DDrare: Database of Drug Development for Rare Diseases

Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
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 = 0,5 mg Prevenar i.m.; 0,5 mg seasonal influenza vaccine i.m.; 0.9% sodium chloride; 1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID; 1-22460; 10% Nitroglycerine in Propylene Glycol, USP; 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt; ABR-215757; ACHIM as solute (10^9 intestinal microbes/ml); ACT-064992; ACT-293987; 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; ADSVF application in the right hand; AIMSPRO; AL; AM-01; ANTI-HUMAN T-LYMPHOCYTE IMMUNOGLOBULIN FROM RABBITS; ASASANTIN Retard; ASC; AUC of MPA measure; AVID200; Abatacept; Abituzumab; Abituzumab 1500 mg; Abituzumab 500 mg; Acetaminophen; Acetate; Acetylcysteine; Acetylsalicylic acid; Acotiamide; Adempas; Administration of rituximab and methylprednisolone; Air; Ajulemic acid; Albumin; Alemtuzumab; Alginic acid; Allogeneic Mesenchymal Stem Cells (AlloMSC); Alpha-2C AR antagonist; Alprostadil; Ambrisentan; Amlodipine; Amlodipine Gel; Anaerobically Cultivated Human Intestinal Microbiota; Anaerobically Cultivated medium; Anti-CT51 antigen mAb; Anti-Thymocyte Globulin; Anti-Thymocyte Globulin, Rabbit; Anti-integrin alphaV mAb; Anti-pandemic H1N1 influenza vaccine; Anti-thymocyte globulin; Asasantin Retard ®; Aspirin; Atorvastatin; Autologous ASC; Autologous Stem Cells; Autologous stemcell transplantation with CD (cluster of differentiation) 34 selected stem cells; Aviptadil; BAY63-2521; BERMEKIMAB; BH4; BIBF 1120; BMS-986020; BOSENTAN MONOHYDRATE; BOTOX® solution; Beam; Belimumab; Belumosudil (KD025); Bermekimab; Biopsy; Blood coagulation factor XIII; Blood sample; Blood samples; Blood sampling; Bortezomib; Bosentan; Bosentan (Tracleer); Bosentan 125 mg; Bosentan 62.5 mg; Bosentan group; Bosentan monohydrate; Botox; Botulinum Toxin Type B; Botulinum toxin A; Botulinum toxin type B (2500 units / vial); Botulinum toxin(Botox); Bovine type I collagen; Brentuximab; Brentuximab Vedotin; Brentuximab vedotin; Brodalumab; Bupivacaine; Buspirone; Busulfan; Butanoic acid; C-82 Topical Gel, 1%; C21; C225; CAM2043; CAPILLAREMA; CC; CC-4047; CD; CD34 selected autologous hematopoietic cells; CD34+SC; CILOSTAZOL; CYCLOPHOSPHAMIDE; Calcipotriene; Calcium; Calcium Channel Blockers; Campath; Carbon; Carbon dioxide; Cetuximab; Chloride; Cialis; Cilostazol; Clobetasol; Cuprimine (penicillamine); Currently available therapy in the community; Cutaneous iontophoresis of treprostinil; Cyclophosphamide; Cyclophosphamide Injection 1g; DI-17E6; DIGNA P144 CREAM; DIGNA P144 cream; Dabigatran; Dabigatran etexilate; Dasatinib; Depot leuprolide acetate 3.75 mg; Dersimelagon; Device: Air filled balloon catheter; Device: Fractional carbon dioxide laser; Device: Manual toothbrush; Device: Manual toothbrush and water flosser (Philips Sonicare AirFloss); Device: Measurment with Aspirational Medical Device; Device: Measurment with Cutometer MPA 580; Device: Serial night time position splint; Device: Solid state catheter; Device: Sonic toothbrush; Device: Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss); Device: Ultraviolet A1 phototherapy (UVA1); Device: the ozone generator device (Human Pro medic, German); Diagnostic Test: CMRI; Diagnostic Test: Imaging; Diagnostic Test: P-MPA concentration; Diagnostic Test: Pulmonary function test; Diltiazem; Diltiazem Gel 2%; Dimethyl Fumarate (DMF); Dimethyl fumarate; Diphenhydramine; Dipyridamole; Divalproex sodium; Domperidone; Double-Blind Rituximab; Drug treatment; Dupilumab; Dupilumab 300Mg Solution for Injection; EDTA; EMA/CHMP/212874/2015; EMD 525797; ENDOPROST; ENDOPROST - 0.05 MG/0.5 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FIALA; ENDOPROST 0,05MG/0,5ML 1F; ENDOPROST 50*INFUS 1F 0,050MG/; EX VIVO CULTURED HUMAN MESENCHYMAL STEM CELLS; Endoprost; Endothelin receptor blocker; Erbitux; Esbriet; Ethanol; FILGRASTIM; FT011; Factor XIII; Fasudil; Fibrogammin® 1250; Fibrogammin®P, coagulation factor XIII concentrate (Human); Filgrastim; Fludarabine; Fludarabine phosphate; Fresolimumab; From August 2020 'no additional treatment'; G-CSF; G451990; GLIVEC; GLPG1690; GM-CSF; GS-248; GSK2330811; GSK2330811 Solution for Injection, 100mg/ml; Genetic: FCX-013; Glivec; Glivec 100 mg Filmtabletten; Glycyrrhizin; Gran; HIDONAC*EV 1FL 5G 25ML; HUMAN NORMAL IMMUNOGLOBULIN; Hematopoietic stem cell transplantation; High-dose intravenous immunoglobulin (Venoglobulin-IH); Hizentra; Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody; Human normal immunoglobulin; Human normal immunoglobulin for intravenous (IV) administration; Human normal immunoglobulin for intravenous administration; Human normal immunoglobulin for subcutaneous administration; Hyaluronidase; Hyaluronidase injected intradermally; Hyperimmune caprine serum; Hyperoxia; ILOPROST SALE DI TROMETAMOLO; ILOPROST TROMETAMOL; IMATINIB MESILATO; INCB039110; INJECTION OF ALLOGENEIC MESENCHYMAL STEM CELLS; INTERLEUKIN 2; ITACITINIB; IV Cyclophosphamide; IVA337; IVIg; Ifetroban; IgPro10; IgPro20; Iguratimod; Ilomedin; Iloprost; Iloprost Injection, for intravenous use; Iloprost low dose; Iloprost therapy up to 2 ng/kg x min; Iloprost trometamol; Imatinib; Imatinib Mesylate; Imatinib mesylate; Imiquimod; Imiquimod 5% cream; Imnovid; Imnovid 1 mg hard capsules; Indocyanine Green; Indocyanine green; Indole; Influenza vaccine; Injection of autologous stromal vascular fraction; Interleukin 2; Intravenous immunoglobulin; Iontophoresis of treprostinil; Itacitinib; JBT-101; KHK4827; LANIFIBRANOR; LENABASUM; Lactobacillus; Lanifibranor; Lenabasum; Lenabasum 20 mg; Lenabasum 20 mg Powder in Capsule; Lenabasum 5 mg; Lenabasum 5 mg Powder in Capsule; Leuprolide; Lidocaine; Lidocaine 2% without vessel constrictor; Lipitor; Liposomal bupivacaine; MABp1 (Bermekimab); MEDI-546; MEDI-551; MESNA; METHYLPREDNISOLONE; METHYLPREDNISOLONE SODIUM SUCCINATE; METOCLOPRAMIDE; METOCLOPRAMIDE ACCORD - 10 MG COMPRESSE 28 COMPRESSE IN BLISTER PVC/PVDC/AL; MHSCT; MMF; MPA; MQX-503; MSC; MT-7117; MabThera; Mabthera; Macitentan; Macitentan 10 mg; Macitentan 10mg; Macitentan 3 mg; Macitentan 3mg; Medrone; Mesenchymal Stem Cells from Wharton ´s jellyintravenous infusion of Mesenchymal Stem Cells from Wharton ´s jelly; Mesenchymal Stromal Cells; Mesenchymal stem cells; Mesenchymal stromal cells; Mesna; Methotrexate; Methylprednisolon; Methylprednisolone; Methylprednisolone acetate; Metoclopramide; Metronidazole; Mg; Microgynon; Mizoribine; Mycophenolate; Mycophenolate Mofetil; Mycophenolate Mofetil (MMF); Mycophenolate mofetil; Mycophenolic Acid; Mycophenolic acid; N-acetylcysteine (NAC); NAC; ND; NINTEDANIB; NON PROPIETRY, THEREFORE N/A; Neovasculgen; Neupogen; Nilotinib; Nilotinib (Tasigna); Nintedanib; Nitroglycerin; Nitroglycerin Ointment 2%; Nitroglycerine; Nitroglycerine gel; Nitroprusside; Nivolumab; Non applicabile; Null; ORENCIA; ORM-12471; ORM-12471 30mg; ORM-12741; Ofev; Omeprazole; Omeprazole 20mg; Onabotulinumtoxin A; Ophthalmic Emulsion; Opsumit 10 Mg Tablet; Oral Ifetroban; Oral bovine type I collagen; Oral treprostinil; Orencia; Other vasodilator; Other: Biopsy; Other: Bronchoalveolar samples; Other: Laboratory Biomarker Analysis; Other: Physalis angulata ethanol extract; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Rosemary essential oil; Other: Vasculopathy assessment; Other: flow cytometry; Other: laboratory biomarker analysis; Other: sodium chloride; Ozone; P144; P144 Cytokine Inhibitor; P144 Cytokines Inhibitors; P144 DIGNA CREAM; P144 cream; P144. Cytokines Inhibitors; PFD; PIRFENIDONE; PLETAL; PR1; PRUCALOPRIDE SUCCINATE; Paquinimod; Part B Open-Label Extension; Patients will be randomized to receive EHP-101; Penicillamine; Peripheral Blood Stem Cells; Phosphate; Phosphodiesterase Inhibitors; Physiological saline; Pirfenidone; Pirfenidone (PFD); Placebo; Platelet Gel; Plerixafor; Pletal; Polydeoxyribonucleotides; Pomalidomida; Pomalidomide; Pomalidomide (CC-4047); Prednisolon; Prednisolona; Prednisolone; Prednisolone 5 mg; Prednisolone 5mg Gastro-resistant Tablets; Prednisolone and taper; Prednisoloni; Prednisolonum; Prednisone; Prednizolon; Prednizolonas; Privigen; Procedure: 2 ml of whole blood sample will be collected on EDTA tube; Procedure: Adipose tissue harvest; Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Leukapheresis; Procedure: Leukopheresis; Procedure: Order of two elements of surgical procedure; Procedure: Peripheral Blood Stem Cell Transplantation; Procedure: Reduced Intensity Allogeneic Transplant; Procedure: Self bone marrow transplant; Procedure: Total Body Irradiation; Procedure: Total-Body Irradiation; Procedure: biopsy; Procedure: bone marrow transplantation; Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation; Procedure: peripheral blood stem cell transplantation; Procedure: quality-of-life assessment; Procedure: reduced intensity allogeneic hematopoietic stem cell transplantation; Procedure: stem cell transplantation; Propylene glycol; Prostanoids; Prucalopride; QAX576; RATG; RESOLOR*28CPR RIV 2MG; RIOCIGUAT; RO487-7533/F10-04; Rabbit; Rabeprazole; Radiation: Cone Beam Computed Tomography (CBCT); Radiation: Intensity-Modulated Radiation Therapy; Radiation: Total Body Irradiation; Radiation: total-body irradiation; Rapamycin; RbATG; Recombinant humanized anti-human monoclonal antibody directed against the IL-6R; Relaxin; Resolor; Resunab, ajulemic acid, anabasum; Rilonacept; Ringer lactate; Riocigu; Riociguat; Riociguat (Adempas, BAY63-2521); Riociguat coated tablet 0.5 mg; Riociguat coated tablet 1.0 mg; Riociguat coated tablet 1.5 mg; Riociguat coated tablet 2.0 mg; Riociguat coated tablet 2.5 m; Riociguat coated tablet 2.5 mg; Rituximab; Ro 47-0203; Ro 487-7533/F10-04; Ro47-0203 / ACT-050088; RoActemra; RoActemra 162 mg; Rosemary; Rosuvastatin; SAR100842; SAR156597; SAR156597 (ACT14604); SAR231893; SELEXIPAG; SINVACOR*28CPR RIV 20MG; SODIUM NITROPRUSSIDE; SODIUM THIOSULFATE PENTAHYDRATE; STI571; STS; Saccharomyces; Saccharomyces Boulardii Oral Tablet; Selexipag; Sildenafil; Sildenafil 20mg; Sildenafil 20mg and Bosentan 62.5mg; Sildenafil citrate; Sildenafil therapy; Simvastatin; Sinvacor; Sirolimus; Sodium Thiosulfate 10%; Sodium chloride; Sodium fluoride; Sodium fluoride 18F; Sodium thiosulfate; Sodium thiosulfate 10%; Solu-Medrol; Solu-Medrone; Solu-medrol; Solu-medrone; Soluble Ve cadherin; Standard of care; Sterile saline solution; Steroids; Stromal Vascular fraction; Study of the gene expression profile; TEPEZZA; TERGURIDE HYDROGENMALEATE; TOCILIZUMAB; TRACLEER*125MG 56CPR RIV.; TRACLEER*56CPR RIV 125MG; TREPROSTINIL SODIUM; Tacrolimus; Tadalafil; Tadalafil and ambrisentan upfront combination therapy; Tepezza; Terguride; Thalidomide; Thiotepa; Thymoglobulin; Thymoglobuline; Tocilizumab; Tocilizumab SC 162 mg/0.9 ml prefilled syringe with safety device (PFS); Tocilizumab [RoActemra/Actemra]; Tofacitinib; Topical AmphiMatrix; Topical AmphiMatrix with nitroglycerin (MQX-503); Topical calcipotriene 0.005% ointment; Topical organogel with nitroglycerin; Tracleer; Transdihydrolisuride; Treprostinil; Treprostinil Sodium; Treprostinil diethanolamine; Trimebutine; Trometamol; UCMSC; UT-15 SR; UT-15C SR; UT-15C-SR; Urine sample; VIB7734; VIP; Vaseline; Veledimex; Vessel; Vivomixx probiotics; Volibris; Water; Yellow Fever Vaccine; Yellow Fever vaccine (17D); ZD4054; Zibotentan; Ziritaxestat

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2010-022710-77-CZ (EUCTR)	06/01/2014	02/02/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	295		Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
2	EUCTR2010-022710-77-PL (EUCTR)	30/05/2012	12/03/2012	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
3	EUCTR2010-022969-95-PL (EUCTR)	30/05/2012	12/03/2012	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand
4	EUCTR2010-022710-77-IT (EUCTR)	11/04/2012	09/02/2012	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis. - DUAL-1 (Digital Ulcers with mAcitentan in systemic scLerosis)	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: NA Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: NA	ACTELION PHARMACEUTICALS LTD.	NULL	Not Recruiting			Female: yes Male: yes	285		United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;Hungary;European Union;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
5	EUCTR2010-022969-95-GR (EUCTR)	02/04/2012	28/03/2012	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2010-022969-95-NL (EUCTR)	27/02/2012	12/12/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand
7	EUCTR2010-022969-95-PT (EUCTR)	03/02/2012	12/12/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		United States;Portugal;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand
8	EUCTR2010-022969-95-BE (EUCTR)	16/01/2012	29/11/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285	Phase 3	Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand
9	EUCTR2010-022710-77-FI (EUCTR)	10/01/2012	07/12/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
10	EUCTR2010-022969-95-GB (EUCTR)	21/12/2011	27/01/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	295	Phase 3	Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2010-022969-95-IE (EUCTR)	07/12/2011	31/01/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	295		Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand
12	NCT01474122 (ClinicalTrials.gov)	December 2011	31/10/2011	Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients	Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic Sclerosis	Digital Ulcers	Drug: Macitentan 3 mg;Drug: Macitentan 10 mg;Drug: Placebo	Actelion	NULL	Terminated	18 Years	N/A	All	265	Phase 3	United States;Argentina;Belgium;China;Colombia;Germany;Greece;Ireland;Israel;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Russian Federation;South Africa;Spain;Turkey;Ukraine;United Kingdom
13	NCT01474109 (ClinicalTrials.gov)	December 2011	31/10/2011	Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients	Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic Sclerosis	Systemic Sclerosis;Ulcers	Drug: macitentan 3mg;Drug: macitentan 10mg;Drug: placebo	Actelion	NULL	Completed	18 Years	N/A	All	289	Phase 3	United States;Australia;Belarus;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Denmark;Finland;Germany;Hungary;India;Italy;Poland;Russian Federation;Ukraine
14	EUCTR2010-022710-77-BG (EUCTR)	17/11/2011	26/08/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany
15	EUCTR2010-022969-95-DE (EUCTR)	09/08/2011	31/01/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand
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	EUCTR2010-022710-77-DE (EUCTR)	16/06/2011	31/01/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	285		United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
17	EUCTR2010-022969-95-ES (EUCTR)	26/05/2011	18/11/2011	A clinical research study with macintentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma).	Prospective, randommized, placebo-controlled, double-blind, multicenter, parallel, group study to assess th eefficacy, safety and tolerability of macitentan i patients with ischemic digital ulcers associated with systemic sclerosis. - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis.	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	295		Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand
18	EUCTR2010-022710-77-DK (EUCTR)	22/03/2011	03/02/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	295		United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany
19	EUCTR2010-022710-77-HU (EUCTR)	28/02/2011	01/02/2011	A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)	Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis	Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	295		United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;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

EUCTR2010-022710-77-CZ
(EUCTR)

06/01/2014

02/02/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis

Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

295

Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

EUCTR2010-022710-77-PL
(EUCTR)

30/05/2012

12/03/2012

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

EUCTR2010-022969-95-PL
(EUCTR)

30/05/2012

12/03/2012

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand

EUCTR2010-022710-77-IT
(EUCTR)

11/04/2012

09/02/2012

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis. - DUAL-1 (Digital Ulcers with mAcitentan in systemic scLerosis)

Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: NA
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: NA

ACTELION PHARMACEUTICALS LTD.

NULL

Not Recruiting

Female: yes
Male: yes

285

United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;Hungary;European Union;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany

EUCTR2010-022969-95-GR
(EUCTR)

02/04/2012

28/03/2012

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2010-022969-95-NL
(EUCTR)

27/02/2012

12/12/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis

Ischemic digital ulcers associated with systemic sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand

EUCTR2010-022969-95-PT
(EUCTR)

03/02/2012

12/12/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

United States;Portugal;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand

EUCTR2010-022969-95-BE
(EUCTR)

16/01/2012

29/11/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

Phase 3

Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand

EUCTR2010-022710-77-FI
(EUCTR)

10/01/2012

07/12/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany

EUCTR2010-022969-95-GB
(EUCTR)

21/12/2011

27/01/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

295

Phase 3

Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2010-022969-95-IE
(EUCTR)

07/12/2011

31/01/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

295

Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand

NCT01474122
(ClinicalTrials.gov)

December 2011

31/10/2011

Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients

Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic Sclerosis

Digital Ulcers

Drug: Macitentan 3 mg;Drug: Macitentan 10 mg;Drug: Placebo

Actelion

NULL

Terminated

18 Years

N/A

All

265

Phase 3

United States;Argentina;Belgium;China;Colombia;Germany;Greece;Ireland;Israel;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Russian Federation;South Africa;Spain;Turkey;Ukraine;United Kingdom

NCT01474109
(ClinicalTrials.gov)

December 2011

31/10/2011

Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients

Systemic Sclerosis;Ulcers

Drug: macitentan 3mg;Drug: macitentan 10mg;Drug: placebo

Actelion

NULL

Completed

18 Years

N/A

All

289

Phase 3

United States;Australia;Belarus;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Denmark;Finland;Germany;Hungary;India;Italy;Poland;Russian Federation;Ukraine

EUCTR2010-022710-77-BG
(EUCTR)

17/11/2011

26/08/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany

EUCTR2010-022969-95-DE
(EUCTR)

09/08/2011

31/01/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2010-022710-77-DE
(EUCTR)

16/06/2011

31/01/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

285

United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany

EUCTR2010-022969-95-ES
(EUCTR)

26/05/2011

18/11/2011

A clinical research study with macintentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma).

Prospective, randommized, placebo-controlled, double-blind, multicenter, parallel, group study to assess th eefficacy, safety and tolerability of macitentan i patients with ischemic digital ulcers associated with systemic sclerosis. - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis.

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

295

Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand

EUCTR2010-022710-77-DK
(EUCTR)

22/03/2011

03/02/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

295

United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany

EUCTR2010-022710-77-HU
(EUCTR)

28/02/2011

01/02/2011

A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma)

Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan
Product Name: macitentan
Product Code: macitentan
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

295

United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany