Sitaxentan

Generic Name: Sitaxentan

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₁₅ClN_₂O_₆S_₂

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.

Clinical Trials

Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery

Phase 2

Completed

Conditions: Cardiac Surgery Subjects
Subjects Undergoing CABG and/or Cardiac Valve Replacement

Interventions: Drug: Placebo
Drug: sitaxsentan (Thelin)

First Posted Date: 2009-02-06

Last Posted Date: 2022-09-08

Lead Sponsor: Pfizer

Target Recruit Count: 29

Registration Number: NCT00838383

Locations: 🇺🇸
University of Pennsylvania,, Philadelphia, Pennsylvania, United States
🇺🇸
The Chattanooga Heart Institute, Chattanooga, Tennessee, United States
🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States

Sitaxsentan in Proteinuric Chronic Kidney Disease

Phase 2

Completed

Conditions: Chronic Kidney Disease
Proteinuria
Blood Pressure

Interventions: Drug: Sitaxsentan
Drug: Placebo tablet
Drug: Nifedipine

First Posted Date: 2009-01-06

Last Posted Date: 2025-02-07

Lead Sponsor: University of Edinburgh

Target Recruit Count: 27

Registration Number: NCT00817037

Locations: 🇬🇧
Clinical Research Centre, Western General Hospital, Edinburgh, Scotland, United Kingdom

A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension

Phase 3

Terminated

Conditions: Pulmonary Arterial Hypertension

Interventions: Drug: Sitaxsentan

First Posted Date: 2008-12-18

Last Posted Date: 2012-04-24

Lead Sponsor: Pfizer

Target Recruit Count: 1192

Registration Number: NCT00811018

Locations: 🇬🇧
Pfizer Investigational Site, Newcastle, United Kingdom

Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety

Phase 3

Terminated

Conditions: Pulmonary Hypertension
Pulmonary Arterial Hypertension

Interventions: Drug: Sitaxsentan
Drug: Sitaxsentan and Sildenafil

First Posted Date: 2008-11-24

Last Posted Date: 2018-10-25

Lead Sponsor: Pfizer

Target Recruit Count: 3

Registration Number: NCT00796510

Locations: 🇺🇦
Pfizer Investigational Site, Kyiv, Ukraine

Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil

Phase 3

Terminated

Conditions: Pulmonary Arterial Hypertension
Pulmonary Hypertension

Interventions: Drug: Sitaxsentan and Sildenafil
Drug: Sitaxsentan

First Posted Date: 2008-11-24

Last Posted Date: 2015-03-24

Lead Sponsor: Pfizer

Target Recruit Count: 131

Registration Number: NCT00796666

Locations: 🇺🇦
Pfizer Investigational Site, Kyiv, Ukraine

Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)

Phase 3

Terminated

Conditions: Pulmonary Arterial Hypertension
Pulmonary Hypertension

Interventions: Drug: Sitaxsentan
Drug: Placebo

First Posted Date: 2008-11-21

Last Posted Date: 2015-03-24

Lead Sponsor: Pfizer

Target Recruit Count: 183

Registration Number: NCT00795639

Locations: 🇺🇦
Pfizer Investigational Site, Kyiv, Ukraine

Proteolytic Enzyme Induction Within the Human Myocardial Interstitium

Not Applicable

Completed

Conditions: Heart Disease

Interventions: Other: Vehicle
Drug: 1mg/kg sitaxsentan sodium
Drug: 2mg/kg sitaxsentan sodium

First Posted Date: 2008-08-29

Last Posted Date: 2017-11-09

Lead Sponsor: VA Office of Research and Development

Target Recruit Count: 29

Registration Number: NCT00744211

Locations: 🇺🇸
Ralph H. Johnson VA Medical Center, Charleston, SC, Charleston, South Carolina, United States

Pharmacogenomics in Pulmonary Arterial Hypertension

Withdrawn

Conditions: PAH WHO Group I
Pulmonary Arterial Hypertension
Pulmonary Hypertension

Interventions: Drug: Sitaxsentan
Drug: Bosentan, Ambrisentan

First Posted Date: 2008-01-15

Last Posted Date: 2021-12-09

Lead Sponsor: West Penn Allegheny Health System

Registration Number: NCT00593905

Locations: 🇺🇸
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States

Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension

Phase 3

Completed

Conditions: Pulmonary Hypertension

First Posted Date: 2004-04-05

Last Posted Date: 2007-11-09

Lead Sponsor: Encysive Pharmaceuticals

Target Recruit Count: 240

Registration Number: NCT00080457

Locations: 🇺🇸
Encysive Pharmaceuticals, Houston, Texas, United States

Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension

Phase 2

Conditions: Pulmonary Hypertension

First Posted Date: 2002-04-25

Last Posted Date: 2005-06-24

Lead Sponsor: ICOS-Texas Biotechnology

Target Recruit Count: 180

Registration Number: NCT00034307

Locations: 🇺🇸
University of Southern California Hospital, Ambulatory Health Sciences, Los Angeles, California, United States
🇺🇸
Harbor-UCLA Medical Center, Torrance, California, United States
🇺🇸
Rush Heart Institute, Center for Pulmonary Heart Disease, Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States

and more 23 locations

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