DDrare: Database of Drug Development for Rare Diseases

86. 肺動脈性肺高血圧症
［臨床試験数：1,083，薬物数：667（DrugBank：122），標的遺伝子数：98，標的パスウェイ数：185］

Searched query = "Pulmonary arterial hypertension", "PAH", "IPAH", "HPAH", "Eisenmenger syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

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	EUCTR2019-003309-88-DE (EUCTR)	30/07/2020	21/02/2020	A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity	A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity	pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830	United Therapeutics Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	193	Phase 3	United States;Czech Republic;Argentina;Spain;Poland;Brazil;Belgium;Austria;Australia;Germany;United Kingdom;Italy
2	EUCTR2019-003309-88-AT (EUCTR)	14/07/2020	20/02/2020	A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy	A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity	pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830	United Therapeutics Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	193	Phase 3	United States;Czech Republic;Argentina;Spain;Poland;Brazil;Belgium;Australia;Austria;Germany;United Kingdom;Italy
3	EUCTR2018-001189-40-NL (EUCTR)	07/07/2020	19/12/2018	An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension	A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Portugal;Serbia;United States;Taiwan;Greece;Thailand;Ukraine;Israel;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Japan;Sweden
4	EUCTR2019-003309-88-GB (EUCTR)	02/06/2020	11/02/2020	A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy	A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity	pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830	United Therapeutics Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	193	Phase 3	United States;Czech Republic;Argentina;Spain;Poland;Brazil;Belgium;Austria;Australia;Germany;Italy;United Kingdom
5	EUCTR2019-003309-88-PL (EUCTR)	14/05/2020	26/02/2020	A Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity in Subjects with Pulmonary Hypertension	A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity	pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: RALINEPAG Other descriptive name: AR392830	United Therapeutics Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	193	Phase 3	United States;Czech Republic;Argentina;Brazil;Belgium;Spain;Poland;Austria;Australia;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
6	EUCTR2018-001189-40-PT (EUCTR)	02/09/2019	27/03/2019	An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension	A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830	United Therapeutic Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Serbia;Portugal;United States;Taiwan;Greece;Ukraine;Israel;Chile;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden
7	EUCTR2018-001187-33-PT (EUCTR)	02/09/2019	22/03/2019	A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.	A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes	pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA	United Therapeutics Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	700	Phase 3	European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden;Serbia;Portugal;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico
8	EUCTR2018-001189-40-BG (EUCTR)	10/04/2019	29/01/2019	An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension	A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830	United Therapeutics Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	United States;Serbia;Portugal;Taiwan;Greece;Ukraine;Israel;Chile;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden
9	EUCTR2018-001187-33-BG (EUCTR)	10/04/2019	13/12/2018	A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.	A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients - ADVANCE-outcomes	pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA	United Therapeutics Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	700	Phase 3	Portugal;United States;Serbia;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden
10	EUCTR2018-001189-40-GR (EUCTR)	03/04/2019	20/03/2019	An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension	A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag	United Therapeutics Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	United States;Serbia;Portugal;Taiwan;Greece;Ukraine;Israel;Chile;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;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	EUCTR2018-001187-33-GR (EUCTR)	03/04/2019	20/03/2019	A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.	A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients - ADVANCE-outcomes	pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Portugal;United States;Serbia;Taiwan;Greece;Thailand;Ukraine;Chile;Israel;Switzerland;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden
12	EUCTR2018-001189-40-IT (EUCTR)	21/02/2019	14/11/2019	An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension	A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag	United Therapeutics Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden
13	EUCTR2018-001187-33-BE (EUCTR)	18/02/2019	10/12/2018	A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.	A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes	pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830	United Therapeutics Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	700	Phase 3	Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Bulgaria;Germany;Sweden
14	EUCTR2018-001189-40-SE (EUCTR)	11/02/2019	19/11/2018	An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension	A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	1000	Phase 3	Serbia;United States;Portugal;Taiwan;Greece;Ukraine;Israel;Chile;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden
15	EUCTR2018-001187-33-SE (EUCTR)	05/02/2019	29/10/2018	A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.	A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes	pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830	United Therapeutics Corporation	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;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
16	EUCTR2018-001189-40-PL (EUCTR)	16/01/2019	21/03/2019	An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension	A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Portugal;Serbia;United States;Taiwan;Greece;Thailand;Ukraine;Israel;Chile;Italy;Switzerland;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Japan;Sweden
17	EUCTR2018-001187-33-PL (EUCTR)	16/01/2019	06/12/2018	A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.	A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes	pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830	United Therapeutics Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	700	Phase 3	Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden
18	EUCTR2018-001187-33-HU (EUCTR)	14/01/2019	06/11/2018	A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.	A Study Evaluating the EffiCacy and Safety of Ralinepag To Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes	pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: NA	United Therapeutics Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	700	Phase 3	Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden
19	EUCTR2018-001189-40-HU (EUCTR)	14/01/2019	21/01/2019	An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension	A study evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension	Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830 Product Name: Ralinepag Product Code: APD811 INN or Proposed INN: ralinepag Other descriptive name: AR392830	United Therapeutics Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 3	Portugal;United States;Serbia;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Bulgaria;Sweden
20	EUCTR2014-000667-40-SK (EUCTR)	17/01/2017	01/04/2016	A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.	A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension 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] - Respiratory Tract Diseases [C08]		Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	EUCTR2014-003042-27-SK (EUCTR)	26/05/2016	01/04/2016	Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)	An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension 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] - Respiratory Tract Diseases [C08]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria
22	EUCTR2014-000667-40-RO (EUCTR)	30/07/2015	02/10/2015	A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.	A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension	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] - Respiratory Tract Diseases [C08]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	Serbia;United States;Hungary;Czech Republic;Poland;Spain;Romania;Australia;Bulgaria
23	EUCTR2014-000667-40-PL (EUCTR)	30/07/2015	29/04/2015	A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.	A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension	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] - Respiratory Tract Diseases [C08]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Spain;Poland;Romania;Australia;Bulgaria
24	EUCTR2014-003042-27-RO (EUCTR)	30/07/2015	05/10/2015	Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)	An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension	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] - Respiratory Tract Diseases [C08]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60		Serbia;United States;Hungary;Czech Republic;Poland;Spain;Romania;Australia;Bulgaria
25	EUCTR2014-003042-27-PL (EUCTR)	23/07/2015	28/05/2015	Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)	An Open-Label Extension Study of APD811-003 in Patients 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]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Spain;Poland;Romania;Australia;Bulgaria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	EUCTR2014-003042-27-ES (EUCTR)	29/05/2015	09/03/2015	Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)	An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 17.1;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]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60		Serbia;United States;Hungary;Czech Republic;Poland;Spain;Romania;Australia;Bulgaria
27	EUCTR2014-000667-40-ES (EUCTR)	27/05/2015	09/03/2015	A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.	A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension	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] - Respiratory Tract Diseases [C08]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria
28	EUCTR2014-000667-40-CZ (EUCTR)	23/04/2015	14/01/2015	A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.	A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension 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] - Respiratory Tract Diseases [C08]		Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria
29	EUCTR2014-003042-27-CZ (EUCTR)	23/04/2015	14/01/2015	Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)	An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension 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] - Respiratory Tract Diseases [C08]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Poland;Romania;Australia;Bulgaria
30	EUCTR2014-000667-40-HU (EUCTR)	17/02/2015	19/01/2015	A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.	A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension	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] - Respiratory Tract Diseases [C08]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Serbia;United States;Czech Republic;Hungary;Slovakia;Poland;Spain;Romania;Australia;Bulgaria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	EUCTR2014-003042-27-HU (EUCTR)	17/02/2015	19/01/2015	Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)	An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension	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] - Respiratory Tract Diseases [C08]	Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830 Product Code: APD811 INN or Proposed INN: Ralinepag Other descriptive name: AR392830	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	United States;Serbia;Czech Republic;Hungary;Slovakia;Spain;Poland;Romania;Australia;Bulgaria
32	NCT02279160 (ClinicalTrials.gov)	December 2014	25/10/2014	Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension	A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of Ralinepag, an Oral IP Receptor Agonist, in Patients With Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: APD811;Drug: Placebo	United Therapeutics	NULL	Completed	18 Years	75 Years	All	61	Phase 2	United States;Australia;Bulgaria;Czechia;Hungary;Poland;Romania;Serbia;Spain;Czech Republic

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

EUCTR2019-003309-88-DE
(EUCTR)

30/07/2020

21/02/2020

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by Cardiopulmonary Exercise Testing in Subjects with World Health Organization Group 1 Pulmonary Hypertension Who Recently Initiated Therapy - ADVANCE Capacity

pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: RALINEPAG
Other descriptive name: AR392830
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: RALINEPAG
Other descriptive name: AR392830
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: RALINEPAG
Other descriptive name: AR392830

United Therapeutics Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

193

Phase 3

United States;Czech Republic;Argentina;Spain;Poland;Brazil;Belgium;Austria;Australia;Germany;United Kingdom;Italy

EUCTR2019-003309-88-AT
(EUCTR)

14/07/2020

20/02/2020

United Therapeutics Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

193

Phase 3

United States;Czech Republic;Argentina;Spain;Poland;Brazil;Belgium;Australia;Austria;Germany;United Kingdom;Italy

EUCTR2018-001189-40-NL
(EUCTR)

07/07/2020

19/12/2018

An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension

A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension

Pulmonary arterial hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077731;Term: Pulmonary hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Portugal;Serbia;United States;Taiwan;Greece;Thailand;Ukraine;Israel;Chile;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Bulgaria;Japan;Sweden

EUCTR2019-003309-88-GB
(EUCTR)

02/06/2020

11/02/2020

United Therapeutics Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

193

Phase 3

United States;Czech Republic;Argentina;Spain;Poland;Brazil;Belgium;Austria;Australia;Germany;Italy;United Kingdom

EUCTR2019-003309-88-PL
(EUCTR)

14/05/2020

26/02/2020

A Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity in Subjects with Pulmonary Hypertension

United Therapeutics Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

193

Phase 3

United States;Czech Republic;Argentina;Brazil;Belgium;Spain;Poland;Austria;Australia;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

EUCTR2018-001189-40-PT
(EUCTR)

02/09/2019

27/03/2019

An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension

A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension

Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: AR392830

United Therapeutic Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Serbia;Portugal;United States;Taiwan;Greece;Ukraine;Israel;Chile;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden

EUCTR2018-001187-33-PT
(EUCTR)

02/09/2019

22/03/2019

A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes

Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA
Product Name: Ralinepag
Product Code: APD811
INN or Proposed INN: ralinepag
Other descriptive name: NA

United Therapeutics Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Phase 3

European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden;Serbia;Portugal;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico

EUCTR2018-001189-40-BG
(EUCTR)

10/04/2019

29/01/2019

An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension

A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension

United Therapeutics Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

United States;Serbia;Portugal;Taiwan;Greece;Ukraine;Israel;Chile;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden

EUCTR2018-001187-33-BG
(EUCTR)

10/04/2019

13/12/2018

A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.

A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients - ADVANCE-outcomes

United Therapeutics Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Phase 3

Portugal;United States;Serbia;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden

EUCTR2018-001189-40-GR
(EUCTR)

03/04/2019

20/03/2019

An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension

A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension

United Therapeutics Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

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

EUCTR2018-001187-33-GR
(EUCTR)

03/04/2019

20/03/2019

A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.

A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients - ADVANCE-outcomes

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

Portugal;United States;Serbia;Taiwan;Greece;Thailand;Ukraine;Chile;Israel;Switzerland;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden

EUCTR2018-001189-40-IT
(EUCTR)

21/02/2019

14/11/2019

An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension

A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension

United Therapeutics Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden

EUCTR2018-001187-33-BE
(EUCTR)

18/02/2019

10/12/2018

A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes

United Therapeutics Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Phase 3

Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Bulgaria;Germany;Sweden

EUCTR2018-001189-40-SE
(EUCTR)

11/02/2019

19/11/2018

An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension

A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension

United Therapeutics Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3

Serbia;United States;Portugal;Taiwan;Greece;Ukraine;Israel;Chile;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Sweden

EUCTR2018-001187-33-SE
(EUCTR)

05/02/2019

29/10/2018

A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes

United Therapeutics Corporation

NULL

Not Recruiting

Female: yes
Male: yes

700

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

EUCTR2018-001189-40-PL
(EUCTR)

16/01/2019

21/03/2019

An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension

A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Portugal;Serbia;United States;Taiwan;Greece;Thailand;Ukraine;Israel;Chile;Italy;Switzerland;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Japan;Sweden

EUCTR2018-001187-33-PL
(EUCTR)

16/01/2019

06/12/2018

A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes

United Therapeutics Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Phase 3

Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden

EUCTR2018-001187-33-HU
(EUCTR)

14/01/2019

06/11/2018

A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension.

A Study Evaluating the EffiCacy and Safety of Ralinepag To Improve Treatment Outcomes in PAH Patients - ADVANCE-Outcomes

United Therapeutics Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Phase 3

Portugal;Serbia;United States;Taiwan;Greece;Ukraine;Israel;Chile;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Bulgaria;Germany;Sweden

EUCTR2018-001189-40-HU
(EUCTR)

14/01/2019

21/01/2019

An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension

A study evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension

United Therapeutics Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 3

Portugal;United States;Serbia;Taiwan;Greece;Ukraine;Israel;Chile;Italy;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Bulgaria;Sweden

EUCTR2014-000667-40-SK
(EUCTR)

17/01/2017

01/04/2016

A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.

A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension
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] - Respiratory Tract Diseases [C08]

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2014-003042-27-SK
(EUCTR)

26/05/2016

01/04/2016

Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)

An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension
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] - Respiratory Tract Diseases [C08]

Product Code: APD811
INN or Proposed INN: Ralinepag
Other descriptive name: AR392830
Product Code: APD811
INN or Proposed INN: Ralinepag
Other descriptive name: AR392830
Product Code: APD811
INN or Proposed INN: Ralinepag
Other descriptive name: AR392830
Product Code: APD811
INN or Proposed INN: Ralinepag
Other descriptive name: AR392830
Product Code: APD811
INN or Proposed INN: Ralinepag
Other descriptive name: AR392830

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria

EUCTR2014-000667-40-RO
(EUCTR)

30/07/2015

02/10/2015

A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.

A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension

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] - Respiratory Tract Diseases [C08]

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Poland;Spain;Romania;Australia;Bulgaria

EUCTR2014-000667-40-PL
(EUCTR)

30/07/2015

29/04/2015

A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.

A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension

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] - Respiratory Tract Diseases [C08]

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovakia;Spain;Poland;Romania;Australia;Bulgaria

EUCTR2014-003042-27-RO
(EUCTR)

30/07/2015

05/10/2015

Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)

An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Serbia;United States;Hungary;Czech Republic;Poland;Spain;Romania;Australia;Bulgaria

EUCTR2014-003042-27-PL
(EUCTR)

23/07/2015

28/05/2015

Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)

An Open-Label Extension Study of APD811-003 in Patients 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]

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovakia;Spain;Poland;Romania;Australia;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2014-003042-27-ES
(EUCTR)

29/05/2015

09/03/2015

Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)

An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension
MedDRA version: 17.1;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]

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Serbia;United States;Hungary;Czech Republic;Poland;Spain;Romania;Australia;Bulgaria

EUCTR2014-000667-40-ES
(EUCTR)

27/05/2015

09/03/2015

A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.

A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria

EUCTR2014-000667-40-CZ
(EUCTR)

23/04/2015

14/01/2015

A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.

A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria

EUCTR2014-003042-27-CZ
(EUCTR)

23/04/2015

14/01/2015

Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)

An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension
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] - Respiratory Tract Diseases [C08]

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Poland;Romania;Australia;Bulgaria

EUCTR2014-000667-40-HU
(EUCTR)

17/02/2015

19/01/2015

A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension.

A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Czech Republic;Hungary;Slovakia;Poland;Spain;Romania;Australia;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2014-003042-27-HU
(EUCTR)

17/02/2015

19/01/2015

Follow-up study to further investigate long-term safety and tolerability of the study drug APB811 in patients with Pulmonary Arterial Hypertension that have completed the initial study (003)

An Open-Label Extension Study of APD811-003 in Patients with Pulmonary Arterial Hypertension

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Serbia;Czech Republic;Hungary;Slovakia;Spain;Poland;Romania;Australia;Bulgaria

NCT02279160
(ClinicalTrials.gov)

December 2014

25/10/2014

Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension

A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of Ralinepag, an Oral IP Receptor Agonist, in Patients With Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension

Drug: APD811;Drug: Placebo

United Therapeutics

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Australia;Bulgaria;Czechia;Hungary;Poland;Romania;Serbia;Spain;Czech Republic