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	EUCTR2010-021825-11-BG (EUCTR)	02/01/2013	20/11/2012	A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day	An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855 MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 3	Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China
2	EUCTR2011-004106-16-BG (EUCTR)	10/08/2012	11/06/2012	A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound	A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE	Actelion pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	105		United States;Serbia;Portugal;Philippines;Taiwan;Ukraine;Guatemala;Russian Federation;Chile;Colombia;Vietnam;India;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China
3	EUCTR2011-004612-31-PT (EUCTR)	06/07/2012	02/05/2012	A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.	A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE	Actelion pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	105		Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China
4	EUCTR2011-004106-16-PT (EUCTR)	01/06/2012	28/02/2012	A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound	A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE	Actelion pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	105		Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China
5	EUCTR2010-021793-12-NL (EUCTR)	09/11/2011	14/02/2011	A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension	A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension	Pulmonary arterial hypertension (PAH) in children MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		Czech Republic;Hungary;Spain;Germany;Netherlands;Italy
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	EUCTR2010-021825-11-NL (EUCTR)	28/04/2011	03/11/2010	A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day	An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Germany;Netherlands;China
7	EUCTR2010-021793-12-DE (EUCTR)	04/04/2011	01/02/2011	A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a day	A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension	Pulmonary arterial hypertension (PAH) in children MedDRA version: 16.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855 MedDRA version: 16.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;South Africa;Germany;Netherlands;China
8	EUCTR2010-021793-12-CZ (EUCTR)	09/03/2011	04/02/2011	A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a day	A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;South Africa;Netherlands;Germany;China
9	EUCTR2010-021793-12-HU (EUCTR)	28/02/2011	02/02/2011	A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a day	A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension	Pulmonary arterial hypertension (PAH) in children MedDRA version: 16.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855 MedDRA version: 16.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		South Africa;Netherlands;Germany;China;United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia
10	EUCTR2010-021825-11-HU (EUCTR)	08/12/2010	04/11/2010	An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3	An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3	Pulmonary arterial hypertension (PAH) in children MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy
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	EUCTR2010-021825-11-CZ (EUCTR)	03/12/2010	03/12/2010	A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day	An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China
12	EUCTR2010-021825-11-DE (EUCTR)	26/11/2010	08/11/2010	A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day	An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64		Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China
13	EUCTR2005-005068-97-BE (EUCTR)	29/10/2009	10/06/2009	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203 /029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203 /029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 4	Portugal;Czech Republic;Greece;Spain;Belgium;Denmark;Germany;United Kingdom;Sweden
14	EUCTR2005-005068-97-CZ (EUCTR)	16/06/2009	11/06/2009	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203 /029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203 /029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 4	Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
15	EUCTR2005-005068-97-SK (EUCTR)	06/03/2008	06/07/2010	A clinical trial to investigate the safety and effectiveness of the combination of bosentan and sildenafil to treat patients with symptomatic pulmonary arterial hypertension in comparison to treatment with sildenafil on its own	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855 MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203 /029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203 /029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 4	Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;United Kingdom;Czech Republic;Belgium;Brazil;Denmark;Germany;Sweden
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
16	EUCTR2005-005068-97-GB (EUCTR)	30/10/2007	14/06/2007	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 4	Portugal;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Sweden
17	EUCTR2005-005068-97-DK (EUCTR)	12/09/2007	11/05/2007	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 4	Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
18	EUCTR2005-005068-97-SE (EUCTR)	18/06/2007	02/04/2007	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 4	Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
19	EUCTR2004-000745-37-GB (EUCTR)	10/10/2006	23/02/2005	Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension	Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension	Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosis	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	50		Spain;Italy;United Kingdom
20	EUCTR2006-000021-57-DK (EUCTR)	10/03/2006	24/02/2006	Bosentan and Sildenfil for patients with Eisenmenger syndrome	Bosentan and Sildenfil for patients with Eisenmenger syndrome	Eisenmengers syndrome is condition with severe pulmonary arterial hypertension due to a shunting of blood from the left side of the heart to the right side of the heart. When the pressure in the pulmonary arteries levels the systemic blood pressure, blood begins to shunt from the right side of the heart to the left side of the heart leading to a condition with cyanosis, impaired physical capacity and increased mortality (Eisenmengers syndrome).	Trade Name: Tracleer Product Name: Tracleer Other descriptive name: Bosentan monohydrat Trade Name: VIAGRA Product Name: Viagra Other descriptive name: sildenafil	Rigshospitalet	NULL	Not Recruiting			Female: yes Male: yes	20		Denmark
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
21	EUCTR2004-004391-36-CZ (EUCTR)	20/01/2006	05/01/2006	A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension	A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension	Many endothelin receptor antagonists have profound effects on the histology and function of the testes in animals. These drugs have been shown to induce atrophy of the seminiferous tubules of the testes and to reduce sperm counts and male fertility in rats when administered for longer than 10 weeks. Where studied, testicular tubular atrophy and decreases in male fertility observed with endothelin receptor antagonists appear irreversible.	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: no Male: yes	23		Hungary;Czech Republic
22	EUCTR2004-004391-36-HU (EUCTR)	23/05/2005	23/02/2005	A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension	A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension	Many endothelin receptor antagonists have profound effects on the histology and function of the testes in animals. These drugs have been shown to induce atrophy of the seminiferous tubules of the testes and to reduce sperm counts and male fertility in rats when administered for longer than 10 weeks. Where studied, testicular tubular atrophy and decreases in male fertility observed with endothelin receptor antagonists appear irreversible.	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: no Male: yes	23		Hungary;Czech Republic
23	EUCTR2004-000478-30-ES (EUCTR)	10/02/2005	03/11/2004	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.There are no approved drug therapies for Class II PAH and the EARLY study is the first trial designed to enroll exclusively class II patients.	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	170		United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden
24	EUCTR2004-000478-30-BE (EUCTR)	14/12/2004	24/08/2005	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	170		Czech Republic;Spain;Belgium;Denmark;Austria;Italy;United Kingdom;Sweden
25	EUCTR2004-000478-30-AT (EUCTR)	08/12/2004	03/11/2004	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	170		Czech Republic;Spain;Denmark;Austria;Italy;United Kingdom;Sweden
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
26	EUCTR2004-000478-30-CZ (EUCTR)	26/11/2004	26/11/2004	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	170		United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden
27	EUCTR2004-000478-30-SE (EUCTR)	28/10/2004	20/07/2004	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	170		United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden
28	EUCTR2004-000745-37-ES (EUCTR)	11/10/2004	07/10/2004	Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension	Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension	Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosis	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50		United Kingdom;Spain;Italy
29	EUCTR2004-000478-30-DK (EUCTR)	10/09/2004	10/01/2007	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY	Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	170		United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden
30	EUCTR2011-004106-16-NL (EUCTR)		10/02/2012	A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound	A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE	Actelion pharmaceuticals Ltd	NULL	NA			Female: yes Male: yes	105	Phase 3	Portugal;Serbia;United States;Philippines;Guatemala;Ukraine;Russian Federation;Chile;Colombia;India;Vietnam;France;Mexico;Argentina;Croatia;Peru;South Africa;Bulgaria;Netherlands;China
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
31	EUCTR2005-005068-97-DE (EUCTR)		13/02/2006	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2	Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)	Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Viagra INN or Proposed INN: sildenafil (as citrate) Trade Name: Viagra INN or Proposed INN: sildenafil (as citrate) Trade Name: Viagra INN or Proposed INN: sildenafil Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate)	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 4	Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
32	EUCTR2011-004612-31-NL (EUCTR)		07/05/2012	A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.	A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE	Actelion pharmaceuticals Ltd	NULL	NA			Female: yes Male: yes	105	Phase 3	Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China
33	EUCTR2005-001967-70-DE (EUCTR)		30/08/2005	An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2	An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2	Idiopathic or familial pulmonary arterial hypertension	Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	30		United Kingdom;Germany;Italy
34	EUCTR2010-021793-12-PL (EUCTR)		25/07/2011	A 1 year follow-up research project for children with pulmonary arterial hypertension (PAH) that participated in the FUTURE 3 core study. This is to find out how well bosentan is tolerated and safe when taken either two or three times a day	A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 3	Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;South Africa;Netherlands;Germany;China
35	EUCTR2011-004106-16-FR (EUCTR)		17/02/2012	A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound	A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5	Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE	Actelion pharmaceuticals Ltd	NULL	NA			Female: yes Male: yes	105	Phase 3	Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China
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
36	EUCTR2010-021825-11-FR (EUCTR)		13/12/2010	An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3	An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3	Pulmonary arterial hypertension (PAH) in children MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	NA			Female: yes Male: yes	64	Phase 3	France;Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy
37	EUCTR2010-021793-12-FR (EUCTR)		04/02/2011	A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension	A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension	Pulmonary arterial hypertension (PAH) in children MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029	Actelion Pharmaceuticals Ltd.	NULL	NA			Female: yes Male: yes	64	Phase 3	France;Czech Republic;Hungary;Poland;Spain;Netherlands;Germany;Italy
38	EUCTR2011-004612-31-FR (EUCTR)		27/08/2012	A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.	A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6	Pulmonary arterial hypertension (PAH) in children MedDRA version: 15.0;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 15.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE	Actelion pharmaceuticals Ltd	NULL	NA			Female: yes Male: yes	105	Phase 3	Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China

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

EUCTR2010-021825-11-BG
(EUCTR)

02/01/2013

20/11/2012

A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day

An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3

Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China

EUCTR2011-004106-16-BG
(EUCTR)

10/08/2012

11/06/2012

A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound

A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5

Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE

Actelion pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

105

United States;Serbia;Portugal;Philippines;Taiwan;Ukraine;Guatemala;Russian Federation;Chile;Colombia;Vietnam;India;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China

EUCTR2011-004612-31-PT
(EUCTR)

06/07/2012

02/05/2012

A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.

A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE

Actelion pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

105

Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China

EUCTR2011-004106-16-PT
(EUCTR)

01/06/2012

28/02/2012

Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE

Actelion pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

105

EUCTR2010-021793-12-NL
(EUCTR)

09/11/2011

14/02/2011

A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension

Pulmonary arterial hypertension (PAH) in children
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Czech Republic;Hungary;Spain;Germany;Netherlands;Italy

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

EUCTR2010-021825-11-NL
(EUCTR)

28/04/2011

03/11/2010

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Germany;Netherlands;China

EUCTR2010-021793-12-DE
(EUCTR)

04/04/2011

01/02/2011

A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a day

A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension

Pulmonary arterial hypertension (PAH) in children
MedDRA version: 16.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855
MedDRA version: 16.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;South Africa;Germany;Netherlands;China

EUCTR2010-021793-12-CZ
(EUCTR)

09/03/2011

04/02/2011

A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension

Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;South Africa;Netherlands;Germany;China

EUCTR2010-021793-12-HU
(EUCTR)

28/02/2011

02/02/2011

A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

South Africa;Netherlands;Germany;China;United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia

EUCTR2010-021825-11-HU
(EUCTR)

08/12/2010

04/11/2010

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy

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

EUCTR2010-021825-11-CZ
(EUCTR)

03/12/2010

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China

EUCTR2010-021825-11-DE
(EUCTR)

26/11/2010

08/11/2010

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China

EUCTR2005-005068-97-BE
(EUCTR)

29/10/2009

10/06/2009

Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2

Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)

Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203 /029
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203 /029

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 4

Portugal;Czech Republic;Greece;Spain;Belgium;Denmark;Germany;United Kingdom;Sweden

EUCTR2005-005068-97-CZ
(EUCTR)

16/06/2009

11/06/2009

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 4

Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden

EUCTR2005-005068-97-SK
(EUCTR)

06/03/2008

06/07/2010

A clinical trial to investigate the safety and effectiveness of the combination of bosentan and sildenafil to treat patients with symptomatic pulmonary arterial hypertension in comparison to treatment with sildenafil on its own

Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 4

Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;United Kingdom;Czech Republic;Belgium;Brazil;Denmark;Germany;Sweden

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

EUCTR2005-005068-97-GB
(EUCTR)

30/10/2007

14/06/2007

Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 4

Portugal;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Sweden

EUCTR2005-005068-97-DK
(EUCTR)

12/09/2007

11/05/2007

Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 4

Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden

EUCTR2005-005068-97-SE
(EUCTR)

18/06/2007

02/04/2007

Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 4

Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden

EUCTR2004-000745-37-GB
(EUCTR)

10/10/2006

23/02/2005

Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension

Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosis

Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Spain;Italy;United Kingdom

EUCTR2006-000021-57-DK
(EUCTR)

10/03/2006

24/02/2006

Bosentan and Sildenfil for patients with Eisenmenger syndrome

Eisenmengers syndrome is condition with severe pulmonary arterial hypertension due to a shunting of blood from the left side of the heart to the right side of the heart. When the pressure in the pulmonary arteries levels the systemic blood pressure, blood begins to shunt from the right side of the heart to the left side of the heart leading to a condition with cyanosis, impaired physical capacity and increased mortality (Eisenmengers syndrome).

Trade Name: Tracleer
Product Name: Tracleer
Other descriptive name: Bosentan monohydrat
Trade Name: VIAGRA
Product Name: Viagra
Other descriptive name: sildenafil

Rigshospitalet

NULL

Not Recruiting

Female: yes
Male: yes

Denmark

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

EUCTR2004-004391-36-CZ
(EUCTR)

20/01/2006

05/01/2006

A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension

Many endothelin receptor antagonists have profound effects on the histology and function of the testes in animals. These drugs have been shown to induce atrophy of the seminiferous tubules of the testes and to reduce sperm counts and male fertility in rats when administered for longer than 10 weeks. Where studied, testicular tubular atrophy and decreases in male fertility observed with endothelin receptor antagonists appear irreversible.

Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: no
Male: yes

Hungary;Czech Republic

EUCTR2004-004391-36-HU
(EUCTR)

23/05/2005

23/02/2005

A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension

Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: no
Male: yes

Hungary;Czech Republic

EUCTR2004-000478-30-ES
(EUCTR)

10/02/2005

03/11/2004

Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY

Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.There are no approved drug therapies for Class II PAH and the EARLY study is the first trial designed to enroll exclusively class II patients.

Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

170

United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden

EUCTR2004-000478-30-BE
(EUCTR)

14/12/2004

24/08/2005

Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

170

Czech Republic;Spain;Belgium;Denmark;Austria;Italy;United Kingdom;Sweden

EUCTR2004-000478-30-AT
(EUCTR)

08/12/2004

03/11/2004

Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

170

Czech Republic;Spain;Denmark;Austria;Italy;United Kingdom;Sweden

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

EUCTR2004-000478-30-CZ
(EUCTR)

26/11/2004

Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

170

United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden

EUCTR2004-000478-30-SE
(EUCTR)

28/10/2004

20/07/2004

Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

170

United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden

EUCTR2004-000745-37-ES
(EUCTR)

11/10/2004

07/10/2004

Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Spain;Italy

EUCTR2004-000478-30-DK
(EUCTR)

10/09/2004

10/01/2007

Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

170

United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden

EUCTR2011-004106-16-NL
(EUCTR)

10/02/2012

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE

Actelion pharmaceuticals Ltd

NULL

Female: yes
Male: yes

105

Phase 3

Portugal;Serbia;United States;Philippines;Guatemala;Ukraine;Russian Federation;Chile;Colombia;India;Vietnam;France;Mexico;Argentina;Croatia;Peru;South Africa;Bulgaria;Netherlands;China

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

EUCTR2005-005068-97-DE
(EUCTR)

13/02/2006

Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)

Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
Trade Name: Viagra
INN or Proposed INN: sildenafil (as citrate)
Trade Name: Viagra
INN or Proposed INN: sildenafil (as citrate)
Trade Name: Viagra
INN or Proposed INN: sildenafil
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 4

Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden

EUCTR2011-004612-31-NL
(EUCTR)

07/05/2012

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE

Actelion pharmaceuticals Ltd

NULL

Female: yes
Male: yes

105

Phase 3

EUCTR2005-001967-70-DE
(EUCTR)

30/08/2005

An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2

Idiopathic or familial pulmonary arterial hypertension

Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Germany;Italy

EUCTR2010-021793-12-PL
(EUCTR)

25/07/2011

A 1 year follow-up research project for children with pulmonary arterial hypertension (PAH) that participated in the FUTURE 3 core study. This is to find out how well bosentan is tolerated and safe when taken either two or three times a day

A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;South Africa;Netherlands;Germany;China

EUCTR2011-004106-16-FR
(EUCTR)

17/02/2012

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE

Actelion pharmaceuticals Ltd

NULL

Female: yes
Male: yes

105

Phase 3

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

EUCTR2010-021825-11-FR
(EUCTR)

13/12/2010

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029

Actelion Pharmaceuticals Ltd.

NULL

Female: yes
Male: yes

Phase 3

France;Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy

EUCTR2010-021793-12-FR
(EUCTR)

04/02/2011

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029

Actelion Pharmaceuticals Ltd.

NULL

Female: yes
Male: yes

Phase 3

France;Czech Republic;Hungary;Poland;Spain;Netherlands;Germany;Italy

EUCTR2011-004612-31-FR
(EUCTR)

27/08/2012

Pulmonary arterial hypertension (PAH) in children
MedDRA version: 15.0;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 15.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE

Actelion pharmaceuticals Ltd

NULL

Female: yes
Male: yes

105

Phase 3