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	EUCTR2019-004783-22-NL (EUCTR)	03/12/2020	30/06/2020	A clinical trial to study the effects of selexipag on the heart in patients with Pulmonary Arterial Hypertension	A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging - RESTORE	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG	ACTELION Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 4	United States;United Arab Emirates;Hong Kong;Saudi Arabia;Israel;Russian Federation;United Kingdom;France;Argentina;Brazil;Netherlands;Germany;China;Korea, Republic of
2	EUCTR2019-004783-22-GB (EUCTR)	16/11/2020	26/08/2020	A clinical trial to study the effects of selexipag on the heart in patients with Pulmonary Arterial Hypertension	A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging - RESTORE	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Uptravi Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Uptravi Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Uptravi Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Uptravi Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Uptravi Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG Trade Name: Uptravi Product Name: Uptravi Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Other descriptive name: SELEXIPAG	ACTELION Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	80	Phase 4	United States;United Arab Emirates;Hong Kong;Saudi Arabia;Israel;Russian Federation;United Kingdom;France;Argentina;Brazil;Germany;Netherlands;China;Korea, Republic of
3	EUCTR2019-002817-21-LT (EUCTR)	13/08/2020	25/05/2020	A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.	A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	237	Phase 3	Bulgaria;Germany;Sweden;United States;Serbia;Belarus;Portugal;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania
4	EUCTR2019-002817-21-PT (EUCTR)	27/07/2020	06/02/2020	A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.	A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged greater or equal than 2 to under 18 years with Pulmonary Arterial Hypertension. - SALTO	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	237	Phase 3	Serbia;United States;Portugal;Belarus;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden
5	EUCTR2019-002817-21-DE (EUCTR)	16/04/2020	30/10/2019	A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.	A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	237	Phase 3	United States;Serbia;Belarus;Portugal;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;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
6	EUCTR2019-002817-21-BG (EUCTR)	11/02/2020	06/01/2020	A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.	A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	237	Phase 3	United States;Serbia;Belarus;Portugal;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
7	EUCTR2019-002817-21-HU (EUCTR)	05/02/2020	29/11/2019	A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.	A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	237	Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden
8	EUCTR2018-000145-39-DE (EUCTR)	25/10/2018	05/06/2018	A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension	A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Malaysia;Singapore;Romania;Netherlands;Germany;China
9	EUCTR2018-000145-39-GB (EUCTR)	22/10/2018	28/03/2018	A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension	A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	United States;Serbia;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Malaysia;Poland;Singapore;Romania;Germany;Netherlands;China
10	EUCTR2017-000216-42-FR (EUCTR)	27/09/2018	23/07/2018	Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag	A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	United States;Portugal;France;Ireland;Austria;Norway;Germany;United Kingdom;Switzerland;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
11	EUCTR2018-000145-39-HU (EUCTR)	03/07/2018	18/07/2018	A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension	A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	55	Phase 2	Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Malaysia;Singapore;Romania;Netherlands;Germany;China
12	EUCTR2015-003438-28-GB (EUCTR)	21/06/2018	13/11/2017	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	238	Phase 3	United States;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Sweden
13	EUCTR2017-000216-42-PT (EUCTR)	14/05/2018	03/11/2017	Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag	A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	United States;France;Portugal;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
14	EUCTR2015-003438-28-ES (EUCTR)	19/01/2018	01/12/2017	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL	Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	238	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Sweden
15	EUCTR2017-000216-42-DE (EUCTR)	30/11/2017	26/05/2017	Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag	A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;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	EUCTR2017-000216-42-SE (EUCTR)	24/10/2017	16/05/2017	Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag	A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
17	EUCTR2017-000216-42-IE (EUCTR)	12/09/2017	05/05/2017	Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag	A multi-center, double-blind, placebo-controlled, Phase 3b study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
18	EUCTR2017-000216-42-AT (EUCTR)	29/08/2017	09/06/2017	Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag	A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
19	EUCTR2017-000216-42-GB (EUCTR)	11/07/2017	05/05/2017	Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag	A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;Switzerland;United Kingdom;Sweden
20	EUCTR2015-003438-28-DK (EUCTR)	17/08/2016	30/05/2016	The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension	The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	238	Phase 3	United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;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
21	EUCTR2015-003438-28-FR (EUCTR)	20/06/2016	21/04/2016	The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension	The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON	Pulmonary arterial hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: Tadalafil Other descriptive name: TADALAFIL	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	144	Phase 3	United States;Spain;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
22	EUCTR2015-003438-28-DE (EUCTR)	04/03/2016	19/01/2016	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH	Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	238	Phase 3	United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
23	EUCTR2015-003438-28-BE (EUCTR)	03/03/2016	09/06/2020	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH	Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	238	Phase 3	United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
24	EUCTR2015-003438-28-AT (EUCTR)	12/01/2016	25/07/2017	The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension	The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: Tadalafil Other descriptive name: TADALAFIL	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	238	Phase 3	United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
25	EUCTR2009-014992-31-GB (EUCTR)	28/10/2013	17/03/2010	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;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
26	EUCTR2009-014490-41-NL (EUCTR)	16/02/2011	18/02/2011	Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Peru;Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
27	EUCTR2009-014992-31-NL (EUCTR)	16/02/2011	18/02/2011	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
28	EUCTR2009-014490-41-SK (EUCTR)	09/02/2011	09/06/2010	A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON	A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-293987 Product Code: ACT-293987	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	670	Phase 3	Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden
29	EUCTR2009-014992-31-SK (EUCTR)	09/02/2011	09/06/2010	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	670		Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
30	EUCTR2009-014490-41-IE (EUCTR)	15/11/2010	14/04/2010	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;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
31	EUCTR2009-014992-31-GR (EUCTR)	09/11/2010	09/11/2010	Long-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON OL	Long-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension		Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	670	Phase 3	Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Slovakia;Greece;Spain;Ireland;Austria;Poland;Denmark;Netherlands;Germany;Sweden
32	EUCTR2009-014490-41-GR (EUCTR)	11/10/2010	04/10/2010	A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON	A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-293987 Product Code: ACT-293987	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	670	Phase 3	Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden
33	EUCTR2009-014490-41-DE (EUCTR)	24/08/2010	10/06/2010	Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
34	EUCTR2009-014992-31-DE (EUCTR)	24/08/2010	08/06/2010	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden
35	EUCTR2009-014992-31-CZ (EUCTR)	20/08/2010	19/08/2010	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;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
36	EUCTR2009-014490-41-IT (EUCTR)	06/08/2010	28/12/2011	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension	A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate the efficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	670	Phase 3	Belarus;United States;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Singapore;Germany;Sweden
37	EUCTR2009-014992-31-IT (EUCTR)	06/08/2010	28/12/2011	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term, single-arm, open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON-OL	Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	670		Germany;Malaysia;France;Ireland;Singapore;Austria;Australia;Sweden;Czech Republic;Canada;Belarus;Peru;Belgium;Korea, Republic of;Greece;United States;Hungary;Turkey;Switzerland;Netherlands;Chile;Italy;Israel;India;Slovakia;Russian Federation;Ukraine;Denmark;Argentina;Taiwan;Mexico;China;Thailand;Spain
38	EUCTR2009-014992-31-AT (EUCTR)	28/07/2010	28/05/2010	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Uptravi Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
39	EUCTR2009-014490-41-AT (EUCTR)	28/07/2010	28/05/2010	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessing the safety and efficacy of selexipag on morbidity and mortality in patients with pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
40	EUCTR2009-014490-41-HU (EUCTR)	27/07/2010	18/05/2010	Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;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
41	EUCTR2009-014992-31-HU (EUCTR)	27/07/2010	01/06/2010	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1150		Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
42	NCT01112306 (ClinicalTrials.gov)	July 7, 2010	8/4/2010	ACT-293987 in Pulmonary Arterial Hypertension	Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of ACT-293987 in Patients With Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: ACT-293987	Actelion	NULL	Active, not recruiting	18 Years	N/A	All	1187	Phase 3	United States;Argentina;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Colombia;Czechia;Denmark;France;Germany;Greece;Hungary;India;Ireland;Israel;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Czech Republic;Italy
43	EUCTR2009-014490-41-GB (EUCTR)	23/03/2010	17/03/2010	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
44	EUCTR2009-014490-41-BE (EUCTR)	22/02/2010	23/11/2009	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 15.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
45	EUCTR2009-014992-31-BE (EUCTR)	22/02/2010	23/11/2009	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1150		Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;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
46	EUCTR2009-014490-41-CZ (EUCTR)	19/02/2010	19/02/2010	Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
47	EUCTR2009-014490-41-FR (EUCTR)	12/02/2010	26/11/2009	A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON 2	A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON 2	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-293987 Product Code: ACT-293987	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	272	Phase 3	Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden
48	EUCTR2009-014490-41-SE (EUCTR)	06/02/2010	14/12/2009	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden;Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of
49	EUCTR2009-014992-31-SE (EUCTR)	06/02/2010	14/12/2009	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
50	EUCTR2009-014992-31-DK (EUCTR)	05/02/2010	17/12/2009	Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension	Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;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
51	EUCTR2009-014992-31-FR (EUCTR)	27/01/2010	26/11/2009	Long-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON OL	Long-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON OL	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension		Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	544	Phase 3	Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Denmark;Netherlands;Germany;Sweden
52	EUCTR2009-014490-41-ES (EUCTR)	22/01/2010	02/12/2009	Estudio en fase III, multicéntrico, a doble ciego y controlado con placebo, para demostrar la eficacia y seguridad de ACT-293987 en pacientes con hipertensión arterial pulmonar (PAH) - GRIPHON 2	Estudio en fase III, multicéntrico, a doble ciego y controlado con placebo, para demostrar la eficacia y seguridad de ACT-293987 en pacientes con hipertensión arterial pulmonar (PAH) - GRIPHON 2	Hipertensión Arterial Pulmonar MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-293987 Product Code: ACT-293987	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	272		Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden
53	EUCTR2009-014992-31-ES (EUCTR)	22/01/2010	02/12/2009	Estudio de extensión abierta, de grupo único de tratamiento y a largo plazo, para evaluar la seguridad y tolerabilidad de ACT-293987 en pacientes con hipertensión arterial pulmonar - GRIPHON OL	Estudio de extensión abierta, de grupo único de tratamiento y a largo plazo, para evaluar la seguridad y tolerabilidad de ACT-293987 en pacientes con hipertensión arterial pulmonar - GRIPHON OL	Hipertensión Arterial Pulmonar MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: ACT-293987 Product Code: ACT-293987	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	544	Phase 3	Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Denmark;Netherlands;Germany;Sweden
54	EUCTR2009-014490-41-DK (EUCTR)	08/12/2009	23/11/2009	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.	A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON	The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: ACT-293987 Product Code: ACT-293987 INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	1150	Phase 3	Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden
55	NCT01106014 (ClinicalTrials.gov)	December 2009	2/4/2010	Selexipag (ACT-293987) in Pulmonary Arterial Hypertension	A Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: Selexipag;Drug: Placebo	Actelion	NULL	Completed	18 Years	75 Years	All	1156	Phase 3	United States;Argentina;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Colombia;Czech Republic;Denmark;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom
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
56	EUCTR2007-006453-12-AT (EUCTR)	19/03/2009	23/06/2008	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension	A multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS 304/-02)	Pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: Selexipag , ACT-293987 (NS-304) INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
57	EUCTR2007-003328-39-GB (EUCTR)	05/11/2008	19/03/2008	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Code: ACT-293987 (NS-304) INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	44		Hungary;Germany;United Kingdom;Belgium;France;Italy;Austria
58	EUCTR2007-006453-12-BE (EUCTR)	03/10/2008	07/07/2008	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension	A multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT 293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS 304/-02)	pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: Selexipag , ACT-293987 (NS-304) INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
59	EUCTR2007-006453-12-DE (EUCTR)	12/09/2008	19/12/2008	Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension	A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02)	Pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Code: Selexipag , ACT-293987 (NS-304) INN or Proposed INN: Selexipag	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
60	EUCTR2007-006453-12-GB (EUCTR)	31/07/2008	15/07/2008	A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02)	A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02)	pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrcted congenital vitium or anorexigen MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension		Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom
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
61	EUCTR2007-003328-39-HU (EUCTR)	25/04/2008	18/01/2008	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Code: ACT-293987 (NS-304) INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	44		Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria
62	EUCTR2007-003328-39-BE (EUCTR)	25/04/2008	27/11/2007	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Code: ACT-293987 (NS-304) INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	44		Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria
63	EUCTR2007-003328-39-DE (EUCTR)	13/02/2008	07/12/2007	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over	pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Code: ACT-293987 (NS-304) INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	44		Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria
64	EUCTR2015-003438-28-NO (EUCTR)		09/03/2016	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension	The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON	Pulmonary arterial hypertension (PAH) MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: Tadalafil Other descriptive name: TADALAFIL	Actelion Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	144	Phase 3	United States;Austria;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden
65	EUCTR2019-002817-21-BE (EUCTR)		02/12/2019	A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.	A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd.	NULL	NA			Female: yes Male: yes	237	Phase 3	United States;Serbia;Belarus;Portugal;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;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
66	EUCTR2018-000145-39-PL (EUCTR)		02/04/2019	A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension	A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension	Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	55	Phase 2	Canada;Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;Italy;United Kingdom;Vietnam;France;Hungary;Malaysia;Poland;Singapore;Romania;Netherlands;Germany;China
67	EUCTR2019-002817-21-PL (EUCTR)		15/10/2019	A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.	A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd.	NULL	NA			Female: yes Male: yes	237	Phase 3	United States;Belarus;Portugal;Serbia;Taiwan;Thailand;Spain;Ukraine;Israel;Russian Federation;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
68	EUCTR2019-002817-21-SE (EUCTR)		29/10/2019	A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.	A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO	Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: JNJ-67896049 (ACT-293987) INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd.	NULL	NA			Female: yes Male: yes	237	Phase 3	United States;Serbia;Belarus;Portugal;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
69	EUCTR2018-000145-39-FR (EUCTR)		26/04/2018	A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension	A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension	Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG	Actelion Pharmaceuticals Ltd	NULL	NA			Female: yes Male: yes	55	Phase 2	Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Malaysia;Singapore;Romania;Netherlands;Germany;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

EUCTR2019-004783-22-NL
(EUCTR)

03/12/2020

30/06/2020

A clinical trial to study the effects of selexipag on the heart in patients with Pulmonary Arterial Hypertension

A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging - RESTORE

Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG

ACTELION Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

United States;United Arab Emirates;Hong Kong;Saudi Arabia;Israel;Russian Federation;United Kingdom;France;Argentina;Brazil;Netherlands;Germany;China;Korea, Republic of

EUCTR2019-004783-22-GB
(EUCTR)

16/11/2020

26/08/2020

A clinical trial to study the effects of selexipag on the heart in patients with Pulmonary Arterial Hypertension

Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG
Trade Name: Uptravi
Product Name: Uptravi
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Other descriptive name: SELEXIPAG

ACTELION Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

United States;United Arab Emirates;Hong Kong;Saudi Arabia;Israel;Russian Federation;United Kingdom;France;Argentina;Brazil;Germany;Netherlands;China;Korea, Republic of

EUCTR2019-002817-21-LT
(EUCTR)

13/08/2020

25/05/2020

A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged =2 to <18 years with Pulmonary Arterial Hypertension. - SALTO

Trade Name: Uptravi
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: JNJ-67896049 (ACT-293987)
INN or Proposed INN: SELEXIPAG

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

237

Phase 3

Bulgaria;Germany;Sweden;United States;Serbia;Belarus;Portugal;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania

EUCTR2019-002817-21-PT
(EUCTR)

27/07/2020

06/02/2020

A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Event-Driven, Group-Sequential Study with Open-Label Extension Period to Assess the Efficacy and Safety of Selexipag as Add-On Treatment to Standard of Care in Children Aged greater or equal than 2 to under 18 years with Pulmonary Arterial Hypertension. - SALTO

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

237

Phase 3

Serbia;United States;Portugal;Belarus;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden

EUCTR2019-002817-21-DE
(EUCTR)

16/04/2020

30/10/2019

A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

237

Phase 3

United States;Serbia;Belarus;Portugal;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;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

EUCTR2019-002817-21-BG
(EUCTR)

11/02/2020

06/01/2020

A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

237

Phase 3

EUCTR2019-002817-21-HU
(EUCTR)

05/02/2020

29/11/2019

A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

237

Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Switzerland;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden

EUCTR2018-000145-39-DE
(EUCTR)

25/10/2018

05/06/2018

A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension

A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension

Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Malaysia;Singapore;Romania;Netherlands;Germany;China

EUCTR2018-000145-39-GB
(EUCTR)

22/10/2018

28/03/2018

A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension

A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension

Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Serbia;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Malaysia;Poland;Singapore;Romania;Germany;Netherlands;China

EUCTR2017-000216-42-FR
(EUCTR)

27/09/2018

23/07/2018

Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag

A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE

Pulmonary arterial hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

United States;Portugal;France;Ireland;Austria;Norway;Germany;United Kingdom;Switzerland;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

EUCTR2018-000145-39-HU
(EUCTR)

03/07/2018

18/07/2018

A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension

A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Malaysia;Singapore;Romania;Netherlands;Germany;China

EUCTR2015-003438-28-GB
(EUCTR)

21/06/2018

13/11/2017

The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension

The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH

Pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

238

Phase 3

United States;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Sweden

EUCTR2017-000216-42-PT
(EUCTR)

14/05/2018

03/11/2017

Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag

Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

United States;France;Portugal;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden

EUCTR2015-003438-28-ES
(EUCTR)

19/01/2018

01/12/2017

The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension

Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

238

Phase 3

United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Sweden

EUCTR2017-000216-42-DE
(EUCTR)

30/11/2017

26/05/2017

Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag

Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;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

EUCTR2017-000216-42-SE
(EUCTR)

24/10/2017

16/05/2017

Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag

Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden

EUCTR2017-000216-42-IE
(EUCTR)

12/09/2017

05/05/2017

Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag

A multi-center, double-blind, placebo-controlled, Phase 3b study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE

Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden

EUCTR2017-000216-42-AT
(EUCTR)

29/08/2017

09/06/2017

Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag

Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

United States;Portugal;France;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden

EUCTR2017-000216-42-GB
(EUCTR)

11/07/2017

05/05/2017

Daily life physical activity and disease symptoms assessed in patients withpulmonary arterial hypertension (PAH) treated with selexipag

Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;Switzerland;United Kingdom;Sweden

EUCTR2015-003438-28-DK
(EUCTR)

17/08/2016

30/05/2016

The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension

The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

238

Phase 3

United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;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

EUCTR2015-003438-28-FR
(EUCTR)

20/06/2016

21/04/2016

The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension

The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON

Pulmonary arterial hypertension (PAH)
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

144

Phase 3

United States;Spain;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden

EUCTR2015-003438-28-DE
(EUCTR)

04/03/2016

19/01/2016

The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension

Pulmonary arterial hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

238

Phase 3

United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden

EUCTR2015-003438-28-BE
(EUCTR)

03/03/2016

09/06/2020

The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

238

Phase 3

United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden

EUCTR2015-003438-28-AT
(EUCTR)

12/01/2016

25/07/2017

The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension

The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

238

Phase 3

United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden

EUCTR2009-014992-31-GB
(EUCTR)

28/10/2013

17/03/2010

Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension

Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL

The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;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

EUCTR2009-014490-41-NL
(EUCTR)

16/02/2011

18/02/2011

Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.

A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON

The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1150

Phase 3

Peru;Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden

EUCTR2009-014992-31-NL
(EUCTR)

16/02/2011

18/02/2011

Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension

Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL

Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden

EUCTR2009-014490-41-SK
(EUCTR)

09/02/2011

09/06/2010

A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON

The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Product Name: ACT-293987
Product Code: ACT-293987

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

670

Phase 3

Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden

EUCTR2009-014992-31-SK
(EUCTR)

09/02/2011

09/06/2010

Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension

Long-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON OL

The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

670

Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden

EUCTR2009-014490-41-IE
(EUCTR)

15/11/2010

14/04/2010

Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.

A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON

The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1150

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

EUCTR2009-014992-31-GR
(EUCTR)

09/11/2010

Long-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON OL

The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

670

Phase 3

Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Slovakia;Greece;Spain;Ireland;Austria;Poland;Denmark;Netherlands;Germany;Sweden

EUCTR2009-014490-41-GR
(EUCTR)

11/10/2010

04/10/2010

A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON

The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Product Name: ACT-293987
Product Code: ACT-293987

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

670

Phase 3

Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden

EUCTR2009-014490-41-DE
(EUCTR)

24/08/2010

10/06/2010

Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.

A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON

Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1150

Phase 3

EUCTR2009-014992-31-DE
(EUCTR)

24/08/2010

08/06/2010

Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension

Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL

Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1150

Phase 3

United States;Serbia;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Peru;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Germany;Sweden

EUCTR2009-014992-31-CZ
(EUCTR)

20/08/2010

19/08/2010

Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension

Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL

The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Trade Name: Uptravi
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1150

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

EUCTR2009-014490-41-IT
(EUCTR)

06/08/2010

28/12/2011

Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension

A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate the efficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON

Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

670

Phase 3

Belarus;United States;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Singapore;Germany;Sweden

EUCTR2009-014992-31-IT
(EUCTR)

06/08/2010

28/12/2011

Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension

Long-term, single-arm, open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON-OL

Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

670

Germany;Malaysia;France;Ireland;Singapore;Austria;Australia;Sweden;Czech Republic;Canada;Belarus;Peru;Belgium;Korea, Republic of;Greece;United States;Hungary;Turkey;Switzerland;Netherlands;Chile;Italy;Israel;India;Slovakia;Russian Federation;Ukraine;Denmark;Argentina;Taiwan;Mexico;China;Thailand;Spain

EUCTR2009-014992-31-AT
(EUCTR)

28/07/2010

28/05/2010

Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension

Long-term single-arm open-label study, to assess the safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension - GRIPHON OL

The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Trade Name: Uptravi
Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1150

Phase 3

EUCTR2009-014490-41-AT
(EUCTR)

28/07/2010

28/05/2010

Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.

A multicenter, double-blind, placebo-controlled Phase 3 study assessing the safety and efficacy of selexipag on morbidity and mortality in patients with pulmonary arterial hypertension - GRIPHON

Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1150

Phase 3

EUCTR2009-014490-41-HU
(EUCTR)

27/07/2010

18/05/2010

Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.

A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON

Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1150

Phase 3

Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;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

EUCTR2009-014992-31-HU
(EUCTR)

27/07/2010

01/06/2010

Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension

Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL

The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden

NCT01112306
(ClinicalTrials.gov)

July 7, 2010

8/4/2010

ACT-293987 in Pulmonary Arterial Hypertension

Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of ACT-293987 in Patients With Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension

Drug: ACT-293987

Actelion

NULL

Active, not recruiting

18 Years

N/A

All

1187

Phase 3

United States;Argentina;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Colombia;Czechia;Denmark;France;Germany;Greece;Hungary;India;Ireland;Israel;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Czech Republic;Italy

EUCTR2009-014490-41-GB
(EUCTR)

23/03/2010

17/03/2010

Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.

A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON

Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1150

Phase 3

EUCTR2009-014490-41-BE
(EUCTR)

22/02/2010

23/11/2009

Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.

A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON

The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 15.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1150

Phase 3

EUCTR2009-014992-31-BE
(EUCTR)

22/02/2010

23/11/2009

Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension

Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL

Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

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

EUCTR2009-014490-41-CZ
(EUCTR)

19/02/2010

Study to evaluate if selexipag is safe and efficacious for the treatment ofpulmonary arterial hypertension.

A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON

Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1150

Phase 3

EUCTR2009-014490-41-FR
(EUCTR)

12/02/2010

26/11/2009

A multicenter, double-blind, placebo-controlled Phase 3 study to demonstrate theefficacy and safety of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON 2

The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Product Name: ACT-293987
Product Code: ACT-293987

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

272

Phase 3

Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden

EUCTR2009-014490-41-SE
(EUCTR)

06/02/2010

14/12/2009

Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.

A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON

Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1150

Phase 3

Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden;Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Denmark;Peru;Australia;Netherlands;China;Korea, Republic of

EUCTR2009-014992-31-SE
(EUCTR)

06/02/2010

14/12/2009

Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension

Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL

Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1150

Phase 3

EUCTR2009-014992-31-DK
(EUCTR)

05/02/2010

17/12/2009

Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension

Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL

Product Name: selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1150

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

EUCTR2009-014992-31-FR
(EUCTR)

27/01/2010

26/11/2009

Long-term single-arm open-label study, to assess the safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension - GRIPHON OL

The intended indication is Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

544

Phase 3

Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Denmark;Netherlands;Germany;Sweden

EUCTR2009-014490-41-ES
(EUCTR)

22/01/2010

02/12/2009

Estudio en fase III, multicéntrico, a doble ciego y controlado con placebo, para demostrar la eficacia y seguridad de ACT-293987 en pacientes con hipertensión arterial pulmonar (PAH) - GRIPHON 2

Hipertensión Arterial Pulmonar
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Product Name: ACT-293987
Product Code: ACT-293987

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

272

Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Netherlands;Germany;Sweden

EUCTR2009-014992-31-ES
(EUCTR)

22/01/2010

02/12/2009

Estudio de extensión abierta, de grupo único de tratamiento y a largo plazo, para evaluar la seguridad y tolerabilidad de ACT-293987 en pacientes con hipertensión arterial pulmonar - GRIPHON OL

Hipertensión Arterial Pulmonar
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Product Name: ACT-293987
Product Code: ACT-293987

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

544

Phase 3

Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Poland;Denmark;Netherlands;Germany;Sweden

EUCTR2009-014490-41-DK
(EUCTR)

08/12/2009

23/11/2009

Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension.

A multicenter, double-blind, placebo-controlled Phase 3 study assessingthe safety and efficacy of selexipag on morbidity and mortality in patientswith pulmonary arterial hypertension - GRIPHON

Product Name: ACT-293987
Product Code: ACT-293987
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1150

Phase 3

Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden

NCT01106014
(ClinicalTrials.gov)

December 2009

2/4/2010

Selexipag (ACT-293987) in Pulmonary Arterial Hypertension

A Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension

Drug: Selexipag;Drug: Placebo

Actelion

NULL

Completed

18 Years

75 Years

All

1156

Phase 3

United States;Argentina;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Colombia;Czech Republic;Denmark;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom

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

EUCTR2007-006453-12-AT
(EUCTR)

19/03/2009

23/06/2008

Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension

A multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS 304/-02)

Pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use
MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Code: Selexipag , ACT-293987 (NS-304)
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom

EUCTR2007-003328-39-GB
(EUCTR)

05/11/2008

19/03/2008

A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over

pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use)
MedDRA version: 9.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension

Product Code: ACT-293987 (NS-304)
INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Germany;United Kingdom;Belgium;France;Italy;Austria

EUCTR2007-006453-12-BE
(EUCTR)

03/10/2008

07/07/2008

Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension

A multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT 293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS 304/-02)

pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use
MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Code: Selexipag , ACT-293987 (NS-304)
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom

EUCTR2007-006453-12-DE
(EUCTR)

12/09/2008

19/12/2008

Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension

A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of selexipag / ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02)

Pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use
MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Code: Selexipag , ACT-293987 (NS-304)
INN or Proposed INN: Selexipag

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom

EUCTR2007-006453-12-GB
(EUCTR)

31/07/2008

15/07/2008

A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02)

pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrcted congenital vitium or anorexigen
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Belgium;Austria;Germany;Italy;United Kingdom

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

EUCTR2007-003328-39-HU
(EUCTR)

25/04/2008

18/01/2008

Product Code: ACT-293987 (NS-304)
INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria

EUCTR2007-003328-39-BE
(EUCTR)

25/04/2008

27/11/2007

Product Code: ACT-293987 (NS-304)
INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria

EUCTR2007-003328-39-DE
(EUCTR)

13/02/2008

07/12/2007

Product Code: ACT-293987 (NS-304)
INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria

EUCTR2015-003438-28-NO
(EUCTR)

09/03/2016

The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension

Pulmonary arterial hypertension (PAH)
MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Actelion Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

144

Phase 3

United States;Austria;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden

EUCTR2019-002817-21-BE
(EUCTR)

02/12/2019

A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.

Actelion Pharmaceuticals Ltd.

NULL

Female: yes
Male: yes

237

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

EUCTR2018-000145-39-PL
(EUCTR)

02/04/2019

A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension

A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Canada;Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;Italy;United Kingdom;Vietnam;France;Hungary;Malaysia;Poland;Singapore;Romania;Netherlands;Germany;China

EUCTR2019-002817-21-PL
(EUCTR)

15/10/2019

A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.

Actelion Pharmaceuticals Ltd.

NULL

Female: yes
Male: yes

237

Phase 3

United States;Belarus;Portugal;Serbia;Taiwan;Thailand;Spain;Ukraine;Israel;Russian Federation;Colombia;Switzerland;Italy;Vietnam;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden

EUCTR2019-002817-21-SE
(EUCTR)

29/10/2019

A study to see if it is safe and helpful to add Selexipag to other PAH medication in children and adolescents.

Actelion Pharmaceuticals Ltd.

NULL

Female: yes
Male: yes

237

Phase 3

EUCTR2018-000145-39-FR
(EUCTR)

26/04/2018

A clinical study to confirm the doses of selexipag to be used in children with pulmonary arterial hypertension

A prospective, multicenter, open-label, single-arm, Phase 2 study to investigate the safety, tolerability and pharmacokinetics of selexipag in children with pulmonary arterial hypertension

Actelion Pharmaceuticals Ltd

NULL

Female: yes
Male: yes

Phase 2

Serbia;United States;Belarus;Taiwan;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Vietnam;France;Hungary;Canada;Poland;Malaysia;Singapore;Romania;Netherlands;Germany;China