DDrare: Database of Drug Development for Rare Diseases

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.

Drug = (-)-Epicatechin; (Pyr1)apelin-13; (S)-2-(4,6-dimethylpyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropanoic acid; (S)-3-((3-(1-((6-(3,4-DIMETHOXYPHENYL)PRYAZIN-2-YL)AMINO)ETHYL)PHENYL)CARBAMOYL)-5-METHYLPRIDIN-1-IUM; **Comment**- IMP inhalation solution identical to ventavis inhalation solution, but IMP is in a different volume presentation. Please see covering letter.; 10-nitro-9(E)-octadec-9-enoic acid; 11C-ACETATE; 11C-acetate; 120 mg sodium nitrite inhalation solution; 15 mg sodium nitrite inhalation solution; 150mg CXA-10; 171; 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide; 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl) acetamide; 20 mg sildenafil citrate by mouth; 25% MTD sodium nitrite inhalation solution; 45 mg sodium nitrite inhalation solution; 4AU76; 66215-101; 6R-BH4; 75mg CXA-10; 90 mg sodium nitrite inhalation solution; : 2-{4-[(5,6-difenilpirazin-2-yl)(isopropil)amino]butoxi}-N-; ABI-009, nab-rapamycin, albumin-bound rapamycin; ACE-011; ACT - 064992; ACT-050089; ACT-050089 (Ro 61-0612); ACT-064992; ACT-064992D; ACT-178418; ACT-293987; ACT-293987 (NS-304); ACT-385781A; ACT-385781A (Actelion Epoprostenol); ADCIRCA 20 mg film-coated tablets; ADEMPAS; ADEMPAS - 0,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; ADEMPAS - 1 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; ADEMPAS - 1,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; ADEMPAS - 2 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; ADEMPAS - 2,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE; AIR001; AIR001 (sodium nitrite inhalation solution); AIR001 Inhalation Solution; AIR001 Inhalation Solution (Expansion arm); AL; AMBRISENTAN; AMN107; APD811; APN01; AR392830; AZD4831; Access program - sildenafil citrate, Viagra, Revatio; Acetamide; Acetaminophen; Acetate; ActRIIA-IgG1Fc; Adcirca; Adcirca®; Adempas; Adempas (Riociguat, BAY63-2521); Adempas 0.5 mg; Adempas 0.5 mg Film Coated Tablet; Adempas 1 mg Film Coated Tablet; Adempas 1.0 mg; Adempas 1.5 mg; Adempas 1.5 mg Film Coated Tablet; Adempas 2 mg Film Coated Tablet; Adempas 2.0 mg; Adempas 2.5 mg; Adempas 2.5 mg Film Coated Tablet; Adempas®; Adempas® 0.5 mg film-coated tablets; Adempas® 1.0 mg film-coated tablets; Adempas® 1.5 mg film-coated tablets; Adempas® 2.0 mg film-coated tablets; Adempas® 2.5 mg film-coated tablets; Adempas¿ 0.5 mg compressa rivestita con film; Adempas¿ 1.0; Adempas¿ 1.5 mg; Adempas¿ 2.0 mg; Adempas¿ 2.5 mg; Adipose derived mesenchymal stem cells; Aerosolized iloprost; Albuterol; Albuterol first; Albuterol.; Allogeneic Human Cardiosphere-Derived Stem Cells; Ambrisentan; Ambrisentan - high dose; Ambrisentan - low dose; Ambrisentan 5 mg film-coated tablets; Ambrisentan 5mg film-coated tablets [marketed product]; Ambrisentan Tablet; Ambrisentan plus Spironolactone; Ammonia; Anakinra; Anastrozole; Angiotensin; Apabetalone; Apelin; Aspirin; Assigned pulmonary hypertension medication; Autologous EPCs transfected; Autologous EPCs transfected with human eNOS; Aviptadil; BARDOXOLONE METHYL, CDDO-Me, CDDO-Methyl Ester, NSC 713200, Chemical Name: Oleana-1,9(11)-dien-28-oic acid, 2-cyano-3,12-dioxo-, methyl ester; BAY 63-2521; BAY 63-2521 0.06 %; BAY 63-2521 0.3 %; BAY 63-2521 IR tablets 0.5 mg; BAY 63-2521 IR tablets 1 mg; BAY 63-2521 IR tablets 1.0 mg; BAY 63-2521 IR tablets 1.5 mg; BAY 63-2521 IR tablets 2.0 mg; BAY 63-2521 IR tablets 2.5 mg; BAY 63-2521 Tablet; BAY 63-2521 coated tablets 0.5 mg; BAY 63-2521 coated tablets 1 mg; BAY 63-2521 coated tablets 1.5 mg; BAY 63-2521 coated tablets 2 mg; BAY 63-2521 coated tablets 2.5 mg; BAY 63-2521 tablets 0.5 mg; BAY 63-2521 tablets 1 mg; BAY 63-2521 tablets 1.5 mg; BAY 63-2521 tablets 2 mg; BAY 63-2521 tablets 2.5 mg; BAY1237592; BAY63-2521; BENZBROMARONE; BH4; BIA; BIA 5-1058; BIA-5-1058; BOSENTAN; BOSENTAN MONOHIDRATO; BOSENTAN MONOHYDRATE; BPS-314d-MR; BPS-MR; BSF 208075; BSF 208075 or LU 208075; Bardoxolone; Bardoxolone Methyl; Bardoxolone methyl; Bardoxolone methyl capsules; Bay Q 6256; Bay q 6256; Beetroot juice; Benzbromaron; Benzbromaron AL; Benzbromarone; Beraprost; Beraprost Sodium; Beraprost Sodium 314d Modified Release Tablets; Beraprost Sodium Modified Release; Beraprost sodium modified release; Bevacizumab; Biological DMARDs; Bisoprolol; Blood Test; Bosentan; Bosentan administration; Bosentan and Sildenafil; Bosentan monohydrat; Bosentan monohydrate; Bosentan, Ambrisentan; Bromure d'Ipratropium; C07AB07; C225; CIALIS; CIALIS 20 mg comprimidos recubiertos con película; CJNJ-68150420-ZZZ-G001 (ACT- 064992D); CJNJ-68150420-ZZZ-G001 (ACT-064992D); CJNJ-68150420-ZZZ-G001(ACT-064992D); CXA-10; Capsaicin; Captopril; Carbon; Carbon Monoxide; Carbon monoxide; Carvedilol; Cetuximab; Chlorhexidine; Cialis; Cialis 10 mg film-coated tablets; Cialis 2.5 mg film-coated tablets; Cialis 20 mg film-coated tablets; Cialis 5 mg film-coated tablets; Cicletanine; Cicletanine hydrochloride; Citrulline; Clopidogrel; Coenzyme Q-10; Coenzyme Q-10 in Normal Control subjects; Coenzyme Q-10 in Pulmonary Hypertension subjects; Combination Product:  Device: Axially Oscillating Sphere dry powder inhaler (AOS DPI); Combination Product: Implantable System for Remodulin (treprostinil); Combination Product: Treprostinil via implanted pump; Commercial Ventavis® (iloprost); Conivaptan; Conventional drug therapy(expectorant,bronchodilator); CosmoFer; Current marketed FLOLAN (epoprostenol sodium); D-glucose; DHEA; DHEA tablet; Device: Breelib nebulizer; Device: Crono Five ambulatory pump; Device: EndoPAT measurement; Device: Generic Dry Powder Inhaler; Device: I-Neb AAD system; Device: L606 Inhalation System; Device: Usual Care; Device: mHealth Intervention; Diagnostic Test: CMRI; Diagnostic Test: Cardiac MRI (Gadolinium enhanced); Diagnostic Test: Endogenous thrombin potential; Diagnostic Test: Light transmission aggregometry; Diagnostic Test: PET-CT Imaging with [89Zr]-bevacizumab; Diagnostic Test: Platelet function analyzer-100; Diagnostic Test: Rotational thromboelastometry; Dichloroacetate; Dichloroacetate Sodium; Dietanolamina de treprostinilo; Diltiazem; Diltiazem Hydrochloride; Dimethyl Fumarate (DMF); Dimethyl fumarate; Diphenhydramine; Duo-Therapy with Sildenafil + Bosentan; EFI/ACT-385781A; ENOS transfected EPCs will be delivered via a PA line; EPOPROSTENOL; EPOPROSTENOL SODICO; EPOPROSTENOL SODIUM; ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan); ERA as specific PAH treatment; ESR-specific PET scan; Elafin; Endothelin receptor antagonist therapy; Endothelin-3; Epicatechin; Epoprostenol; Epoprostenol for injection; Epoprostenol-Actelion; Epoprostenolo per iniezione; Equal; Erbitux; Esomeprazole; Esuberaprost; Eutonic Treprostinil Solution; FDC macitentan/tadalafil; FERRIC CARBOXYMALTOSE; FK506 level 2-3 ng/ml; FK506 level 3-5 ng/ml; FK506 level < 2 ng/ml; FLOLAN TM and Glycine Diluent; FLOLAN injection with currently marketed diluent; FLOLAN injection with reformulated diluent; FLOLAN™ and Glycine Diluent; Famotidine; Famotidine 20 MG; Ferinject; Ferinject or CosmoFer; Ferric carboxymaltose; Ferricarboxymaltose; Flolan; Flolan®; Fluoxetine; Fulvestrant; G04BE03; G04BE03- Sildenafil - sildenafil (citrato); GB002; GB002 Capsules; GLIVEC; GLIVEC 100 mg comprimidos recubiertos con película; GMA301 Injection; GS-4997 18 mg; GS-4997 2 mg; GS-4997 6 mg; GSK1325760; GSK1325760A; GSK2256098; GSK2586881; Gadolinium; Glivec; Glivec 100 mg Filmtabletten; Glivec 100 mg Hartkapsel; Glivec®; Glivec® 100 mg Filmtabletten; Glucose; Glycine; Gold; Gradient; HGP1206; Hydroxyurea; HypotonicTreprostinil Solution; I.v. selexipag; ILOPROST; IMATINIB; IMATINIB MESILATE; IMATINIB MESYLATE; INO; Ifetroban; Ilomedin 20; Ilomedin 20 [20 µg / ml]; Iloprost; Iloprost (5 µg); Iloprost (Ventavis BAYQ6256); Iloprost (Ventavis inhaled, BAYQ6256); Iloprost (Ventavis, BAYQ 6256); Iloprost (Ventavis, BAYQ6256); Iloprost (Ventavis®); Iloprost Inhalation Solution (Ventavis); Iloprost PD-15; Iloprost PD-6; Iloprost,(Ventavis, BAYQ6256); Imatinib; Imatinib Mesylate; Imatinib mesilate; Imatinib mesylate; Inhaled Iloprost (5 µg); Inhaled NO with pulsed delivery; Inhaled Nitric Oxide; Inhaled Nitric Oxide 75 mcg/kg IBW/hr; Inhaled dry powder treprostinil (LIQ861); Inhaled iloprost (Ventavis, BAYQ6256); Inhaled nitric oxide & INOpulse delivery; Inhaled prostacyclin; Inhaled treprostinil; Intravenous Treprostinil; Intravenous administration of ferric carboxymaltose; Intravenous/Subcutaneous Treprostinil; Ipratropium; Iron supplement; JNJ-67896049; JNJ-67896049 (ACT-293987); JNJ-67896062 / ACT-064992; JTT-251; KAR5585 Capsules; L-Citrulline Malate; L606 (Liposomal Treprostinil) Inhalation Solution 51ug; LIQ861 100 µg; LIQ861 106 µg; LIQ861 25 µg; LIQ861 26.5 µg; LIQ861 50 µg; LIQ861 53 µg; LIQ861 75 µg; LIQ861 79.5 µg; LIQ861 Inhaled Treprostinil; LY450190; Levitra; Lidocaine; Lisuride; Lloprost(Ventavis,BAYQ6252, 10 µg/mL); Lloprost(Ventavis,BAYQ6252, 20 µg/mL); MACITENTAN; MD-711; MK-5475; MK-8892; MONITOR; Macitentan; Macitentan (ACT-064992); Macitentan 10 mg; Macitentan 10 mg tablet, once daily.; Macitentan 37.5 mg; Macitentan 75 mg; Macitentan Group; Macitentan tablets; Medical air; Metformin; Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo; Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb; Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth; Methylprednisolone; Mono-Therapy with Sildenafil; Morphine; Morphine Sulfate; Moxifloxacin; Moxifloxacin 400 mg; MultiHance; NITRIC OXIDE; NS-304; NX1011; Nebulized combination ipratropium bromide with salbutamol; Nebulized ipratropium bromide; New thermo stable formulation of epoprostenol sodium; Nicardipine; Nilotinib; Nilotinib 50 mg; Nitric Oxide; Nitric Oxide for inhalation; Nitric Oxide generated by the GeNO nitrosyl delivery system; Nitric Oxide plus Oxygen; Nitrite; Nitrosyl; Non-Biologic DMARDs; Null; OXYGEN; Observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi; Olaparib; Opsumit; Opsumit (macitentan); Opsumit®; Oral ERA; Oral Ifetroban; Oral PDE5 inhibitors; Oral Treprostinil; Oral anticoagulant treatment; Oral selexipag (Uptravi); Oral sildenafil; Oral treprostinil; Oral treprostinil (UT-15C) Sustained Release Tablets; Oral treprostinil (UT-15C) sustained release tablets; Other: Iloprost (Ventavis inhaled, BAYQ6256); Other: Noninvasive actigraphy monitor; Other: Oxygen Supplementation; Other: Standard-of-care; Other: Standardized meals; Other: Subacute hypoxic exposures; Oxygen; Oxygen supplementation; Oxygen, liquid; PAH; PAH medication; PB1046; PB1046 Subcutaneous Injection; PB1046, VIP-ELP1-120, Vasomera; PF-00489791; PH-combination therapy; PH-monotherapy; PLX-PAD; Parenteral Remodulin (treprostinil) injection; Pemziviptadil (PB1046); Pemziviptadil (PB1046) Injection; Pioglitazone; Placebo; Prednisone; Procedure: B-lines SE; Procedure: Coronary flow reserve SE; Procedure: Diastolic function SE; Procedure: Left ventricular contractile reserve SE; Procedure: Left ventricular outflow tract gradient SE; Procedure: Mitral regurgitation SE; Procedure: NO gas; Procedure: PADN; Procedure: Pulmonary hemodynamics SE; Procedure: sham PADN; Prostacyclin; Puri-Nethol; Q4W GMA301 IV injections (1000 mg); Q4W GMA301 IV injections (300 mg); Q4W GMA301 IV injections (600 mg); QCC374; QCC374 0.015 mg; QCC374 0.06 mg; QTI571; Qutenza; Qutenza (8% capsaicin); RALINEPAG; REVATIO; REVATIO 20 mg, comprimidos recubiertos con película; RIOCIGUAT; RT234 - vardenafil inhalation powder; RTA 402; RVG 33865; RVT-1201; Radiation: PET/CT Scan: Two PET scans using 1. C-11 HED and 2. N-13 Ammonia or rubidium-82; Ralinepag; Ranolazine; Rapamycin; Rapid Dose Titration Group of Subcutaneous Treprostinil; Recombinant Human Angiotensin-Converting Enzyme 2; Recombinant Human Angiotensin-converting enzyme 2 (ACE2), APN01; Remodulin; Remodulin (treprostinil sodium); Remodulin® (treprostinil) 1 mg/ml solution for infusion; Remodulin® (treprostinil) 10 mg/ml solution for infusion; Remodulin® (treprostinil) 2.5 mg/ml solution for infusion; Remodulin® (treprostinil) 5 mg/ml solution for infusion; Revatio; Revatio 10 mg/ml powder for oral suspension; Revatio 20 mg Filmtabletten; Revatio 20 mg film coated tablets; Revatio 20 mg film-coated tablets; Revatio POS; Revatio Tablets; Revatio inyectable; Revatio oral; Revatio ® 20 mg film-coated tablets; Revatio®; Riciguat Group; Rifampin; Riociguat; Riociguat (ADEMPAS, BAY63-2521); Riociguat (Adempas, BAY63-2521); Riociguat (BAY63-2521); Riociguat Oral Product; Riociguat Pill; Riociguat granules 0.3% for oral application; Ritonavir; Rituximab; Ro 47-0203; Ro 47-0203 / ACT-050088; Ro-47-0203; Ro-47-0203/029; Ro47-0203; Ro47-0203 / ACT-050088; RoActemra; Rubidium; SELEXIPAG; SILDENAF; SILDENAFIL; SILDENAFIL CITRATE; SILDENAFILO; SITAXSENTAN SODIUM; SODIUM NITRITE; SOTATERCEPT; STI571; Salbutamol; Saline; Sapropterin; Sapropterin dihydrochloride (6R-BH4); Saquinavir; Saquinavir and ritonavir; Sauerstoff; Selexipag; Selexipag (Uptravi); Selexipag, ACT-293987 (NS-304); Selonsertib; Seralutinib; Serine; Sham O2 (medical air); Sildenafil; Sildenafil (REVATIO); Sildenafil (Revatio) 20 mg TID; Sildenafil (as citrate); Sildenafil 20mg; Sildenafil 20mg and Bosentan 62.5mg; Sildenafil Citrate; Sildenafil Filmtabletten; Sildenafil citrate; Sildenafil citrate (UK-92,480); Sildenafil singly or in association with Bosentan; Sildenafilo; Simvastatin; Simvastatin 40 mg; Simvastatin 40 mg tablets; Sitaxentan; Sitaxentan sodium; Sitaxsentan; Sitaxsentan Sodium; Sitaxsentan alone; Sitaxsentan and Sildenafil; Sitaxsentan sodium; Slow Dose Titration Group of Subcutaneous Treprostinil; Sodium Nitrite Inhalation Solution; Sodium nitrite; Sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth; Sorafenib; Sotatercept; Spironolactone; Spironolactone and conivaptan; Spironolactone captopril carvedilol; Subcutaneous Treprostinil; Subcutaneous and intravenous prostacyclin; Sugar Pill; Sulfasalazine; Sulfate; TADALAFIL; TADALAFILO; TASIGNA; TBD; TPN171H; TRACLEER; TRACLEER 62,5 mg comprimidos recubiertos con película; TRACLEER 62,5MG 56CPR RIV.; TRACLEER*125MG 56CPR RIV.; TRACLEER*56CPR RIV 125MG; TRE; TREPROSTINIL SODIUM; TREPROSTINIL SODIUM, UT-15; TRK-100STP; Tadalafil; Tadalafil 20 mg film-coated tablets; Tadalafil 40 mg; Tadalafil and ambrisentan upfront combination therapy; Tadalafil oral suspension; Tadalafil, Placebo; Tadalafil- Tablet or Oral suspension; Tadalafilo; Tamoxifen; Tasigna; Tasigna®; Tasigna® 150 mg; Tegaderm; Terguride; Terguride 0,5mg tablet; Terguride 0.5 mg tablet; Tezosentan; The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:; The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:; Thelin; Threonine; Thrombin; Tocilizumab; Traclear; Tracleer; Tracleer®; Transdihydrolisuride; Treprosinil Diethanolamine; Treprostin; Treprostinil; Treprostinil Diethanolamine; Treprostinil Diolamine; Treprostinil Inhalation Powder; Treprostinil Injectable Product; Treprostinil Sodium; Treprostinil Sodium Solution for Inhalation; Treprostinil dietanolamina; Treprostinil diethanolamine; Treprostinil inhalations; Treprostinil sodium; Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840; Treprostinilo; Trimetazidine; Tyrosine; Tyvaso; Tyvaso Inhalation Solution; UK 092480; UK-92,480; UK-92,480-10; UT-15C; UT-15C (treprostinil diethanolamine); UT-15C 0.25 mg; UT-15C 1 mg; UT-15C 5 mg; UT-15C LP; UT-15C SR; UT-15C SR (treprostinil diethanolamine); UT-15C-SR; Ubenimex; Udenafil; Uptravi; VIAGRA; VIP; VOLIBRIS; VOLIBRIS 10 mg comprimidos recubiertos con película; VOLIBRIS 5 mg comprimidos recubiertos con película; VOLIBRIS® (ambrisentan); VOLIBRIS™ tablets; Vardenafil; Vasomera (PB1046) Injection; Veletri; Ventavis; Ventavis (Iloprost, BAYQ6256); Ventavis 10; Ventavis(Iloprost); Viagra; Volibris; ZAMICASTAT; Zamicastat; [11C]-GSK2256098 500 MBq; [18F] FES; [18F]Fluoro-2-deoxy-2-D-glucose

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00995566 (ClinicalTrials.gov)	April 2010	17/9/2009	A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin	Thelin (Sitaxentan Sodium) Patient Safety Registry A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin	Pulmonary Arterial Hypertension	Drug: Sitaxentan sodium	Pfizer	NULL	Terminated	18 Years	N/A	All	54	N/A	Belgium;France;Germany;Sweden
2	EUCTR2008-005886-78-CZ (EUCTR)	12/01/2010	10/12/2008	A 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	A 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.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Bulgaria
3	EUCTR2008-005887-14-CZ (EUCTR)	12/01/2010	10/12/2008	A 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	A 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.	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Bulgaria
4	EUCTR2008-005885-30-CZ (EUCTR)	12/01/2010	10/12/2008	A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION	A 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 Ltd	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Bulgaria
5	NCT01445873 (ClinicalTrials.gov)	December 1, 2009	30/9/2011	Pilot 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 Hypertension	Drug: Sitaxentan sodium	Pfizer	NULL	Completed	18 Years	N/A	All	36		NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2008-005885-30-BG (EUCTR)	25/06/2009	19/06/2009	A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION	A 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 10017	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Bulgaria
7	EUCTR2008-005887-14-BG (EUCTR)	25/06/2009	19/06/2009	A 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	A 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, UK	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Bulgaria
8	EUCTR2008-005886-78-BG (EUCTR)	25/06/2009	19/06/2009	A 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	A 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 10017	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Bulgaria
9	EUCTR2008-005886-78-SK (EUCTR)	06/04/2009	20/02/2009	A 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	A 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 UK	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Slovakia;Bulgaria
10	EUCTR2008-005885-30-SK (EUCTR)	06/04/2009	20/02/2009	A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION	A 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 Limited	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Slovakia;Bulgaria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2008-005887-14-SK (EUCTR)	01/04/2009	20/02/2009	A 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	A 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, UK	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 3	Czech Republic;Slovakia;Bulgaria
12	NCT00080457 (ClinicalTrials.gov)	May 2003	1/4/2004	Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension	A 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 Hypertension	Drug: sitaxsentan sodium	Encysive Pharmaceuticals	NULL	Completed	12 Years	75 Years	Both	240	Phase 3	United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT00995566
(ClinicalTrials.gov)

April 2010

17/9/2009

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

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

Pulmonary Arterial Hypertension

Drug: Sitaxentan sodium

Pfizer

NULL

Terminated

18 Years

N/A

All

N/A

Belgium;France;Germany;Sweden

EUCTR2008-005886-78-CZ
(EUCTR)

12/01/2010

10/12/2008

A 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.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Czech Republic;Bulgaria

EUCTR2008-005887-14-CZ
(EUCTR)

12/01/2010

10/12/2008

A 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.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Czech Republic;Bulgaria

EUCTR2008-005885-30-CZ
(EUCTR)

12/01/2010

10/12/2008

A 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 Ltd

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Czech Republic;Bulgaria

NCT01445873
(ClinicalTrials.gov)

December 1, 2009

30/9/2011

Pilot 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 Hypertension

Drug: Sitaxentan sodium

Pfizer

NULL

Completed

18 Years

N/A

All

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2008-005885-30-BG
(EUCTR)

25/06/2009

19/06/2009

A 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 10017

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Czech Republic;Bulgaria

EUCTR2008-005887-14-BG
(EUCTR)

25/06/2009

19/06/2009

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, UK

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Czech Republic;Bulgaria

EUCTR2008-005886-78-BG
(EUCTR)

25/06/2009

19/06/2009

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 10017

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Czech Republic;Bulgaria

EUCTR2008-005886-78-SK
(EUCTR)

06/04/2009

20/02/2009

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 UK

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Czech Republic;Slovakia;Bulgaria

EUCTR2008-005885-30-SK
(EUCTR)

06/04/2009

20/02/2009

A 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 Limited

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Czech Republic;Slovakia;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2008-005887-14-SK
(EUCTR)

01/04/2009

20/02/2009

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, UK

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Czech Republic;Slovakia;Bulgaria

NCT00080457
(ClinicalTrials.gov)

May 2003

1/4/2004

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

A 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 Hypertension

Drug: sitaxsentan sodium

Encysive Pharmaceuticals

NULL

Completed

12 Years

75 Years

Both

240

Phase 3

United States