MedPath

Sitaxentan

Generic Name
Sitaxentan
Drug Type
Small Molecule
Chemical Formula
C18H15ClN2O6S2
CAS Number
184036-34-8
Unique Ingredient Identifier
J9QH779MEM
Background

Sitaxentan was marketed under the trade name Thelin for the treatment of pulmonary arterial hypertension (PAH) by Encysive Pharmaceuticals until Pfizer purchased Encysive in February 2008. In 2010, Pfizer voluntarily removed sitaxentan from the market over concerns of hepatotoxicity.

Indication

Investigated for use/treatment in pulmonary hypertension, connective tissue diseases, hypertension, and congestive heart failure.

Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)

Completed
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2011-10-04
Last Posted Date
2020-09-01
Lead Sponsor
Pfizer
Target Recruit Count
36
Registration Number
NCT01445873

Drug Interaction Between Ritonavir And Sitaxsentan

Phase 1
Withdrawn
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2010-12-02
Last Posted Date
2015-03-05
Lead Sponsor
Pfizer
Registration Number
NCT01251848

Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan

Phase 1
Withdrawn
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2010-12-02
Last Posted Date
2015-03-05
Lead Sponsor
Pfizer
Registration Number
NCT01251835

A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses

Phase 1
Terminated
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2010-11-19
Last Posted Date
2012-02-22
Lead Sponsor
Pfizer
Target Recruit Count
16
Registration Number
NCT01244620
Locations
🇸🇬

Pfizer Investigational Site, Singapore, Singapore

Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients

Phase 3
Terminated
Conditions
Hypertension, Pulmonary
Interventions
First Posted Date
2010-09-28
Last Posted Date
2011-12-14
Lead Sponsor
Pfizer
Target Recruit Count
2
Registration Number
NCT01210443
Locations
🇯🇵

Pfizer Investigational Site, Shinjyuku-ku, Tokyo, Japan

A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients

Phase 3
Terminated
Conditions
Hypertension, Pulmonary
Interventions
First Posted Date
2010-09-17
Last Posted Date
2011-12-01
Lead Sponsor
Pfizer
Target Recruit Count
2
Registration Number
NCT01204853
Locations
🇯🇵

Pfizer Investigational Site, Shinjyuku-ku, Tokyo, Japan

Role of Endothelin-A (ETA) and Endothelin-B (ETB) Receptors in the Vasodilatory Response to Endothelin-3 (ET-3)

Early Phase 1
Completed
Conditions
Vasoconstriction
Pulmonary Arterial Hypertension
Vasodilation
Interventions
Drug: Placebo
Biological: Endothelin-3
First Posted Date
2010-04-09
Last Posted Date
2015-07-21
Lead Sponsor
University of Edinburgh
Target Recruit Count
10
Registration Number
NCT01100736
Locations
🇬🇧

Clinical Research Centre, Western General Hospital, Edinburgh, Scotland, United Kingdom

Study on the Effects of Sitaxsentan on Airway Remodeling in Patients With Severe Asthma

Phase 2
Terminated
Conditions
Effect of Sitaxsentan on Airway Remodeling in Severe Asthma
Interventions
Drug: placebo
First Posted Date
2010-01-15
Last Posted Date
2012-05-10
Lead Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Target Recruit Count
17
Registration Number
NCT01050491
Locations
🇫🇷

Clinical Investigation center 07, Hopital Bichat, Paris, France

A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin

Terminated
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2009-10-15
Last Posted Date
2012-02-07
Lead Sponsor
Pfizer
Target Recruit Count
54
Registration Number
NCT00995566
Locations
🇩🇪

Pfizer Investigational Site, Hannover, Germany

Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-09-22
Last Posted Date
2010-10-15
Lead Sponsor
Pfizer
Target Recruit Count
22
Registration Number
NCT00981968
Locations
🇺🇸

Pfizer Investigational Site, Glendale, California, United States

© Copyright 2025. All Rights Reserved by MedPath