DDrare: Database of Drug Development for Rare Diseases

Searched query = "Idiopathic interstitial pneumonia", "IIPs", "Idiopathic pulmonary fibrosis", "IPF", "Usual interstitial pneumonia", "UIP", "Non-specific interstitial pneumonia", "NSIP", "Acute interstitial pneumonia", "AIP", "Diffuse alveolar damage", "DAD", "COP", "Organizing pneumonia", "OP", "Desquamative interstitial pneumonia", "DIP", "Respiratory bronchiolitis - associated interstitial lung disease", "RB-ILD", "Lymphocytic interstitial pneumonia", "LIP"
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 = (18)F-FDG; 18F-FDG; 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt; 534-1508; 68Ga-BMV101; ACETYLCYSTEINE; ACT-064992; ACT-064992 (macitentan); ART-123; AZAPRED; Acetate; Acetylcysteine; Acetylcysteine Effervescent Tablets; Adult human mesenchymal stem cells; Aerosol interferon-gamma; Air; Alemtuzumab; Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs); Ambrisentan; Antimicrobial therapy: Co-trimoxazole or Doxycycline; Atezolizumab; Autoantibody Reductive Therapy; Autologous Adipose Derived MSCs (ADMSCs); Autologous Stromal Vascular Fraction (SVF); Autologous mesenchymal stem cells derived from bone marrow; Aviptadil; Aviptadil, 66 microgram/mL; Azathioprine; Azathioprine/prednisone; Azithromycin; BBT-877, Multiple doses; BBT-877, Single dose; BG00011; BI 1015550; BIBF 1120; BIBF 1120 ES; BIBF1120; BLD-2660; BMS-986020; BMS-986278; BOSENTAN; Bardoxolone; Bardoxolone methyl; Beclometasone dipropionate; Bevacizumab; Blood sample collection; Bone marrow mesenchymal stem cells; Bosentan; C21; CBDCA; CC; CC-90001; CC-930; CD3/CD19 negative hematopoietic stem cells; CNC; CNTO 888 1 mg/kg; CNTO 888 15 mg/kg; CNTO 888 5 mg/kg; CNTO888; CO; CO-TRIMOXAZOLE; COMPOUND 21; Carbon; Carbon monoxide; Carboplatin; Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03); Co-trimoxazole; Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids; Corticosteroid (prednisolone); Cotrimoxazole; Cravit; Cromoglicate; Cromoglicato disodico; Cromoglycate; Cromolyn; Cromolyn Sodium; Cromolyn sodio (cromoglicato disodico, DSCG); Cromolyn sodium [Disodium Cromoglycate]; Cyclophosphamide; Cyclosphamine; Cysteine; DEX284; DPA; Dabigatran; Dasatinib; Dasatinib + Quercetin; Device: Auto-titrating oxygen system; Device: Centricyte 1000; Device: MRI; Device: Oxymizer® compared to CNC; Dextromethorphan; Diagnostic Test: Metabolomics; Diagnostic Test: PET Imaging; Disodium Cromoglycate [cromolyn sodium]; Disodium cromoglycate (DSCG); Doxycycline; EGCG; ENDOXAN; ESBRIET; EZ-2053; EZ-2053 5mg/kg; Endobronchial infusion of adult mesenchymal stem cells; Endoxan; Epigallocatechin; Epigallocatechin-3-gallate (EGCG); Erivedge; Esbriet; Esbriet® (Pirfenidon); Etanercept; Etoposide; FG-3019; FG-3019 10mg/mL in 10 mL vials; FLUORINE (18F) FLUDEOXYGLUCOSE; Fludarabine; Fludeoxyglucose; Fluimucil; Fluimucil® 600 mg effervescent tablets; Formoterol; Formoterol fumarate dihydrate; Fostair; G-CSF; G321605; G451990; GBT440; GBT440 300 mg capsule; GBT440 300 mg tablet; GC1008; GKT137831; GLPG1205; GLPG1690; GLPG1690 600 mg QD; GS-6624; GSK2126458; GSK3008348; GSK3008348 Nebuliser solution; Gallium68-Dota-Noc; Gefapixant; Granulocyte Colony Stimulating Factor; HEC 68498; HEC585; High dose BIBF 1120 twice daily; Humanized anti-alpha v beta 6 mAb; Hydroxyurea; Hyperoxia; Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment; Hyperpolarized 129-Xenon gas; IDL-2965 Oral Capsule; INO; INOmax; INOmax 400ppm mol/mol inhalation gas; IW001; Ifenprodil; Iloprost; Iloprost Inhalation Solution (Ventavis); Imatinib; Imatinib Mesylate (Gleevec); Immukin; Inhaled Nitric Oxide; Inhaled Nitric Oxide - 30 mcg/kg IBW/hr; Inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr; Inhaled TD139; Inhaled carbon monoxide; Inhaled nitric oxide 75 mcg/kg IBW/hr; Inomax; Interferon Gamma; Interferon alpha oral lozenge; Interferon gamma-1b; Interferon gamma-1b (Actimmune); Interferon-alpha lozenges; Interferon-gamma 1b; Intermediate dose BIBF 1120 twice daily; Jaktinib Dihydrochloride Monohydrate 50mg BID and Mimic tablets of jakitinib hydrochloride 75mg BID and Acetylcysteine Effervescent Tablets; Jaktinib Dihydrochloride Monohydrate 75mg BID and Mimic tablets of jakitinib hydrochloride 50mg BID and Acetylcysteine Effervescent Tablets; Jin-shui Huan-xian granule; KD025; L - Antineoplastic and immunomodulating agents; L01 - Antineoplastic agents; L01X - Other antineoplastic agents; L01XE - Protein kinase inhibitors; L01XE31; L01XE31 - Nintedanib; LANREOTIDE ACETATE; LEBRIKIZUMAB; LPA1; Lanreotide; Lansoprazole; Lebrikizumab; Letairis; Letairis 10 mg; Letairis 5 mg; Liberase Enzyme (Roche); Losartan; Low dose BIBF 1120 twice daily; Low dose BIBF1120 once daily; Lung Spheroid Stem Cells 100 million; Lung Spheroid Stem Cells 200 million; Lung stem cells; MACITENTAN; MESNA; MG-S-2525; MONITOR; Macitentan; Medical air; Medical air (sham O2); Mesna; Minocycline; Montelukast; Morphine; Morphine Sulfate; Morphine hydrochloride; Morphine sulfate; Moxifloxacin; Mycophenolate; Mycophenolate mofetil; N-Acetylcysteine, (NAC); N-acetyl cysteine; N-acetylcysteine; NAC; NALBUPHINE HYDROCHLORIDE; ND-L02-s0201; ND-L02-s0201 for injection; NINTEDANIB; NITRIC OXIDE; Na; Nalbuphine; Nalbuphine ER; Nalbuphine Extended-Realease (ER) Tablets; Nalbuphine Extended-Release (ER) Tablets; Nandrolone; Nandrolone Decanoate; Nandrolone decanoate; Nintedanib; Nitric Oxide; Nivolumab; None; OFEV®; ORIN1001; Octreotide; Ofev; Ofev 100 mg capsule; Ofev 150 mg capsule; Omeprazole; Omeprazole (UK licensed generic product); Other: 60% Oxygen; Other: Control; Other: Cough monitor; Other: Medical air; Other: No Intervention: Standard of Care; Other: Oxygen; Other: Oxygen (2Liter/min); Other: Oxygen (4Liter/min); Other: Pulmonary rehabilitation program; Other: Standard of Care; Other: Untreated Cohort; Oxygen; Oxygen 40 %; PA101; PAMREVLUMAB; PBI4050; PD00377 Na-salt; PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714; PIR, S-7701; PIRFENIDONE; PLN-74809; PLN-74809-000; PREDNISOLONE; PRIVIGEN 100mg/ml; PRM-151; PZN 8881655(RochePharma AG); Paclitaxel; Pamrevlumab; Pirfenidone; Pirfenidone and nintedanib; Pirfenidone or nintedanib; Pirfenidoneone; Placebo; Pomalidomide; Pomalidomide (CC-4047; Prednisolone; Prednisone; Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution; Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF); QAX576; Quercetin; RIXATHON 500 mg; RO0220912; RO0280296; RO5490255; RO5490255/F01-02; RVT-1601; RVT-1601 (formerly, PA101B); Radiation: FDG PET scan; Radiation: GSK26346763: ([18F]-FBA-A20FMDV2) IV infusion; Radiation: Knottin tracer; Remicade; Revatio; Revatio 20 mg; Rituximab; Ro 47-0203; SAR156597; SEPTRIN; SILDENAFIL; SM04646; SODIUM CROMOGLICATE; SULFAMETHOXAZOLE; Salbutamol; Saracatinab; Septrin; Sildenafil; Sildenafil (50 mg); Sildenafil Citrate; Sildenafil and Losartan; Simtuzumab; Sirolimus; Sivelestat; Standard Steroid Treatment; Standard of Care; Sterile Normal Saline for Intravenous Use; Sub-Study: Nintedanib; Sub-Study: Pirfenidone; Sulfamethoxazole; Sulfate; Sulphamethoxazole; Symbicort; TBC; TD-1058; TD139; TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A; TR0311; TRACLEER; TRIMETHOPRIM; TRK-250; Tacrolimus; Tetrandrine; Tetrathiomolybdate; Thalidomide; Thalidomide Pharmion; The Standard Steroid Treatment, Plasma Exchange and rituximab; Thiotepa; Thrombomodulin Alfa; Thrombomodulin alfa; Tiotropium; Tipelukast; Tracleer; Traditional Chinese Medicine Formulation; Tralokinumab; Tralokinumab cohort 1; Tralokinumab cohort 2; Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor; Treatment as Usual (TAU); Treprostinil; Treprostinil sodium for inhalation; Trimethoprim; UROMITEXAN; Uromitexan; VAY736; VISMODEGIB; VOLIBRIS; VRP700; Valganciclovir; Vasoactive intestinal peptide; Vismodegib; Volibris; Warfarin; Xenon; ZL-2102; ZSP1603 12.5 mg; ZSP1603 25 mg; ZSP1603 50 mg; ZSP1603 7.5 mg; Zileuton; Ziritaxestat; [18F]-FBA-A20FMDV2; [18F]FP-R01-MG-F2; [68Ga]CBP8; [BG00011]; [RVT-1601 (in precedenza PA101B)]

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	EUCTR2010-024211-13-DE (EUCTR)	20/07/2011	12/04/2011	Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC study	Long term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL	Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 13.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	ACTELION Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	178		Germany;Canada;Turkey;Spain;United States;Sweden;South Africa;Australia;Israel
2	EUCTR2010-024211-13-ES (EUCTR)	27/06/2011	10/11/2011	Study to evaluate if macitentan is safe and tolerable enough to be usedfor treatment of idiopathic pulmonary fibrosis, following the MUSICstudy	Long term, single-arm, open-label extension study of the MUSIC study toassess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL	Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	ACTELION Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	178		Germany;Canada;Turkey;Spain;United States;Sweden;South Africa;Australia;Israel
3	EUCTR2010-024211-13-SI (EUCTR)	13/06/2011	11/07/2011	Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC study	Long term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL	Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	ACTELION Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	178		United States;Slovenia;Canada;Spain;Turkey;Australia;Israel;South Africa;Germany;Sweden
4	EUCTR2010-024211-13-SE (EUCTR)	26/05/2011	05/04/2011	Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC study	Long term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL	Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 13.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	ACTELION Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	178		Germany;Canada;Turkey;Spain;United States;South Africa;Australia;Sweden;Israel
5	EUCTR2008-006054-17-IT (EUCTR)	26/01/2010	22/10/2009	A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC	A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC	Idiopathic Pulmonary Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10021240	Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan	Actelion Pharamceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	156		Germany;Slovenia;France;Spain;Italy;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2008-006054-17-SE (EUCTR)	12/08/2009	25/06/2009	A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC	A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC	To evaluate the efficacy, safety, and tolerabilitiy of macitentan in patients with idiopathic pulmonary fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis	Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	156		Germany;Slovenia;France;Spain;Italy;Sweden
7	EUCTR2008-006054-17-ES (EUCTR)	20/05/2009	01/04/2009	Estudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia, seguridad y tolerabilidad de Macitentan en pacientes con Fibrosis Pulmonar Idiopática.A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC	Estudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia, seguridad y tolerabilidad de Macitentan en pacientes con Fibrosis Pulmonar Idiopática.A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC	Evaluar la eficacia, seguridad y tolerabilidad de Macitentan en pacientes con Fibrosis Pulmonar Idiopática. MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis	Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	156		Germany;Slovenia;France;Spain;Italy;Sweden
8	NCT00903331 (ClinicalTrials.gov)	May 2009	14/5/2009	Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study	A Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis	Idiopathic Pulmonary Fibrosis	Drug: ACT-064992 (macitentan);Drug: Placebo	Actelion	NULL	Completed	18 Years	N/A	All	178	Phase 2	United States;Australia;Canada;France;Germany;Israel;Italy;Slovenia;South Africa;Spain;Sweden;Turkey
9	EUCTR2008-006054-17-FR (EUCTR)	29/04/2009	25/03/2009	MUSIC: Macitentan USe in an Idiopathic pulmonary fibrosis Clinical studyA double-blind, randomized, placebo-controlled, multicenter, parallel group studyto evaluate the efficacy, safety, and tolerability of macitentan in patients withidiopathic pulmonary fibrosis - MUSIC	MUSIC: Macitentan USe in an Idiopathic pulmonary fibrosis Clinical studyA double-blind, randomized, placebo-controlled, multicenter, parallel group studyto evaluate the efficacy, safety, and tolerability of macitentan in patients withidiopathic pulmonary fibrosis - MUSIC	to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis	Product Name: ACT-064992 Product Code: ACT-064992 INN or Proposed INN: MACITENTAN	Actelion Pharmaceuticals Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	156		Germany;Slovenia;France;Spain;Italy;Sweden
10	EUCTR2008-006054-17-SI (EUCTR)	31/03/2009	06/04/2009	A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC	A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC	To evaluate the efficacy, safety, and tolerabilitiy of macitentan in patients with idiopathic pulmonary fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis	Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	156		Germany;Slovenia;France;Spain;Italy;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	EUCTR2008-006054-17-DE (EUCTR)		05/03/2009	A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC	A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC	To evaluate the efficacy, safety, and tolerabilitiy of macitentan in patients with idiopathic pulmonary fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis	Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan	Actelion Pharmaceuticals Ltd.	NULL	Not Recruiting			Female: yes Male: yes	156		France;Slovenia;Spain;Germany;Italy;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

EUCTR2010-024211-13-DE
(EUCTR)

20/07/2011

12/04/2011

Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC study

Long term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL

Patients with Idiopathic Pulmonary Fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan

ACTELION Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

178

Germany;Canada;Turkey;Spain;United States;Sweden;South Africa;Australia;Israel

EUCTR2010-024211-13-ES
(EUCTR)

27/06/2011

10/11/2011

Study to evaluate if macitentan is safe and tolerable enough to be usedfor treatment of idiopathic pulmonary fibrosis, following the MUSICstudy

Long term, single-arm, open-label extension study of the MUSIC study toassess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL

Patients with Idiopathic Pulmonary Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan

ACTELION Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

178

Germany;Canada;Turkey;Spain;United States;Sweden;South Africa;Australia;Israel

EUCTR2010-024211-13-SI
(EUCTR)

13/06/2011

11/07/2011

Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC study

Long term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL

Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan

ACTELION Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

178

United States;Slovenia;Canada;Spain;Turkey;Australia;Israel;South Africa;Germany;Sweden

EUCTR2010-024211-13-SE
(EUCTR)

26/05/2011

05/04/2011

Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC study

Long term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL

Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan

ACTELION Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

178

Germany;Canada;Turkey;Spain;United States;South Africa;Australia;Sweden;Israel

EUCTR2008-006054-17-IT
(EUCTR)

26/01/2010

22/10/2009

A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC

Idiopathic Pulmonary Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10021240

Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan

Actelion Pharamceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

156

Germany;Slovenia;France;Spain;Italy;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

EUCTR2008-006054-17-SE
(EUCTR)

12/08/2009

25/06/2009

To evaluate the efficacy, safety, and tolerabilitiy of macitentan in patients with idiopathic pulmonary fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis

Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

156

Germany;Slovenia;France;Spain;Italy;Sweden

EUCTR2008-006054-17-ES
(EUCTR)

20/05/2009

01/04/2009

Estudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia, seguridad y tolerabilidad de Macitentan en pacientes con Fibrosis Pulmonar Idiopática.A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC

Evaluar la eficacia, seguridad y tolerabilidad de Macitentan en pacientes con Fibrosis Pulmonar Idiopática.
MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis

Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

156

Germany;Slovenia;France;Spain;Italy;Sweden

NCT00903331
(ClinicalTrials.gov)

May 2009

14/5/2009

Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study

A Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis

Drug: ACT-064992 (macitentan);Drug: Placebo

Actelion

NULL

Completed

18 Years

N/A

All

178

Phase 2

United States;Australia;Canada;France;Germany;Israel;Italy;Slovenia;South Africa;Spain;Sweden;Turkey

EUCTR2008-006054-17-FR
(EUCTR)

29/04/2009

25/03/2009

MUSIC: Macitentan USe in an Idiopathic pulmonary fibrosis Clinical studyA double-blind, randomized, placebo-controlled, multicenter, parallel group studyto evaluate the efficacy, safety, and tolerability of macitentan in patients withidiopathic pulmonary fibrosis - MUSIC

to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis

Product Name: ACT-064992
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN

Actelion Pharmaceuticals Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

156

Germany;Slovenia;France;Spain;Italy;Sweden

EUCTR2008-006054-17-SI
(EUCTR)

31/03/2009

06/04/2009

Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

156

Germany;Slovenia;France;Spain;Italy;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

EUCTR2008-006054-17-DE
(EUCTR)

05/03/2009

Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan

Actelion Pharmaceuticals Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

156

France;Slovenia;Spain;Germany;Italy;Sweden