇸
Hospital Universitario de Getafe, Getafe, Spain
🇪🇸
Hospital Universitario Getafe, Getafe, Madrid, Spain

Influence of OATP1B1 and CYP2C9 Genotypes on the Pharmacokinetics of Bosentan Before and During Clarithromycin

Completed

Conditions: Drug Interactions

Interventions: Drug: Bosentan

First Posted Date: 2011-08-29

Last Posted Date: 2017-05-31

Lead Sponsor: Gerd Mikus

Target Recruit Count: 16

Registration Number: NCT01425229

Locations: 🇩🇪
University Hospital Heidelberg, Heidelberg, Germany

Bosentan in Systemic Sclerosis

Phase 4

Completed

Conditions: Systemic Sclerosis
Digital Ulcers

Interventions: Drug: Bosentan

First Posted Date: 2011-07-18

Last Posted Date: 2014-01-07

Lead Sponsor: Actelion

Target Recruit Count: 18

Registration Number: NCT01395732

Locations: 🇳🇱
Erasmus MC, Rotterdam, Netherlands
🇳🇱
LUMC, Leiden, Netherlands
🇳🇱
UMC Groningen, Groningen, Netherlands

and more 7 locations

Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants

Phase 3

Completed

Conditions: Pulmonary Arterial Hypertension

Interventions: Drug: Imatinib
Drug: Sildenafil
Drug: Bosentan

First Posted Date: 2011-07-12

Last Posted Date: 2021-06-21

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 21

Registration Number: NCT01392469

Locations: 🇬🇧
Novartis Investigative Site, London, United Kingdom

Persistent Pulmonary Hypertension of the Newborn

Phase 3

Terminated

Conditions: Persistent Pulmonary Hypertension of the Newborn

Interventions: Drug: Matching placebo
Drug: Bosentan

First Posted Date: 2011-07-08

Last Posted Date: 2015-05-01

Lead Sponsor: Actelion

Target Recruit Count: 23

Registration Number: NCT01389856

Locations: 🇺🇸
LURIE CHILDREN'S HOSPITAL OF CHICAGO - Site 6021, Chicago, Illinois, United States
🇺🇸
Advocate Hope Children's Hospital - Site 6009, Oak Lawn, Illinois, United States
🇦🇺
The Royal Children's Hospital, Department of Neonatology - Site 3001, Parkville, Australia

and more 22 locations

Effect of Bosentan on Endothelial Function in Patients With Type 2 Diabetes

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Bosentan
Drug: Placebo

First Posted Date: 2011-05-20

Last Posted Date: 2011-05-20

Lead Sponsor: Karolinska Institutet

Target Recruit Count: 56

Registration Number: NCT01357109

Locations: 🇸🇪
Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden

Characterization and Detection of Prolonged Endothelin Receptors Antagonists Administration

Phase 2

Completed

Conditions: Pulmonary Hypertension

Interventions: Drug: Placebo
Drug: Bosentan
Drug: Ambrisentan

First Posted Date: 2011-05-11

Last Posted Date: 2013-05-08

Lead Sponsor: Center for Health, Exercise and Sport Sciences, Serbia

Target Recruit Count: 30

Registration Number: NCT01352065

Locations: 🇷🇸
Center for Health, Exercise and Sport Sciences, Belgrade, Serbia

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