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	NCT03431649 (ClinicalTrials.gov)	April 1, 2017	29/7/2017	Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children	Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart Defect	Pediatric Pulmonary Hypertension	Drug: Beraprost Sodium;Drug: Sildenafil Citrate	Dr. Soetomo General Hospital	NULL	Completed	1 Year	17 Years	All	40	Phase 4	Indonesia
2	JPRN-UMIN000025176	2017/01/01	15/12/2016	Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension.		Pulmonary arterial hypertension	Medicine transition from beraprost to selexipag In accordance with the Japanese package insert (http://www.info.pmda.go.jp/go/pack/2190037F1020_1_02/), selexipag is initiated at a dose of 0.2mg twice daily and is increased in twice-daily increments of 0.2mg until unmanageable adverse effects associated with prostacyclin use, such as headache or jaw pain, developed. The maximum dose allowed is 1.6mg twice daily.	Hamamatsu University School of Medicine	NULL	Open public recruiting	16years-old	Not applicable	Male and Female	33	Not selected	Japan
3	NCT01966302 (ClinicalTrials.gov)	November 2013	15/10/2013	Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH)	Compassionate Use of Beraprost Sodium 314d Modified Release (BPS-314d-MR) for Three Patients With Pulmonary Arterial Hypertension (PAH).	Pulmonary Arterial Hypertension	Drug: BPS-314d-MR	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Lung Biotechnology PBC	Completed	18 Years	75 Years	All	1	Phase 2	United States
4	NCT01908699 (ClinicalTrials.gov)	May 31, 2013	16/7/2013	Beraprost-314d Added-on to Tyvaso® (BEAT)	A Multicenter, Double-blind, Randomized, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of Oral BPS-314d-MR added-on to Treprostinil, Inhaled (Tyvaso®) in Subjects With Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: Beraprost Sodium 314d Modified Release Tablets;Drug: Placebo	Lung Biotechnology PBC	NULL	Completed	18 Years	80 Years	All	273	Phase 3	United States;Israel
5	NCT01458236 (ClinicalTrials.gov)	November 2011	29/9/2011	A Multinational, Multicenter, Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor	A Multinational, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor	Pulmonary Arterial Hypertension	Drug: Beraprost Sodium 314d Modified Release Tablets;Drug: Placebo	Lung Biotechnology Inc.	NULL	Withdrawn	18 Years	80 Years	Both	0	Phase 3	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2009-014453-32-CZ (EUCTR)	15/07/2010	11/02/2010	NA	An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients	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] - Respiratory Tract Diseases [C08]	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung LLC	NULL	Not Recruiting			Female: yes Male: yes	36		Czech Republic;Belgium;Ireland;Germany
7	EUCTR2009-014246-29-DE (EUCTR)	08/04/2010	16/11/2009	A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)	A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)	Pulmonary Arterial Hypertension MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium	Lung Rx	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	36		Czech Republic;Germany;Belgium;Ireland
8	EUCTR2009-014246-29-CZ (EUCTR)	18/02/2010	07/12/2009	A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)	A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)	Pulmonary Arterial Hypertension MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung Rx Inc	NULL	Not Recruiting			Female: yes Male: yes	36		Germany;Czech Republic;Belgium;Ireland
9	NCT00989963 (ClinicalTrials.gov)	February 1, 2010	5/10/2009	Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH)	A 12-week, Double-blind, International, Multicenter, Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH)	Pulmonary Arterial Hypertension	Drug: Beraprost Sodium Modified Release	Lung Biotechnology PBC	NULL	Completed	18 Years	75 Years	All	36	Phase 2	United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic
10	EUCTR2009-014453-32-IE (EUCTR)	01/02/2010	09/11/2009	An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients	An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients	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	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung LLC Inc	NULL	Not Recruiting			Female: yes Male: yes	36		Czech Republic;Belgium;Ireland;Germany
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	EUCTR2009-014246-29-IE (EUCTR)	01/02/2010	06/11/2009	A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)	A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)	Pulmonary Arterial Hypertension MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium	Lung Rx	NULL	Not Recruiting			Female: yes Male: yes	36		Czech Republic;Germany;Belgium;Ireland
12	EUCTR2009-014453-32-BE (EUCTR)	11/01/2010	09/11/2009	An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients	An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients	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: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung LLC	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	United States;Czech Republic;Belgium;Ireland;Romania;Germany
13	EUCTR2009-014246-29-BE (EUCTR)	09/12/2009	09/11/2009	A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)	A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)	Pulmonary Arterial Hypertension MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung Rx Inc	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	Czech Republic;Belgium;Ireland;Germany
14	NCT00990314 (ClinicalTrials.gov)	November 30, 2009	5/10/2009	Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients	An Open-label Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients	Pulmonary Arterial Hypertension	Drug: Beraprost Sodium Modified Release	Lung Biotechnology PBC	NULL	Completed	18 Years	75 Years	All	31	Phase 2	United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic
15	EUCTR2008-006833-29-IE (EUCTR)	29/06/2009	11/12/2008	An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients	An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients	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: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung LLC	NULL	Not Recruiting			Female: yes Male: yes	19		Belgium;Ireland
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	EUCTR2008-003290-41-IE (EUCTR)	29/06/2009	11/12/2008	A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients	A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	LungRx	NULL	Not Recruiting			Female: yes Male: yes	10		Belgium;Ireland
17	ChiCTR-TCC-12002776	2009-05-01	2012-10-23	BEraproST combined therapy with Sildenafil for pulmonary arterial hypertension	BEraproST combined therapy with Sildenafil for pulmonary arterial hypertension	Pulmonary arterial hypertension	Group B :beraprost combined with sildenafil ;A:Sildenafil citrate ;	Shanghai Pulmonary Hospital	NULL	Completed	18	65	Both	Group B :30;A:30;		China
18	NCT00792571 (ClinicalTrials.gov)	February 28, 2009	14/11/2008	An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients	An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients.	Pulmonary Arterial Hypertension	Drug: Beraprost Sodium Modified Release	Lung Biotechnology PBC	NULL	Completed	18 Years	75 Years	All	18	Phase 2	United States;Belgium;Ireland
19	EUCTR2008-003290-41-BE (EUCTR)	04/02/2009	09/12/2008	A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients	A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients	Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung Rx	NULL	Not Recruiting			Female: yes Male: yes	20		Belgium;Ireland
20	EUCTR2008-006833-29-BE (EUCTR)	04/02/2009	16/12/2008	An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients	An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients	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: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung LLC	NULL	Not Recruiting			Female: yes Male: yes	19	Phase 2	United States;Belgium;Ireland
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	NCT00781885 (ClinicalTrials.gov)	January 31, 2009	27/10/2008	A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients	A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients	Pulmonary Arterial Hypertension	Drug: Beraprost sodium modified release	Lung Biotechnology PBC	NULL	Completed	18 Years	75 Years	All	19	Phase 2	United States;Belgium;Ireland
22	JPRN-UMIN000001350	2008/09/01	01/10/2008	Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases		Pulmonary arterial hypertension (PAH) associated with connective tissue disease	Beraprost sodium Beraprost sodium and Sildenafil citrate	Keio University	NULL	Complete: follow-up complete	18years-old	80years-old	Male and Female	70	Not selected	Japan
23	EUCTR2009-014453-32-DE (EUCTR)		11/12/2009	An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients	An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients	Pulmonary Arterial Hypertension MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR INN or Proposed INN: Beraprost Sodium Other descriptive name: TRK-100STP	Lung RX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	36		Czech Republic;Germany;Belgium;Ireland

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

NCT03431649
(ClinicalTrials.gov)

April 1, 2017

29/7/2017

Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart Defect

Pediatric Pulmonary Hypertension

Drug: Beraprost Sodium;Drug: Sildenafil Citrate

Dr. Soetomo General Hospital

NULL

Completed

1 Year

17 Years

All

Phase 4

Indonesia

JPRN-UMIN000025176

2017/01/01

15/12/2016

Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension.

Pulmonary arterial hypertension

Medicine transition from beraprost to selexipag

In accordance with the Japanese package insert (http://www.info.pmda.go.jp/go/pack/2190037F1020_1_02/), selexipag is initiated at a dose of 0.2mg twice daily and is increased in twice-daily increments of 0.2mg until unmanageable adverse effects associated with prostacyclin use, such as headache or jaw pain, developed.
The maximum dose allowed is 1.6mg twice daily.

Hamamatsu University School of Medicine

NULL

Open public recruiting

16years-old

Not applicable

Male and Female

Not selected

Japan

NCT01966302
(ClinicalTrials.gov)

November 2013

15/10/2013

Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH)

Compassionate Use of Beraprost Sodium 314d Modified Release (BPS-314d-MR) for Three Patients With Pulmonary Arterial Hypertension (PAH).

Pulmonary Arterial Hypertension

Drug: BPS-314d-MR

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Lung Biotechnology PBC

Completed

18 Years

75 Years

All

Phase 2

United States

NCT01908699
(ClinicalTrials.gov)

May 31, 2013

16/7/2013

Beraprost-314d Added-on to Tyvaso® (BEAT)

A Multicenter, Double-blind, Randomized, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of Oral BPS-314d-MR added-on to Treprostinil, Inhaled (Tyvaso®) in Subjects With Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension

Drug: Beraprost Sodium 314d Modified Release Tablets;Drug: Placebo

Lung Biotechnology PBC

NULL

Completed

18 Years

80 Years

All

273

Phase 3

United States;Israel

NCT01458236
(ClinicalTrials.gov)

November 2011

29/9/2011

A Multinational, Multicenter, Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor

A Multinational, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor

Pulmonary Arterial Hypertension

Drug: Beraprost Sodium 314d Modified Release Tablets;Drug: Placebo

Lung Biotechnology Inc.

NULL

Withdrawn

18 Years

80 Years

Both

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2009-014453-32-CZ
(EUCTR)

15/07/2010

11/02/2010

An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients

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] - Respiratory Tract Diseases [C08]

Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP

Lung LLC

NULL

Not Recruiting

Female: yes
Male: yes

Czech Republic;Belgium;Ireland;Germany

EUCTR2009-014246-29-DE
(EUCTR)

08/04/2010

16/11/2009

A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH)

Pulmonary Arterial Hypertension
MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium

Lung Rx

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Czech Republic;Germany;Belgium;Ireland

EUCTR2009-014246-29-CZ
(EUCTR)

18/02/2010

07/12/2009

Pulmonary Arterial Hypertension
MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP

Lung Rx Inc

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Czech Republic;Belgium;Ireland

NCT00989963
(ClinicalTrials.gov)

February 1, 2010

5/10/2009

Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH)

A 12-week, Double-blind, International, Multicenter, Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH)

Pulmonary Arterial Hypertension

Drug: Beraprost Sodium Modified Release

Lung Biotechnology PBC

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic

EUCTR2009-014453-32-IE
(EUCTR)

01/02/2010

09/11/2009

An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients

Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP

Lung LLC Inc

NULL

Not Recruiting

Female: yes
Male: yes

Czech Republic;Belgium;Ireland;Germany

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

EUCTR2009-014246-29-IE
(EUCTR)

01/02/2010

06/11/2009

Pulmonary Arterial Hypertension
MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium

Lung Rx

NULL

Not Recruiting

Female: yes
Male: yes

Czech Republic;Germany;Belgium;Ireland

EUCTR2009-014453-32-BE
(EUCTR)

11/01/2010

09/11/2009

An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients

Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP

Lung LLC

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Czech Republic;Belgium;Ireland;Romania;Germany

EUCTR2009-014246-29-BE
(EUCTR)

09/12/2009

09/11/2009

Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP

Lung Rx Inc

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Belgium;Ireland;Germany

NCT00990314
(ClinicalTrials.gov)

November 30, 2009

5/10/2009

Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients

An Open-label Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients

Pulmonary Arterial Hypertension

Drug: Beraprost Sodium Modified Release

Lung Biotechnology PBC

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic

EUCTR2008-006833-29-IE
(EUCTR)

29/06/2009

11/12/2008

An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients

Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP

Lung LLC

NULL

Not Recruiting

Female: yes
Male: yes

Belgium;Ireland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2008-003290-41-IE
(EUCTR)

29/06/2009

11/12/2008

A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients

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

Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP

LungRx

NULL

Not Recruiting

Female: yes
Male: yes

Belgium;Ireland

ChiCTR-TCC-12002776

2009-05-01

2012-10-23

BEraproST combined therapy with Sildenafil for pulmonary arterial hypertension

Pulmonary arterial hypertension

Group B :beraprost combined with sildenafil ;A:Sildenafil citrate ;

Shanghai Pulmonary Hospital

NULL

Completed

Both

Group B :30;A:30;

China

NCT00792571
(ClinicalTrials.gov)

February 28, 2009

14/11/2008

An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients

An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients.

Pulmonary Arterial Hypertension

Drug: Beraprost Sodium Modified Release

Lung Biotechnology PBC

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Belgium;Ireland

EUCTR2008-003290-41-BE
(EUCTR)

04/02/2009

09/12/2008

A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients

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

Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP

Lung Rx

NULL

Not Recruiting

Female: yes
Male: yes

Belgium;Ireland

EUCTR2008-006833-29-BE
(EUCTR)

04/02/2009

16/12/2008

An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients

Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP

Lung LLC

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Belgium;Ireland

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

NCT00781885
(ClinicalTrials.gov)

January 31, 2009

27/10/2008

A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients

Pulmonary Arterial Hypertension

Drug: Beraprost sodium modified release

Lung Biotechnology PBC

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Belgium;Ireland

JPRN-UMIN000001350

2008/09/01

01/10/2008

Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases

Pulmonary arterial hypertension (PAH) associated with connective tissue disease

Beraprost sodium
Beraprost sodium and Sildenafil citrate

Keio University

NULL

Complete: follow-up complete

18years-old

80years-old

Male and Female

Not selected

Japan

EUCTR2009-014453-32-DE
(EUCTR)

11/12/2009

An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients

Pulmonary Arterial Hypertension
MedDRA version: 12.0;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Product Name: Beraprost Sodium Modified Release
Product Code: BPS-MR
INN or Proposed INN: Beraprost Sodium
Other descriptive name: TRK-100STP

Lung RX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Czech Republic;Germany;Belgium;Ireland