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	EUCTR2012-002354-23-NL (EUCTR)	18/10/2013	31/05/2013	A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.	A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric 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]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: Tadalafil oral suspension Product Code: LY450190 INN or Proposed INN: TADALAFIL	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	134		United States;Spain;Austria;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan
2	EUCTR2012-002354-23-BE (EUCTR)	19/08/2013	25/02/2013	A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.	A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric 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]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: Tadalafil oral suspension Product Code: LY450190 INN or Proposed INN: TADALAFIL	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	35	Phase 3	United States;Spain;Austria;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan
3	EUCTR2012-002354-23-RO (EUCTR)	17/07/2013	23/07/2014	A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.	A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: Tadalafil oral suspension Product Code: LY450190 INN or Proposed INN: TADALAFIL	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	134		United States;Spain;Austria;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan
4	EUCTR2012-002354-23-AT (EUCTR)	23/05/2013	01/03/2013	A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.	A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric 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]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: Tadalafil oral suspension Product Code: LY450190 INN or Proposed INN: TADALAFIL	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	35	Phase 3	United States;Spain;Austria;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan
5	EUCTR2012-002354-23-IT (EUCTR)	12/04/2013	27/02/2013	A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.	A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension	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]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: Tadalafil oral suspension Product Code: LY450190 INN or Proposed INN: TADALAFIL	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	134	Phase 3	United States;Spain;Austria;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan
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	EUCTR2011-001873-24-GB (EUCTR)	29/03/2012	24/11/2011	A study in children with Pulmonary Arterial Hypertension to assess the safety of Tadalafil as the dose increases, as well as how the drug works in the body	A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population 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]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: LY450190 Product Code: LY450190 INN or Proposed INN: TADALAFIL Other descriptive name: LY450190	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 1;Phase 2	United States;France;Canada;Spain;Poland;United Kingdom
7	EUCTR2011-001873-24-ES (EUCTR)	13/01/2012	26/10/2011	A study in children with Pulmonary Arterial Hypertension to assess the safety of Tadalafil as the dose increases, as well as how the drug works in the body	A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: LY450190 Product Code: LY450190 INN or Proposed INN: TADALAFIL Other descriptive name: LY450190	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	24		United Kingdom;Canada;France;Spain;United States;Poland
8	EUCTR2009-011150-17-BE (EUCTR)	15/11/2010	14/06/2010	Study of two drugs used to treat pulmonary arterial hypertension (PAH)	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Pulmonary arterial hypotension MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	614		United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
9	EUCTR2009-011150-17-NL (EUCTR)	26/08/2010	26/05/2010	Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Pulmonary arterial hypotension 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] - Virus Diseases [C02]	Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	GlaxoSmithKline R&D Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	545		Germany;United Kingdom;Netherlands;France;Spain;Italy;Japan;Greece;Austria;Sweden
10	EUCTR2009-011150-17-DE (EUCTR)	16/08/2010	03/08/2010	Study of two drugs used to treat pulmonary arterial hypertension (PAH)	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Pulmonary arterial hypotension 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]	Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	614		United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;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	EUCTR2009-011150-17-IT (EUCTR)	06/08/2010	09/08/2010	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911	Trade Name: VOLIBRIS Trade Name: CIALIS INN or Proposed INN: Tadalafil	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	352		France;Greece;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
12	EUCTR2009-011150-17-AT (EUCTR)	03/08/2010	22/06/2010	Study of two drugs used to treat pulmonary arterial hypertension (PAH)	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Pulmonary arterial hypotension 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]	Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	545		United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
13	EUCTR2009-011150-17-GR (EUCTR)	16/07/2010	14/07/2010	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Pulmonary arterial hypotension MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders	Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	352		France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
14	EUCTR2009-011150-17-SE (EUCTR)	14/07/2010	18/06/2010	Study of two drugs used to treat pulmonary arterial hypertension (PAH)	AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Pulmonary arterial hypotension 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]	Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL	GlaxoSmithKline R&D Ltd	NULL	Not Recruiting			Female: yes Male: yes	545		United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
15	EUCTR2009-011150-17-ES (EUCTR)	13/07/2010	02/06/2010	AMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	AMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION	Hipertensión arterial pulmonar MedDRA version: 11;Level: PT;Classification code 10064911;Term: Hipertensión arterial pulmonar MedDRA version: 11;Level: LLT;Term: Hipertensión arterial pulmonar	Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película INN or Proposed INN: AMBRISENTAN Other descriptive name: AMBRISENTAN Trade Name: CIALIS 20 mg comprimidos recubiertos con película INN or Proposed INN: TADALAFILO Other descriptive name: TADALAFIL	GlaxoSmithKline,S.A.	NULL	Not Recruiting			Female: yes Male: yes	352		France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2005-002844-24-ES (EUCTR)	22/03/2006	12/12/2005	- Estudio doble ciego de extensión para evaluar la seguridad y eficacia a largo plazo del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	- Estudio doble ciego de extensión para evaluar la seguridad y eficacia a largo plazo del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	La hipertensión arterial pulmonar (HAP) es una enfermedad crónica y progresiva caracterizada por el aumento de la presión arterial pulmonar y de la resistencia vascular pulmonar, conduciendo a insuficiencia cardíaca derecha y muerte	Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil	Lilly ICOS LLC	NULL	Not Recruiting			Female: yes Male: yes	350		Germany;United Kingdom;Ireland;Spain;Italy
17	EUCTR2005-002844-24-IE (EUCTR)	23/02/2006	12/10/2005	A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.	Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil	Lilly ICOS LLC	NULL	Not Recruiting			Female: yes Male: yes	350		Germany;United Kingdom;Spain;Ireland;Italy
18	EUCTR2005-002692-33-DE (EUCTR)	17/02/2006	21/10/2005	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY	Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.	Product Name: Cialis INN or Proposed INN: Tadalafil Product Name: Cialis INN or Proposed INN: Tadalafil Product Name: Tadalafil INN or Proposed INN: Tadalafil	Lilly ICOS LLC	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Spain;Ireland;Germany;Italy;United Kingdom
19	EUCTR2005-002692-33-ES (EUCTR)	02/02/2006	12/12/2005	Estudio aleatorizado, doble ciego, comparativo con placebo y Fase III del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY	Estudio aleatorizado, doble ciego, comparativo con placebo y Fase III del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY	La hipertensión arterial pulmonar (HAP) es una enfermedad crónica y progresiva caracterizada por el aumento de la presión arterial pulmonar y de la resistencia vascular pulmonar, conduciendo a insuficiencia cardíaca derecha y muerte	Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil	Lilly ICOS LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 3	Germany;United Kingdom;Ireland;Spain;Italy
20	EUCTR2005-002692-33-BE (EUCTR)	25/01/2006	26/10/2005	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY	Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.	Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil	Lilly ICOS LLC	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	Spain;Belgium;Ireland;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
21	EUCTR2005-002844-24-BE (EUCTR)	25/01/2006	26/10/2005	An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension	Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil	Eli Lilly and Company Limited	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3;Phase 4	Spain;Belgium;Ireland;Germany;Italy;United Kingdom
22	EUCTR2005-002844-24-DE (EUCTR)	17/01/2006	11/10/2005	An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX	Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.	Trade Name: Cialis Product Name: Cialis INN or Proposed INN: Tadalafil	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	350		Spain;Ireland;Germany;Italy;United Kingdom
23	EUCTR2011-001873-24-PL (EUCTR)		09/12/2011	A study in children with Pulmonary Arterial Hypertension to assess the safety of Tadalafil as the dose increases, as well as how the drug works in the body	A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population 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]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: LY450190 Product Code: LY450190 INN or Proposed INN: TADALAFIL Other descriptive name: LY450190	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 1;Phase 2	France;United States;Canada;Spain;Poland;United Kingdom
24	EUCTR2012-002354-23-GB (EUCTR)		16/01/2013	A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.	A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension MedDRA version: 15.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: Cialis 2.5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 5 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 10 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Cialis 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Product Name: Tadalafil oral suspension Product Code: LY450190 INN or Proposed INN: TADALAFIL	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	134	Phase 3	United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan

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

EUCTR2012-002354-23-NL
(EUCTR)

18/10/2013

31/05/2013

A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.

A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric 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]

Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: Tadalafil oral suspension
Product Code: LY450190
INN or Proposed INN: TADALAFIL

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

134

United States;Spain;Austria;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan

EUCTR2012-002354-23-BE
(EUCTR)

19/08/2013

25/02/2013

A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.

A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric 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]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Spain;Austria;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan

EUCTR2012-002354-23-RO
(EUCTR)

17/07/2013

23/07/2014

A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.

A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension
MedDRA version: 17.0;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]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

134

United States;Spain;Austria;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan

EUCTR2012-002354-23-AT
(EUCTR)

23/05/2013

01/03/2013

A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.

A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United States;Spain;Austria;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan

EUCTR2012-002354-23-IT
(EUCTR)

12/04/2013

27/02/2013

A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.

A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension

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]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

134

Phase 3

United States;Spain;Austria;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan

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

EUCTR2011-001873-24-GB
(EUCTR)

29/03/2012

24/11/2011

A study in children with Pulmonary Arterial Hypertension to assess the safety of Tadalafil as the dose increases, as well as how the drug works in the body

A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population 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]

Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: LY450190
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Other descriptive name: LY450190

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2

United States;France;Canada;Spain;Poland;United Kingdom

EUCTR2011-001873-24-ES
(EUCTR)

13/01/2012

26/10/2011

A study in children with Pulmonary Arterial Hypertension to assess the safety of Tadalafil as the dose increases, as well as how the drug works in the body

A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension
MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: LY450190
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Other descriptive name: LY450190

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Canada;France;Spain;United States;Poland

EUCTR2009-011150-17-BE
(EUCTR)

15/11/2010

14/06/2010

Study of two drugs used to treat pulmonary arterial hypertension (PAH)

AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION

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

Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

614

United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden

EUCTR2009-011150-17-NL
(EUCTR)

26/08/2010

26/05/2010

Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension

AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION

Pulmonary arterial hypotension
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] - Virus Diseases [C02]

GlaxoSmithKline R&D Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

545

Germany;United Kingdom;Netherlands;France;Spain;Italy;Japan;Greece;Austria;Sweden

EUCTR2009-011150-17-DE
(EUCTR)

16/08/2010

03/08/2010

Study of two drugs used to treat pulmonary arterial hypertension (PAH)

AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

614

United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2009-011150-17-IT
(EUCTR)

06/08/2010

09/08/2010

AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION

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

Trade Name: VOLIBRIS
Trade Name: CIALIS
INN or Proposed INN: Tadalafil

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

352

France;Greece;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden

EUCTR2009-011150-17-AT
(EUCTR)

03/08/2010

22/06/2010

Study of two drugs used to treat pulmonary arterial hypertension (PAH)

AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

545

United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden

EUCTR2009-011150-17-GR
(EUCTR)

16/07/2010

14/07/2010

AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION

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

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

352

France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden

EUCTR2009-011150-17-SE
(EUCTR)

14/07/2010

18/06/2010

Study of two drugs used to treat pulmonary arterial hypertension (PAH)

AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

545

United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden

EUCTR2009-011150-17-ES
(EUCTR)

13/07/2010

02/06/2010

AMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION

Hipertensión arterial pulmonar
MedDRA version: 11;Level: PT;Classification code 10064911;Term: Hipertensión arterial pulmonar
MedDRA version: 11;Level: LLT;Term: Hipertensión arterial pulmonar

Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
Trade Name: CIALIS 20 mg comprimidos recubiertos con película
INN or Proposed INN: TADALAFILO
Other descriptive name: TADALAFIL

GlaxoSmithKline,S.A.

NULL

Not Recruiting

Female: yes
Male: yes

352

France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2005-002844-24-ES
(EUCTR)

22/03/2006

12/12/2005

- Estudio doble ciego de extensión para evaluar la seguridad y eficacia a largo plazo del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX

La hipertensión arterial pulmonar (HAP) es una enfermedad crónica y progresiva caracterizada por el aumento de la presión arterial pulmonar y de la resistencia vascular pulmonar, conduciendo a insuficiencia cardíaca derecha y muerte

Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil

Lilly ICOS LLC

NULL

Not Recruiting

Female: yes
Male: yes

350

Germany;United Kingdom;Ireland;Spain;Italy

EUCTR2005-002844-24-IE
(EUCTR)

23/02/2006

12/10/2005

A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX

Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.

Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil

Lilly ICOS LLC

NULL

Not Recruiting

Female: yes
Male: yes

350

Germany;United Kingdom;Spain;Ireland;Italy

EUCTR2005-002692-33-DE
(EUCTR)

17/02/2006

21/10/2005

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY

Product Name: Cialis
INN or Proposed INN: Tadalafil
Product Name: Cialis
INN or Proposed INN: Tadalafil
Product Name: Tadalafil
INN or Proposed INN: Tadalafil

Lilly ICOS LLC

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Spain;Ireland;Germany;Italy;United Kingdom

EUCTR2005-002692-33-ES
(EUCTR)

02/02/2006

12/12/2005

Estudio aleatorizado, doble ciego, comparativo con placebo y Fase III del inhibidor de la fosfodiesterasa tipo 5 (PDE5) tadalafilo en el tratamiento de pacientes con hipertensión arterial pulmonarA Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY

Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil
Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil

Lilly ICOS LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 3

Germany;United Kingdom;Ireland;Spain;Italy

EUCTR2005-002692-33-BE
(EUCTR)

25/01/2006

26/10/2005

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY

Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil

Lilly ICOS LLC

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Spain;Belgium;Ireland;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

EUCTR2005-002844-24-BE
(EUCTR)

25/01/2006

26/10/2005

An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX

Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterized by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension

Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil

Eli Lilly and Company Limited

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3;Phase 4

Spain;Belgium;Ireland;Germany;Italy;United Kingdom

EUCTR2005-002844-24-DE
(EUCTR)

17/01/2006

11/10/2005

An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX

Trade Name: Cialis
Product Name: Cialis
INN or Proposed INN: Tadalafil

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

350

Spain;Ireland;Germany;Italy;United Kingdom

EUCTR2011-001873-24-PL
(EUCTR)

09/12/2011

A study in children with Pulmonary Arterial Hypertension to assess the safety of Tadalafil as the dose increases, as well as how the drug works in the body

A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial Hypertension

Trade Name: Cialis 2.5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 5 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 10 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Cialis 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Product Name: LY450190
Product Code: LY450190
INN or Proposed INN: TADALAFIL
Other descriptive name: LY450190

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2

France;United States;Canada;Spain;Poland;United Kingdom

EUCTR2012-002354-23-GB
(EUCTR)

16/01/2013

A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children.

A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension
MedDRA version: 15.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

134

Phase 3

United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan