8 terminated, 4 completed, 3 withdrawn. 6 Phase 3, 4 Phase 2, 3 Phase 1, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Terminated 6 |
| Phase 2 | 4 | Completed 3, Terminated 1 |
| Phase 1 | 3 | Withdrawn 2, Terminated 1 |
| Early Phase 1 | 1 | Completed 1 |
Follow sitaxsentan: new trials by email Literature Review of sitaxsentan trials Research Report on sitaxsentan
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Drug Interaction Between Ritonavir And Sitaxsentan Sitaxentan, Ritonavir, Sitaxsentan - Pulmonary Arterial Hypertension | Phase 1 | Withdrawn | Pfizer | 2011-01-01 | 2015-03-05 | |
| Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan Sitaxsentan alone, Sitaxsentan, Rifampin - Pulmonary Arterial Hypertension | Phase 1 | Withdrawn | Pfizer | 2010-12-01 | 2015-03-05 | |
| Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients Sitaxentan - Hypertension, Pulmonary | Phase 3 | Terminated | Pfizer | 2 | 2010-11-01 | 2011-12-14 |
| A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses sitaxentan, tadalafil, sitaxsentan - Pulmonary Arterial Hypertension | Phase 1 | Terminated | Pfizer | 16 | 2010-11-01 | 2012-02-22 |
| A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients Sitaxentan - Hypertension, Pulmonary | Phase 3 | Terminated | Pfizer | 2 | 2010-08-01 | 2011-12-01 |
| Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety Sitaxsentan, Sitaxsentan and Sildenafil - Pulmonary Arterial Hypertension, Pulmonary Hypertension | Phase 3 | Terminated | Pfizer | 3 | 2010-07-01 | 2018-10-25 |
| Study on the Effects of Sitaxsentan on Airway Remodeling in Patients With Severe Asthma sitaxentan, placebo - Effect of Sitaxsentan on Airway Remodeling in Severe Asthma | Phase 2 | Terminated | Institut National de la Santé Et de la Recherche Médicale, France | 17 | 2009-11-01 | 2012-05-10 |
| 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 Sitaxsentan, Sitaxsentan and Sildenafil - Pulmonary Arterial Hypertension, Pulmonary Hypertension | Phase 3 | Terminated | Pfizer | 131 | 2009-05-01 | 2015-03-24 |
| Role of Endothelin-A (ETA) and Endothelin-B (ETB) Receptors in the Vasodilatory Response to Endothelin-3 (ET-3) Bosentan, Sitaxsentan, Placebo - Pulmonary Arterial Hypertension, Vasodilation | Early Phase 1 | Completed | University of Edinburgh | 10 | 2009-01-01 | 2015-07-21 |
| Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS) Sitaxsentan, Placebo - Pulmonary Arterial Hypertension, Pulmonary Hypertension | Phase 3 | Terminated | Pfizer | 183 | 2008-12-01 | 2015-03-24 |
| Sitaxsentan in Proteinuric Chronic Kidney Disease Sitaxsentan, Nifedipine, Placebo tablet - Chronic Kidney Disease, Proteinuria | Phase 2 | Completed | University of Edinburgh | 27 | 2007-07-14 | 2025-02-07 |
| Effects Of Sitaxsentan On Proteinuria, 24-Hour Blood Pressure, And Arterial Stiffness In Chronic Kidney Disease Subjects Open, Nifedipine, Placebo - Chronic Kidney Disease | Phase 2 | Completed | Pfizer | 27 | 2007-05-09 | 2023-07-06 |
| Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery sitaxsentan (Thelin), Placebo - Cardiac Surgery Subjects, Subjects Undergoing CABG and/or Cardiac Valve Replacement | Phase 2 | Completed | Pfizer | 29 | 2006-08-10 | 2022-09-08 |
| Pharmacogenomics in Pulmonary Arterial Hypertension Sitaxsentan, Bosentan, Ambrisentan - Pulmonary Arterial Hypertension, Pulmonary Hypertension | Withdrawn | West Penn Allegheny Health System | 2005-07-01 | 2021-12-09 | ||
| A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension Sitaxsentan - Pulmonary Arterial Hypertension | Phase 3 | Terminated | Pfizer | 1192 | 2003-03-01 | 2012-04-24 |
Pulmonary Arterial Hypertension (9) · Hypertension, Pulmonary (6) · Renal Insufficiency, Chronic (2) · Airway Obstruction (1) · Airway Remodeling (1) · Aneurysm (1) · Asthma (1) · Familial Primary Pulmonary Hypertension (1) · Proteinuria (1)
Pfizer (11) · University of Edinburgh (2) · Institut National de la Santé Et de la Recherche Médicale, France (1) · West Penn Allegheny Health System (1)
United States (6) · United Kingdom (4) · Argentina (3) · Mexico (3) · Romania (3) · Ukraine (3) · Bulgaria (2) · Chile (2) · China (2) · Colombia (2) · Czechia (2) · France (2) · India (2) · Japan (2) · Malaysia (2)
David Webb, MD DSc FRCP FRSE FMedSci (1) · Neeraj Dhaun, MBChB (1) · Raymond L Benza, MD (1)
PMID 21357275, PMID 23243212, PMID 24890823, PMID 25801761, PMID 31177906