Sitaxsentan    (DrugBank: Sitaxsentan)

1 disease
告示番号疾患名(ページ内リンク)臨床試験数
86肺動脈性肺高血圧症21

86. 肺動脈性肺高血圧症 [臨床試験数:1,083,薬物数:667(DrugBank:122),標的遺伝子数:98,標的パスウェイ数:185
Searched query = "Pulmonary arterial hypertension", "PAH", "IPAH", "HPAH", "Eisenmenger syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
21 / 1,083 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01251848
(ClinicalTrials.gov)
January 20111/12/2010Drug Interaction Between Ritonavir And SitaxsentanA Phase 1, Open Label, Randomized, Multiple Dose Study To Assess The Two-Way Drug Interaction Between Sitaxsentan And Low Dose Ritonavir In Healthy SubjectsPulmonary Arterial HypertensionDrug: Sitaxentan;Drug: Ritonavir;Drug: SitaxsentanPfizerNULLWithdrawn21 Years55 YearsBoth0Phase 1NULL
2NCT01251835
(ClinicalTrials.gov)
December 20101/12/2010Effect Of Rifampin On Pharmacokinetics Of SitaxsentanA Phase 1, Open Label, Fixed Sequence Design, Multiple Dose Study To Assess The Effect Of Rifampin On The Pharmacokinetics Of Sitaxsentan In Healthy SubjectsPulmonary Arterial HypertensionDrug: Sitaxsentan alone;Drug: Sitaxsentan;Drug: RifampinPfizerNULLWithdrawn21 Years55 YearsBoth0Phase 1NULL
3NCT01244620
(ClinicalTrials.gov)
November 201015/11/2010A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple DosesA Phase 1, Open Label, Randomized, Four Period, Crossover, Multiple Dose Study To Assess The Pharmacokinetic Interaction Between Sitaxsentan and Tadalafil and The Effect Of Sildenafil On Sitaxsentan PK In Healthy SubjectsPulmonary Arterial HypertensionDrug: sitaxentan;Drug: tadalafil;Drug: sitaxsentan;Drug: sildenafilPfizerNULLTerminated21 Years55 YearsAll16Phase 1Singapore
4NCT00796510
(ClinicalTrials.gov)
July 201020/11/2008Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term SafetyA Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Pulmonary HypertensionDrug: Sitaxsentan;Drug: Sitaxsentan and SildenafilPfizerNULLTerminated16 Years80 YearsAll3Phase 3United States;Romania;Ukraine;Argentina;Bulgaria;Chile;China;Colombia;Costa Rica;Czech Republic;Dominican Republic;India;Mexico;Peru;Philippines;Russian Federation;Saudi Arabia;Serbia;Slovakia;South Africa;Thailand
5EUCTR2008-005885-30-CZ
(EUCTR)
12/01/201010/12/2008A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONA PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION Pulmonary arterial hypertension
MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions
Trade Name: Thelin
INN or Proposed INN: SITAXSENTAN SODIUM
Pfizer LtdNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2008-005887-14-CZ
(EUCTR)
12/01/201010/12/2008A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil Citrate
Pfizer Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
7EUCTR2008-005886-78-CZ
(EUCTR)
12/01/201010/12/2008A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONA PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION PULMONARY ARTERIAL HYPERTENSION
MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
8NCT01445873
(ClinicalTrials.gov)
December 1, 200930/9/2011Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH)NON-INTERVENTIONAL (NI) DRUG STUDY PROTOCOL: THREE-COUNTRY PILOT STUDY FOR RETROSPECTIVE CHART REVIEW OF EFFECTIVENESS OF THELIN® (SITAXSENTAN) IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)Pulmonary Arterial HypertensionDrug: Sitaxentan sodiumPfizerNULLCompleted18 YearsN/AAll36NULL
9EUCTR2008-005885-30-BG
(EUCTR)
25/06/200919/06/2009A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONA PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION Pulmonary arterial hypertension
MedDRA version: 13.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Thelin
INN or Proposed INN: SITAXSENTAN SODIUM
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
10EUCTR2008-005887-14-BG
(EUCTR)
25/06/200919/06/2009A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil Citrate
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2008-005886-78-BG
(EUCTR)
25/06/200919/06/2009A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONA PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION PULMONARY ARTERIAL HYPERTENSION
MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
12NCT00796666
(ClinicalTrials.gov)
May 200920/11/2008Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding SildenafilA Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001 (NCT00795639)Pulmonary Arterial Hypertension;Pulmonary HypertensionDrug: Sitaxsentan;Drug: Sitaxsentan and SildenafilPfizerNULLTerminated16 Years80 YearsAll131Phase 3United States;Argentina;Bulgaria;Chile;China;Colombia;Czech Republic;India;Malaysia;Mexico;Peru;Romania;Russian Federation;Serbia;South Africa;Thailand;Turkey;Ukraine;Costa Rica;Dominican Republic;Philippines;Saudi Arabia;Slovakia
13EUCTR2008-005886-78-SK
(EUCTR)
06/04/200920/02/2009A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONA PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION PULMONARY ARTERIAL HYPERTENSION
MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Limited, Ramsgate Road, Sandwich, Kent UKNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Slovakia;Bulgaria
14EUCTR2008-005885-30-SK
(EUCTR)
06/04/200920/02/2009A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONA PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION Pulmonary arterial hypertension
MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions
Trade Name: Thelin
INN or Proposed INN: SITAXSENTAN SODIUM
Pfizer LimitedNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Slovakia;Bulgaria
15EUCTR2008-005887-14-SK
(EUCTR)
01/04/200920/02/2009A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil Citrate
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Slovakia;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT01100736
(ClinicalTrials.gov)
January 200930/3/2010Role of Endothelin-A (ETA) and Endothelin-B (ETB) Receptors in the Vasodilatory Response to Endothelin-3 (ET-3)Characterisation of the Role of ETA and ETB Receptors in Regulating Plasma ET-1 and the Vasodilator Response to ET-3 in ManPulmonary Arterial Hypertension;Vasodilation;VasoconstrictionDrug: Bosentan;Drug: Sitaxsentan;Drug: Placebo;Biological: Endothelin-3University of EdinburghEncysive PharmaceuticalsCompleted18 Years70 YearsBoth10Phase 0United Kingdom
17NCT00795639
(ClinicalTrials.gov)
December 200820/11/2008Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Pulmonary HypertensionDrug: Sitaxsentan;Drug: PlaceboPfizerNULLTerminated16 Years80 YearsAll183Phase 3United States;Argentina;Bulgaria;Chile;China;Colombia;Costa Rica;Czech Republic;Dominican Republic;Guatemala;India;Malaysia;Mexico;Peru;Philippines;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;South Africa;Thailand;Turkey;Ukraine;Egypt;Jordan;Lebanon;United Arab Emirates
18NCT00593905
(ClinicalTrials.gov)
July 20053/1/2008Pharmacogenomics in Pulmonary Arterial HypertensionPharmacogenomics in Pulmonary Arterial Hypertension: A Multi-Center International Study to Determine Whether in PAH Patients Clinical Associations Exist Between the Efficacy and Toxicity of Endothelin Receptor Antagonists and Several Gene Polymorphisms in Several Key Disease-Specific and Therapy Specific GenesPulmonary Arterial Hypertension;Pulmonary Hypertension;PAH WHO Group IDrug: Sitaxsentan;Drug: Bosentan, AmbrisentanWest Penn Allegheny Health SystemNational Institutes of Health (NIH);Baylor College of Medicine;Emory University;University of Chicago;Johns Hopkins University;Tufts Medical Center;Sir Mortimer B. Davis - Jewish General Hospital;London Health Sciences Centre;University of Maryland;University of California, San Francisco;University of Calgary;Chest Medical Associates;Columbia University;Lung Diagnostics, Ltd.;Duke University;University of California, Los Angeles;Latter Day Saints Hospital;Louisiana State University Health Sciences Center in New Orleans;Massachusetts General Hospital;Mayo Clinic;Medical College of Wisconsin;Southeastern Lung Care;Suncoast Lung Center;Children's Hospital Colorado;University Hospital Case Medical Center;University of Colorado, Denver;University of Michigan;University of Pittsburgh;University of Southern California;The University of Texas, Galveston;Vanderbilt University;Wayne State University;Ohio State University;University of Alabama at Birmingham;Washington University School of Medicine;Sentara Norfolk General Hospital;University of Texas Southwestern Medical Center;Bay Area Chest PhysiciansRecruitingN/AN/ABoth1300N/AUnited States
19NCT00080457
(ClinicalTrials.gov)
May 20031/4/2004Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial HypertensionA Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium (Thelin™) Treatment With an Open-Label Bosentan Arm in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary HypertensionDrug: sitaxsentan sodiumEncysive PharmaceuticalsNULLCompleted12 Years75 YearsBoth240Phase 3United States
20NCT00811018
(ClinicalTrials.gov)
March 20039/12/2008A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial HypertensionA Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: SitaxsentanPfizerNULLTerminated12 Years75 YearsAll1192Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT00034307
(ClinicalTrials.gov)
February 200224/4/2002Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial HypertensionA Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: sitaxsentan sodiumICOS-Texas BiotechnologyICOS Corporation;Texas Biotechnology CorporationActive, not recruiting16 Years75 YearsBoth180Phase 2;Phase 3United States;Canada