BOSENTAN ( DrugBank: Bosentan )
10 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 41 | 巨細胞性動脈炎 | 2 |
| 47 | バージャー病 | 1 |
| 51 | 全身性強皮症 | 22 |
| 84 | サルコイドーシス | 4 |
| 85 | 特発性間質性肺炎 | 28 |
| 86 | 肺動脈性肺高血圧症 | 109 |
| 88 | 慢性血栓塞栓性肺高血圧症 | 13 |
| 210 | 単心室症 | 4 |
| 211 | 左心低形成症候群 | 1 |
| 212 | 三尖弁閉鎖症 | 1 |
41. 巨細胞性動脈炎
臨床試験数 : 131 / 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 125
| 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 | NCT03841734 (ClinicalTrials.gov) | March 2019 | 5/2/2019 | Study of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBO | Study of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBO | Arteritis, Giant Cell;Blindness and Low Vision | Drug: treatment | Centre Hospitalier Universitaire de Nice | NULL | Not yet recruiting | 50 Years | N/A | All | 8 | Phase 3 | France |
| 2 | EUCTR2018-004072-35-FR (EUCTR) | 13/02/2019 | 06/11/2018 | Study of the value of early treatment in patients with sudden blindness | Study of the value of early treatment with an endothelin inhibitor (Bosentan) in patients with sudden blindness secondary to giant cell arteritis - CECIBO | giant cell arteritis MedDRA version: 20.0;Level: PT;Classification code 10003232;Term: Arteritis coronary;System Organ Class: 10007541 - Cardiac disorders ;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Trade Name: BOSENTAN MYLAN Product Name: BOSENTAN MYLAN | CHU de Nice | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 8 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France |
47. バージャー病
臨床試験数 : 9 / 薬物数 : 14 - (DrugBank : 7) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 16
| 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 | NCT01447550 (ClinicalTrials.gov) | January 2009 | 5/10/2011 | Treatment of Thromboangiitis Obliterans (Buerguer's Disease) With Bosentan | Treatment of Thromboangiitis Obliterans (Buerger's Disease) With Bosentan | Thromboangiitis Obliterans | Drug: Bosentan | Hospital Universitario Getafe | NULL | Completed | 18 Years | 65 Years | Both | 12 | N/A | Spain |
51. 全身性強皮症
臨床試験数 : 525 / 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
| 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 | NCT03053739 (ClinicalTrials.gov) | December 2016 | 29/12/2016 | To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis | Randomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis | Associated Pulmonary Arterial Hypertension | Drug: Sildenafil 20mg and Bosentan 62.5mg;Drug: Sildenafil 20mg and Placebo | Postgraduate Institute of Medical Education and Research | NULL | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | India |
| 2 | NCT02798055 (ClinicalTrials.gov) | September 30, 2016 | 3/6/2016 | Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis | A National, Observational, Multi-center Registry to Examine the Characteristics of Patients With Systematic Sclerosis Digital Ulcers and Assess Bosentan Treatment. | Systematic Sclerosis;Digital Ulcer;Scleroderma | Drug: Bosentan group | Elpen Pharmaceutical Co. Inc. | NULL | Completed | 18 Years | 80 Years | All | 148 | Greece | |
| 3 | EUCTR2014-002796-28-NL (EUCTR) | 12/04/2016 | 23/04/2015 | Does therapy with bosentan tablets have positive effects on the stiffness of the vessels in patients with scleroderma who have ulcers of the fingers of toes? | The Clinical Efficacy And Subclinical Effects on arterial STIFFNESS of bosentan therapy added to usual care in patients with systemic sclerosis with digital ulcers. - CEASE STIFFNESS | Systemic sclerosis (SSc) is characterized by skin fibrosis and visceral disease, mainly of the lungs, kidneys and the heart, accompanied by microvascular damage ultimately leading to digital ischemia. Digital ischaemia, digital ulceration (DU) or amputation are well-known manifestations of SSc. Still over 50% of the SSc patients suffer from DU. Despite effort and treatment modalities that have emerged, DU remain an important complication in SSc, even in those with mild disease.;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Tracleer INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | University Medical Center Groningen (UMCG) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 4 | NCT02480335 (ClinicalTrials.gov) | June 26, 2015 | 15/6/2015 | The Clinical And Subclinical Effects on Arterial Stiffness of Bosentan in Patients With Systemic Sclerosis | The Clinical Efficacy And Subclinical Effects on Arterial STIFFNESS of Bosentan Therapy Added to Usual Care in Patients With Systemic Sclerosis With Digital Ulcers | Scleroderma, Systemic | Drug: bosentan | University Medical Center Groningen | Actelion | Completed | 18 Years | N/A | All | 20 | Phase 4 | Netherlands |
| 5 | JPRN-JapicCTI-132176 | 01/6/2013 | Bosentan DU | A prospective, multicenter, single arm, open-label, phase III study to assess the safety and efficacy of bosentan in patients with digital ulcers associated with systemic sclerosis (SSc) | Digital ulcers associated with systemic sclerosis | Intervention name : Ro47-0203 / ACT-050088 INN of the intervention : Bosentan Dosage And administration of the intervention : Total Daily dose should be 125 mg and bosentan tablet 62.5 mg should be given twice daily (b.i.d.) after meal in the morning and evening for the first four weeks. If tolerable, the daily dosage can be increased up to 250 mg (125 mg b.i.d) from Week 5. Control intervention name : null | Actelion Pharmaceuticals Japan Ltd. | NULL | 18 | BOTH | 20 | Phase 3 | NULL | |||
| 6 | EUCTR2011-005303-32-NL (EUCTR) | 05/03/2012 | 26/01/2012 | The effect of bosentan in scleroderma patients with a specific nailfold pattern (HOME II) | Effects of bosentan in a HOMogenEous population of SSc subjects with an early or active SSc nailfold capillaroscopic pattern (HOME II) - HOME II | Digital Ulcera in Systemic Sclerodermia patients MedDRA version: 14.1;Level: PT;Classification code 10053400;Term: Endothelin increased;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Tracleer INN or Proposed INN: Bosentan | Actelion Pharmaceuticals Nederland bv | NULL | Not Recruiting | Female: yes Male: yes | Netherlands | ||||
| 7 | NCT01395732 (ClinicalTrials.gov) | March 2011 | 6/7/2011 | Bosentan in Systemic Sclerosis | Effects of Bosentan in a Homogenous Population of Systemic Sclerosis Subjects With a Predefined Restriction of Blood Flow in the Hands | Systemic Sclerosis;Digital Ulcers | Drug: Bosentan | Actelion | NULL | Completed | 18 Years | N/A | Both | 18 | Phase 4 | Netherlands |
| 8 | NCT01241383 (ClinicalTrials.gov) | December 2010 | 12/11/2010 | Effect of Bosentan in Scleroderma Renal Crisis | Effect of Bosentan in the Course of Scleroderma Renal Crisis | Scleroderma Renal Crisis | Drug: Bosentan | Assistance Publique - Hôpitaux de Paris | Actelion | Completed | 18 Years | N/A | Both | 16 | Phase 2 | France |
| 9 | EUCTR2010-021452-26-FR (EUCTR) | 20/09/2010 | 09/07/2010 | Crise Rénale sclérodermique : amélioration du pronostic par adjonction de Bosentan au traitement de référence de la maladie - SCSREINBO | Crise Rénale sclérodermique : amélioration du pronostic par adjonction de Bosentan au traitement de référence de la maladie - SCSREINBO | Les patients inclus dans l'étude seront des patients atteints de sclérodermie systémique (définie selon les critères de la classification de l'ACR et/ou de Leroy et Medsger) et présentant une crise rénale sclérodermique aigue définie par une HTA sévère d'emblée et/ou d'aggravation progressive >150/85mmHg obtenue à deux reprises minimum en 24H, sans autre explication que la ScS et/ou une insuffisance rénale rapidement progressive, sans autre explication que la ScS. MedDRA version: 8.1;Level: PT;Classification code 10062553;Term: scleroderma renal crisis | Trade Name: Tracleer Product Name: Tracleer INN or Proposed INN: bosentan Trade Name: Tracleer Product Name: Tracleer INN or Proposed INN: Bosentan | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | France | |||
| 10 | NCT00909337 (ClinicalTrials.gov) | January 2008 | 27/5/2009 | Early Therapy of Pulmonary Arterial Hypertension | Early Therapy of Pulmonary Arterial Hypertension | Pulmonary Hypertension;Systemic Sclerosis | Drug: Bosentan | Medical University of Graz | Actelion | Completed | 18 Years | 90 Years | Both | 10 | N/A | Austria |
| 11 | NCT00377455 (ClinicalTrials.gov) | September 2006 | 14/9/2006 | Placebo Controlled Trial of Bosentan in Scleroderma Patients | Placebo Controlled Trial of Bosentan vs Placebo in NYHA Class I/II Scleroderma Patients With Exercise Induced Pulmonary Hypertension | Systemic Scleroderma;Pulmonary Hypertension | Drug: Bosentan;Drug: Placebo | Georgetown University | Actelion | Terminated | 18 Years | N/A | All | 5 | Phase 2 | United States |
| 12 | NCT00318175 (ClinicalTrials.gov) | June 2006 | 24/4/2006 | Effect of Bosentan on Skin Fibrosis in Patients With Systemic Sclerosis | Study to Assess the Effect of Bosentan on the Treatment of Skin Fibrosis in Patients With Systemic Sclerosis (BTSF) | Systemic Scleroderma;Skin Fibrosis;Hand Functionality | Drug: Bosentan (Tracleer) | Heinrich-Heine University, Duesseldorf | NULL | Completed | 18 Years | N/A | Both | 10 | Phase 2 | Germany |
| 13 | EUCTR2005-000701-61-GB (EUCTR) | 29/11/2005 | 27/10/2005 | An open label trial of the dual specificity endothelin receptor antagonist bosentan in established scleroderma renal crisis - BIRD-1 | An open label trial of the dual specificity endothelin receptor antagonist bosentan in established scleroderma renal crisis - BIRD-1 | Scleroderma renal crisis | Trade Name: Tracleer Product Name: Bosentan Product Code: N/A | University College London | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): | United Kingdom | ||
| 14 | EUCTR2004-000632-82-IT (EUCTR) | 06/04/2005 | 15/03/2007 | Long term open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers | Long term open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers | Healing and prevention of ischemic digital ulcers in patients with systemic sclerosis Level: PTClassification code 10059084 | Trade Name: TRACLEER*56CPR RIV 125MG INN or Proposed INN: Bosentan | ACTELION PHARMACEUTICALS ITALIA | NULL | Not Recruiting | Female: yes Male: yes | 180 | Italy | |||
| 15 | NCT00226889 (ClinicalTrials.gov) | January 2005 | 23/9/2005 | Treatment of Early Systemic Sclerosis by Bosentan | Systemic Sclerosis (Scleroderma) | Drug: bosentan | Rikshospitalet University Hospital | NULL | Terminated | 18 Years | 70 Years | Both | 30 | Phase 1/Phase 2 | Norway | |
| 16 | EUCTR2004-000632-82-GB (EUCTR) | 16/09/2004 | 11/02/2005 | Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension | Long term bosentan open label extension of the RAPIDS-2 study in Systemic Sclerosis patients with ischemic digital ulcers - RAPIDS-2 Open label extension | SSc is a multi-system disorder of unknown etiology characterized by fibrosis and vascular obliteration in the skin and visceral organs. The pathogenesis of SSc involves immunologic mechanisms vascular damage and excessive accumulation of fibrosis in the skin and internal organs. As vascular damage progresses the microvascular bed in the skin and other sites is impaired, producing a state of chronic ischemia. SSc is commonly divided into the diffuse and limited form of the disease | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Italy;United Kingdom | ||
| 17 | EUCTR2004-000631-28-IT (EUCTR) | 14/09/2004 | 17/09/2004 | Bosentan use in interstitial lung disease (open label). Long-term open-label study in patients with interstitial lung disease associated with systemic sclerosis who completed the protocol AC-052-330/BUILD 2. | Bosentan use in interstitial lung disease (open label). Long-term open-label study in patients with interstitial lung disease associated with systemic sclerosis who completed the protocol AC-052-330/BUILD 2. | Interstitial lung disease associated with systemic sclerosis | Trade Name: TRACLEER*125MG 56CPR RIV. Product Name: NA Product Code: NA INN or Proposed INN: Bosentan | ACTELION PHARMACEUTICALS ITALIA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 18 | NCT00319696 (ClinicalTrials.gov) | July 8, 2004 | 27/4/2006 | Bosentan in Digital Ulcers | Long-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital Ulcers | Digital Ulcers | Drug: Bosentan 62.5 mg;Drug: Bosentan 125 mg | Actelion | NULL | Completed | 18 Years | N/A | All | 116 | Phase 3 | United States;Austria;Canada;France;Germany;Italy;Switzerland;United Kingdom |
| 19 | NCT00319033 (ClinicalTrials.gov) | July 2004 | 26/4/2006 | Open-label Study With Bosentan in Interstitial Lung Disease | Long-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330. | Interstitial Lung Disease;Scleroderma | Drug: bosentan | Actelion | NULL | Completed | 18 Years | N/A | Both | 132 | Phase 2/Phase 3 | United States;Canada;France;Germany;Israel;Italy;Korea, Republic of;Netherlands;Sweden;Switzerland;United Kingdom |
| 20 | NCT02800993 (ClinicalTrials.gov) | October 2003 | 13/6/2016 | Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma | A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis | Systemic Sclerosis;Digital Ulcers | Drug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: Placebo | Actelion | NULL | Completed | 18 Years | N/A | Both | 188 | Phase 3 | United States;Canada |
| 21 | NCT00077584 (ClinicalTrials.gov) | October 2003 | 10/2/2004 | Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma | A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis | Digital Ulcers;Systemic Sclerosis | Drug: Bosentan 62.5 mg;Drug: Bosentan 125 mg;Drug: Placebo | Actelion | NULL | Completed | 18 Years | N/A | Both | 188 | Phase 3 | United States;Canada |
| 22 | NCT00070590 (ClinicalTrials.gov) | July 2003 | 6/10/2003 | Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma | A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis | Pulmonary Fibrosis;Scleroderma, Systemic | Drug: Bosentan | Actelion | NULL | Completed | 18 Years | N/A | Both | 132 | Phase 2/Phase 3 | United States;France;Germany;Israel;Italy;Netherlands;Sweden;Switzerland;United Kingdom |
84. サルコイドーシス
臨床試験数 : 149 / 薬物数 : 202 - (DrugBank : 78) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 169
| 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 | NCT00926627 (ClinicalTrials.gov) | April 2009 | 22/6/2009 | Safety and Efficacy Study of Bosentan in Progressive Pulmonary Sarcoidosis | A Prospective Randomized, Double Blind, Placebo-controlled, Safety and Efficacy Study of Bosentan as add-on Therapy in Progressive Pulmonary Sarcoidosis | Sarcoidosis;Pulmonary Hypertension | Drug: bosentan;Drug: placebo | Daniel Doberer | NULL | Terminated | 18 Years | 70 Years | Both | 32 | Phase 2 | Austria |
| 2 | EUCTR2007-005117-18-AT (EUCTR) | 03/04/2008 | 04/03/2008 | Safety and efficacy study of bosentan in progressive pulmonary sarcoidosis - BOPSAC | Safety and efficacy study of bosentan in progressive pulmonary sarcoidosis - BOPSAC | Progressive pulmonary sarcoidosis MedDRA version: 9.1;Level: PT;Classification code 10037430;Term: Pulmonary sarcoidosis | Trade Name: Tracleer Product Name: Bosentan | Medical University of Vienna, Department of Clinical Pharmacology | NULL | Not Recruiting | Female: yes Male: yes | Austria | ||||
| 3 | NCT00581607 (ClinicalTrials.gov) | April 2008 | 26/12/2007 | Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension | Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension | Sarcoidosis;Pulmonary Arterial Hypertension | Drug: Bosentan;Drug: Placebo | University of Cincinnati | Actelion | Completed | 18 Years | N/A | Both | 43 | Phase 2/Phase 3 | United States |
| 4 | EUCTR2006-005361-19-GB (EUCTR) | 09/03/2007 | 17/12/2006 | Evaluation of the efficacy of the dual endothelin 1 receptor antagonist Bosentan in the treatment of Pulmonary Hypertension secondary to Chronic Obstructive Pulmonary Disease and in the treatment of Pulmonary Hypertension secondary to sarcoidosis | Evaluation of the efficacy of the dual endothelin 1 receptor antagonist Bosentan in the treatment of Pulmonary Hypertension secondary to Chronic Obstructive Pulmonary Disease and in the treatment of Pulmonary Hypertension secondary to sarcoidosis | Pulmonary Hypertension secondary to Chronic Obstructive Pulmonary Disease and secondary to Sarcoid Patients devolop pulmonary hypertension for various reasons, two common causes are Chronic Obstructive Pulmonary disease and Sarcoid. Once developed it may go on to cause right heart failure and severe breathlessness and eventually death. We believe that the use of bosentan may lower the pulmonary hypertension and improve symptoms. MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension | Trade Name: Tracleer Product Name: tracleer INN or Proposed INN: Bosentan monohydrate | St Georges Hospital | NULL | Not Recruiting | Female: yes Male: yes | 45 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom |
85. 特発性間質性肺炎
臨床試験数 : 627 / 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
| 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 | JPRN-UMIN000004749 | 2011/01/01 | 18/12/2010 | A study to evaluate the long-term effect of pulmonary hypertension on prognosis, activities of daily living (ADL), cardiac function and pulmonary function in patients with COPD and idiopathic pulmonary fibrosis (IPF), respectively, according to baseline severity of pulmonary hypertension and the efficacy and safety of the Tracleer (bosentan hydrate) tablet for prognosis, activities of daily living, cardiac function and pulmonary function in patients with COPD and IPF, respectively, according to baseline severity of pulmonary hypertension. | A study to evaluate the long-term effect of pulmonary hypertension on prognosis, activities of daily living (ADL), cardiac function and pulmonary function in patients with COPD and idiopathic pulmonary fibrosis (IPF), respectively, according to baseline severity of pulmonary hypertension and the efficacy and safety of the Tracleer (bosentan hydrate) tablet for prognosis, activities of daily living, cardiac function and pulmonary function in patients with COPD and IPF, respectively, according to baseline severity of pulmonary hypertension. - A study to evaluate the long-term effect of pulmonary hypertension on prognosis, activities of daily living (ADL), cardiac function and pulmonary function in patients with COPD and idiopathic pulmonary fibrosis (IPF), respectively, according to baseline severity of pulmonary hypertension and the efficacy and safety of the Tracleer (bosentan hydrate) tablet for prognosis, activities of daily living, cardiac function and pulmonary function in patients with COPD and IPF, respectively, according to baseline severity of pulmonary hypertension. | Patients with COPD or IPF (WHO functional class II, III or IV), without hypoxia (PaO2 at rest<90mmHg or after 6minutes walk), who provide their informed consent to participate in this study. | Treated subgroup In patients with COPD without hypoxia (PaO2<60mmHg at rest or after 6 minutes walk) (WHO functional class II, III or IV), patients with Pulmonary hypertension with evidense of mPAP at rest=/>35mmHg : 20subjects Bosentan will be administered basically according to the approved dosage and administration, as specified below. However, in this study conducted in accordance with routine clinical practice, the initial dosage may be used continuously if considered appropriate based on the patient's condition. Treatment with bosentan in adults is usually initiated at a dose of 62.5 mg twice daily to be taken orally after breakfast and the evening meal for 4 weeks. From Week 5 of treatment, bosentan is administered at a dose of 125 mg twice daily to be taken orally after breakfast and evening meal. The dosage should be adjusted according to the patient's symptoms and tolerability, but should not exceed 250 mg per day. Duration of study drug administration: 24 months In addition, Interventions/Control 11 and 12 is described in Interventions/control 10. Treated subgroup In patients with COPD without hypoxia (PaO2<60mmHg at rest or after 6 minutes walk) (WHO functional class II, III or IV), patients with boarderline pulmonary hypertension or pulmonary hypertension (mPAP at rest=/>25mmHg and/or mPAP on effort=/>30mmHg) with mPAP at rest<35mmHg: 20subjects Tracleer Tablets will be administered basically according to the approved dosage and administration, as specified below. However, in this study conducted in accordance with routine clinical practice, the initial dosage may be used continuously if considered appropriate based on the patient's condition. Treatment with bosentan in adults is usually initiated at a dose of 62.5 mg twice d | Department of Respiratory Medicine, Chiba-Hokusoh Hospital, Nippon Medical School | NULL | Recruiting | 40years-old | Not applicable | Male and Female | 160 | Not applicable | Japan |
| 2 | EUCTR2007-001741-18-AT (EUCTR) | 02/04/2009 | 07/04/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 3 | EUCTR2007-001741-18-NL (EUCTR) | 17/09/2008 | 30/05/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 4 | EUCTR2007-001741-18-GB (EUCTR) | 25/07/2008 | 11/04/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Belgium;Spain;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 5 | EUCTR2007-001741-18-IE (EUCTR) | 17/07/2008 | 12/03/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | |||
| 6 | EUCTR2007-001741-18-FR (EUCTR) | 24/06/2008 | 04/02/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | France;Czech Republic;Belgium;Spain;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 7 | EUCTR2007-001741-18-CZ (EUCTR) | 16/06/2008 | 18/04/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;United Kingdom;Czech Republic;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 8 | EUCTR2007-001741-18-DE (EUCTR) | 23/05/2008 | 03/11/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | France;Czech Republic;Belgium;Spain;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom | |||
| 9 | EUCTR2007-001741-18-ES (EUCTR) | 21/04/2008 | 12/02/2008 | Estudio de extensión abierta en pacientes con Fibrosis Pulmonar Idiopática que hayan completado el protocolo AC-052-321 / BUILD 3 - BUILD-3-OL | Estudio de extensión abierta en pacientes con Fibrosis Pulmonar Idiopática que hayan completado el protocolo AC-052-321 / BUILD 3 - BUILD-3-OL | Fibrosis Pulmonar Idiopática (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 10 | NCT00631475 (ClinicalTrials.gov) | April 2008 | 12/2/2008 | Open Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321/ BUILD 3 / NCT00391443 | Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 (NCT00391443) | Idiopathic Pulmonary Fibrosis | Drug: Bosentan | Actelion | NULL | Completed | 18 Years | N/A | All | 128 | Phase 3 | United States;Australia;Belgium;Canada;Czech Republic;France;Germany;Ireland;Israel;Italy;Japan;Korea, Republic of;Spain;Switzerland;United Kingdom;Austria;Croatia;Former Serbia and Montenegro;Netherlands;Serbia |
| 11 | NCT00637065 (ClinicalTrials.gov) | April 2008 | 10/3/2008 | Bosentan in Pulmonary Hypertension in Interstitial Lung Disease Treatment Study | Use of the Endothelin-1 Antagonist Bosentan in Patients With Established Pulmonary Hypertension and Fibrotic Lung Disease. - A Randomised, Placebo-Controlled, Double-Blinded Study. | Pulmonary Hypertension;Interstitial Lung Disease;Idiopathic Pulmonary Fibrosis;Nonspecific Interstitial Pneumonia | Drug: Bosentan;Drug: Placebo | Royal Brompton & Harefield NHS Foundation Trust | Actelion | Not yet recruiting | 18 Years | 80 Years | Both | 48 | Phase 4 | United Kingdom |
| 12 | EUCTR2007-001741-18-BE (EUCTR) | 20/03/2008 | 14/03/2008 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 - BUILD-3-OL | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 13 | EUCTR2007-001741-18-IT (EUCTR) | 07/03/2008 | 23/03/2009 | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321/BUILD 3 - Build-3 OL | Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321/BUILD 3 - Build-3 OL | Idipathic Pulmonary Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10001892;Term: Alveolitis fibrosing | Trade Name: TRACLEER INN or Proposed INN: Bosentan | Actelion Registration Ltd | NULL | Not Recruiting | Female: yes Male: yes | 390 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | |||
| 14 | NCT00625469 (ClinicalTrials.gov) | October 2007 | 19/2/2008 | Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan | Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot Study | Pulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis | Drug: bosentan | Rajan Saggar | Actelion | Withdrawn | N/A | N/A | All | 0 | Phase 4 | United States |
| 15 | EUCTR2006-001183-24-IE (EUCTR) | 30/04/2007 | 16/11/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 16 | EUCTR2006-001183-24-GB (EUCTR) | 09/03/2007 | 23/11/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Spain;Belgium;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 17 | EUCTR2006-001183-24-NL (EUCTR) | 06/03/2007 | 10/11/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 18 | EUCTR2006-001183-24-SK (EUCTR) | 26/02/2007 | 19/01/2007 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | France;Czech Republic;Slovakia;Spain;Belgium;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 19 | EUCTR2006-001183-24-DE (EUCTR) | 22/02/2007 | 01/12/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Czech Republic;Spain;Belgium;Ireland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 20 | EUCTR2006-001183-24-ES (EUCTR) | 14/02/2007 | 07/04/2010 | Efectos de Bosentan sobre la morbilidad y mortalidad en pacientes con Fibrosis Pulmonar Idiopática- Estudio fase III, multicéntrico, randomizado, de grupos paralelos, doble ciego, controlado con placebo, secuencial por grupos, condicionado por acontecimientos.English:Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Efectos de Bosentan sobre la morbilidad y mortalidad en pacientes con Fibrosis Pulmonar Idiopática- Estudio fase III, multicéntrico, randomizado, de grupos paralelos, doble ciego, controlado con placebo, secuencial por grupos, condicionado por acontecimientos.English:Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Spanish:Fibrosis Pulmonar IdiopáticaEnglish:Idiopathic Pulmonary Fibrosis MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Czech Republic;Slovakia;Belgium;Spain;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 21 | EUCTR2006-001183-24-CZ (EUCTR) | 07/02/2007 | 21/12/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 22 | NCT00391443 (ClinicalTrials.gov) | February 2007 | 20/10/2006 | BUILD 3: Bosentan Use in Interstitial Lung Disease | Effects of Bosentan on Morbidity and Mortality in Patients With Idiopathic Pulmonary Fibrosis - a Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Group Sequential, Phase III Study. | Idiopathic Pulmonary Fibrosis | Drug: Bosentan;Drug: Placebo | Actelion | NULL | Completed | 18 Years | N/A | All | 616 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Croatia;Czech Republic;France;Germany;Ireland;Israel;Italy;Japan;Korea, Republic of;Netherlands;Serbia;Spain;Switzerland;United Kingdom;Denmark;Former Serbia and Montenegro;Slovakia |
| 23 | EUCTR2006-001183-24-DK (EUCTR) | 24/01/2007 | 12/12/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;France;Spain;Ireland;Italy;Austria | ||
| 24 | EUCTR2006-001183-24-AT (EUCTR) | 10/01/2007 | 11/12/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 25 | EUCTR2006-001183-24-BE (EUCTR) | 12/12/2006 | 14/11/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer Product Name: Bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 26 | EUCTR2006-001183-24-IT (EUCTR) | 11/12/2006 | 05/01/2007 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD 3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD 3 | Patients with Idiopathic pulmonary fibrosis Level: PTClassification code 10037383 | Trade Name: TRACLEER | Actelion Pharmaceuticals LTD | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 27 | NCT00071461 (ClinicalTrials.gov) | August 2003 | 23/10/2003 | Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis | A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Idiopathic Pulmonary Fibrosis, Open Label Extension | Idiopathic Pulmonary Fibrosis | Drug: bosentan;Drug: Placebo | Actelion | NULL | Completed | 18 Years | N/A | Both | 158 | Phase 2/Phase 3 | United States;Canada;France;Germany;Israel;Italy;Switzerland;United Kingdom |
| 28 | EUCTR2006-001183-24-FR (EUCTR) | 28/11/2006 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Effects of bosentan on morbidity and mortality in patients with Idiopathic Pulmonary Fibrosis - a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, group sequential, phase III study - BUILD-3 | Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 8.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Tracleer INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer Trade Name: Tracleer INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ACTELION PHARMACEUTICALS LTD | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | France;Czech Republic;Slovakia;Spain;Belgium;Ireland;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom |
86. 肺動脈性肺高血圧症
臨床試験数 : 1,205 / 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
| 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 | NCT04039464 (ClinicalTrials.gov) | August 1, 2022 | 1/7/2019 | Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension | Kids MoD PAH Trial: Mono- vs. Duo-Therapy for Pediatric Pulmonary Arterial Hypertension | Pediatric Pulmonary Hypertension | Drug: Mono-Therapy with Sildenafil;Drug: Duo-Therapy with Sildenafil + Bosentan | Johns Hopkins University | NULL | Recruiting | 4 Months | 18 Years | All | 100 | Phase 3 | United States;Canada |
| 2 | NCT04991207 (ClinicalTrials.gov) | February 6, 2018 | 28/7/2021 | Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Bosentan | An Open-label, Three Period, Fixed Sequence Study to Assess the Effect of a Single Dose of BIA 5 1058 400 mg on the Steady State Pharmacokinetics of Bosentan in Healthy Subjects Under Fasting Conditions | Pulmonary Arterial Hypertension | Drug: BIA 5-1058;Drug: bosentan | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 44 | Phase 1 | Germany |
| 3 | NCT03053739 (ClinicalTrials.gov) | December 2016 | 29/12/2016 | To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis | Randomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis | Associated Pulmonary Arterial Hypertension | Drug: Sildenafil 20mg and Bosentan 62.5mg;Drug: Sildenafil 20mg and Placebo | Postgraduate Institute of Medical Education and Research | NULL | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | India |
| 4 | NCT02885012 (ClinicalTrials.gov) | June 2016 | 3/5/2016 | Crossover Study From Macitentan or Bosentan Over to Ambrisentan | A Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Ambrisentan | Medical University of South Carolina | Ochsner Health System | Terminated | 18 Years | 80 Years | All | 3 | Phase 4 | United States |
| 5 | ChiCTR-OON-17013521 | 2015-02-01 | 2017-11-24 | Transition from ambrisentan to bosentan in pulmonary arterial hypertension: A single center prospective study | Transition from ambrisentan to bosentan in pulmonary arterial hypertension: A single center prospective study | pulmonary arterial hypertension | ambrisentan group:oral ambrisentan;bosentan group:oral bosentan; | Shanghai Pulmonary Hospital | NULL | Completed | Male | ambrisentan group:12;bosentan group:8; | China | |||
| 6 | NCT01827059 (ClinicalTrials.gov) | October 2013 | 5/4/2013 | Bosentan In Exercise Induced Pulmonary Arterial Hypertension in CongenitaL Heart diseasE | A Randomized Placebo Controlled Trial to Analyze Changes in Pulmonary Arterial Pressures at Peak Exercise in Congenital Heart Disease Patients With Exercise-induced Pulmonary Arterial Hypertension Before and After Treatment With Bosentan, Compared to Placebo | Pulmonary Arterial Hypertension;Congenital Heart Disease | Drug: Bosentan;Drug: Placebo | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | NULL | Active, not recruiting | 18 Years | N/A | All | 12 | Phase 2 | Netherlands |
| 7 | JPRN-JapicCTI-132155 | 01/8/2013 | 11/06/2013 | Bosentan extension study for PAH pediatric patients | Open-label, long-term, efficacy, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of Japanese children with pulmonary arterial hypertension who completed the previous study. | Pulmonary arterial hypertension (PAH) | Intervention name : Ro 47-0203 / ACT-050088 INN of the intervention : bosentan Dosage And administration of the intervention : Oral administration, 2 mg/kg b.i.d, Patients are not to receive a dose exceeding 120 mg b.i.d. | Actelion Pharmaceuticals Japan Ltd. | NULL | 14 | BOTH | 5 | Phase 3 | NULL | ||
| 8 | JPRN-JapicCTI-132154 | 01/5/2013 | Bosentan for PAH pediatric patients | Open-label, multicenter study to assess the efficacy, safety, tolerability, and pharmacokinetics of bosentan in Japanese children with pulmonary arterial hypertension | Pulmonary arterial hypertension (PAH) | Intervention name : Ro47-0203 / ACT-050088 INN of the intervention : bosentan Dosage And administration of the intervention : Oral administration, 2 mg/kg b.i.d, Patients are not to receive a dose exceeding 120 mg b.i.d. Control intervention name : null | Actelion Pharmaceuticals Japan Ltd. | NULL | 14 | BOTH | 5 | Phase 3 | NULL | |||
| 9 | NCT03236818 (ClinicalTrials.gov) | May 2013 | 18/3/2013 | Goal Oriented Strategy to Preserve Ejection Fraction Trial | Raising the Bars in the Treatment of Pulmonary Arterial Hypertension: Goal Oriented Strategy to Preserve Ejection Fraction Trial | Pulmonary Arterial Hypertension | Drug: ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan) | VU University Medical Center | NULL | Active, not recruiting | 18 Years | 80 Years | All | 30 | Phase 4 | Netherlands |
| 10 | EUCTR2010-021825-11-BG (EUCTR) | 02/01/2013 | 20/11/2012 | A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855 MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 3 | Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China | ||
| 11 | NCT01712997 (ClinicalTrials.gov) | September 2012 | 22/10/2012 | Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients | Phase ? Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension Patients | Pulmonary Arterial Hypertension | Drug: Iloprost;Drug: Bosentan | Fourth Military Medical University | NULL | Recruiting | 10 Years | 80 Years | Both | 90 | Phase 3 | China |
| 12 | EUCTR2011-004106-16-BG (EUCTR) | 10/08/2012 | 11/06/2012 | A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound | A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | Actelion pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Ukraine;Guatemala;Russian Federation;Chile;Colombia;Vietnam;India;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China | ||
| 13 | EUCTR2011-004612-31-PT (EUCTR) | 06/07/2012 | 02/05/2012 | A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time. | A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | Actelion pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China | |||
| 14 | EUCTR2011-004106-16-PT (EUCTR) | 01/06/2012 | 28/02/2012 | A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound | A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | Actelion pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China | |||
| 15 | EUCTR2010-021793-12-NL (EUCTR) | 09/11/2011 | 14/02/2011 | A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | Pulmonary arterial hypertension (PAH) in children MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Czech Republic;Hungary;Spain;Germany;Netherlands;Italy | |||
| 16 | NCT01548950 (ClinicalTrials.gov) | September 2011 | 5/3/2012 | Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension | Combined Clinical and Surgical Approaches to Congenital Heart Disease Associated With Pulmonary Arterial Hypertension (PAH-CHD) | Congenital Heart Disease;Pulmonary Arterial Hypertension | Drug: Sildenafil singly or in association with Bosentan | University of Sao Paulo General Hospital | Instituto do Coracao;Fundação de Amparo à Pesquisa do Estado de São Paulo | Completed | 2 Months | N/A | All | 50 | N/A | Brazil |
| 17 | NCT01330108 (ClinicalTrials.gov) | May 2011 | 4/4/2011 | Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension | Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension | Pulmonary Arterial Hypertension | Drug: ambrisentan | University of Alabama at Birmingham | NULL | Completed | 19 Years | N/A | All | 32 | Phase 4 | United States |
| 18 | EUCTR2010-021793-12-ES (EUCTR) | 28/04/2011 | 03/03/2011 | Estudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar | Estudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar | Hipertensión arterial pulmonar (PAH) en niños. MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película INN or Proposed INN: BOSENTAN MONOHIDRATO Other descriptive name: BOSENTAN MONOHIDRATO | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Czech Republic;Hungary;Spain;Netherlands;Germany;Italy | |||
| 19 | EUCTR2010-021825-11-NL (EUCTR) | 28/04/2011 | 03/11/2010 | A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Germany;Netherlands;China | |||
| 20 | NCT01392469 (ClinicalTrials.gov) | April 20, 2011 | 10/5/2011 | Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants | A Non-Randomized, Multiple Dose, Three Treatment Period, Open-Label, Single Sequence, Single Group Study to Evaluate the Pharmacokinetic Effect of Two Doses of QTI571 (Imatinib) on the Co-administered Drugs Sildenafil and Bosentan in Pulmonary Arterial Hypertension (PAH) Patients | Pulmonary Arterial Hypertension | Drug: Imatinib;Drug: Sildenafil;Drug: Bosentan | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 21 | Phase 3 | United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Romania;Turkey |
| 21 | EUCTR2010-021793-12-IT (EUCTR) | 10/04/2011 | 16/05/2011 | A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Study Extension | A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Study Extension | Pulmonary Arterial Hypertension MedDRA version: 13.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 13.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: TRACLEER INN or Proposed INN: Bosentan | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Czech Republic;Hungary;Spain;Netherlands;Germany;Italy | |||
| 22 | EUCTR2010-021793-12-DE (EUCTR) | 04/04/2011 | 01/02/2011 | A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a day | A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | Pulmonary arterial hypertension (PAH) in children MedDRA version: 16.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855 MedDRA version: 16.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;South Africa;Germany;Netherlands;China | |||
| 23 | JPRN-UMIN000005464 | 2011/04/01 | 19/04/2011 | Drug interactions and effects of combination therapy for pulmonary arterial hypertension | Drug interactions and effects of combination therapy for pulmonary arterial hypertension - Drug interactions and effects of PAH combination therapy | pulmonary arterial hypertension | phase 1: sildenafil (60mg/day) and bosentan (250mg/day) for 4 or 5 weeks phase 2: sildenafil(60mg/day) and ambrisentan (5mg/day) for 4 or 5 weeks phase 3: tadalafil (40mg/day) and ambrisentan (5mg/day) for 4 or 5 weeks | Hamamatsu University School of Medicine | University of Shizuoka | Recruiting | 20years-old | Not applicable | Male and Female | 15 | Not applicable | Japan |
| 24 | EUCTR2010-021793-12-CZ (EUCTR) | 09/03/2011 | 04/02/2011 | A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a day | A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;South Africa;Netherlands;Germany;China | |||
| 25 | NCT01338415 (ClinicalTrials.gov) | March 8, 2011 | 15/4/2011 | FUTURE 3 Study Extension | A Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Bosentan | Actelion | NULL | Completed | 3 Months | 12 Years | All | 58 | Phase 3 | United States;Australia;Belarus;China;Czechia;France;Germany;Hungary;India;Israel;Italy;Mexico;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;Czech Republic;Netherlands |
| 26 | NCT01223352 (ClinicalTrials.gov) | March 8, 2011 | 12/10/2010 | Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension | An Open-label, Prospective Multicenter Study to Assess the Pharmacokinetics, Tolerability, Safety and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: bosentan | Actelion | NULL | Completed | 3 Months | 12 Years | All | 64 | Phase 3 | United States;Australia;Belarus;China;Czechia;France;Germany;Hungary;India;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;Czech Republic |
| 27 | EUCTR2010-021793-12-HU (EUCTR) | 28/02/2011 | 02/02/2011 | A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a day | A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | Pulmonary arterial hypertension (PAH) in children MedDRA version: 16.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855 MedDRA version: 16.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | South Africa;Netherlands;Germany;China;United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia | |||
| 28 | ChiCTR-ONC-11001799 | 2011-02-17 | 2011-12-15 | A single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease | A single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease | pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease | All groups:Bosentan therapy ; | Beijing Anzhen Hospital | NULL | Completed | 0 | 18 | Both | All groups:50; | China | |
| 29 | EUCTR2010-021344-17-IT (EUCTR) | 28/01/2011 | 07/02/2011 | A non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - ND | A non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - ND | Pulmonary arterial hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911 | Trade Name: GLIVEC INN or Proposed INN: IMATINIB MESYLATE Trade Name: REVATIO INN or Proposed INN: Sildenafil Trade Name: TRACLEER INN or Proposed INN: Bosentan | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 24 | Italy | |||
| 30 | EUCTR2010-021825-11-IT (EUCTR) | 17/01/2011 | 08/02/2011 | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE-3 | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE-3 | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064908 MedDRA version: 9.1;Classification code 10064909 MedDRA version: 9.1;Classification code 10064910 | Trade Name: TRACLEER INN or Proposed INN: Bosentan | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy | |||
| 31 | JPRN-UMIN000004369 | 2011/01/01 | 01/01/2011 | Application of Exercise Echocardiography and Treatment by Bosentan in Latent Pulmonary Arterial Hypertension Associated with Connective Tissue Disease | Application of Exercise Echocardiography and Treatment by Bosentan in Latent Pulmonary Arterial Hypertension Associated with Connective Tissue Disease - Application of Exercise Echocardiography and Treatment by Bosentan in Latent Pulmonary Arterial Hypertension Associated with Connective Tissue Disease | Connective Tissue Disease | Bosentan | Tokushima University | NULL | Complete: follow-up complete | 18years-old | 85years-old | Male and Female | 20 | Not selected | Japan |
| 32 | EUCTR2010-021825-11-ES (EUCTR) | 22/12/2010 | 12/11/2010 | Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3 | Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3 | Hpertensión arterial pulmonar (PAH) en niños MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película INN or Proposed INN: BOSENTAN MONOHIDRATO Other descriptive name: BOSENTAN MONOHIDRATO | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 3 | Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy | ||
| 33 | EUCTR2010-021825-11-HU (EUCTR) | 08/12/2010 | 04/11/2010 | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy | |||
| 34 | EUCTR2010-021825-11-CZ (EUCTR) | 03/12/2010 | 03/12/2010 | A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China | |||
| 35 | EUCTR2010-021825-11-DE (EUCTR) | 26/11/2010 | 08/11/2010 | A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China | |||
| 36 | EUCTR2008-004533-21-NL (EUCTR) | 25/06/2010 | 14/11/2008 | The role of Bosentan in fontan patients: improvement of aerobic capacity - bosentan in fontan patients | The role of Bosentan in fontan patients: improvement of aerobic capacity - bosentan in fontan patients | To study whether bosentan (endothelin receptor inhibitor) improves aerobic capacity (VO2max) and exercise performance in adult patients with a Fontan operation. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: Tracleer Product Code: 66215-101 INN or Proposed INN: BOSENTAN Other descriptive name: Tracleer | ICIN | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Netherlands | |||
| 37 | EUCTR2005-005068-97-BE (EUCTR) | 29/10/2009 | 10/06/2009 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;Czech Republic;Greece;Spain;Belgium;Denmark;Germany;United Kingdom;Sweden | ||
| 38 | JPRN-JapicCTI-121998 | 01/9/2009 | 26/10/2012 | Bosentan PAH (WHO-FC II) | Open label multicenter study to assess the efficacy, safety, and tolerability of bosentan in Japanese patients with pulmonary arterial hypertension (PAH) in WHO functional class II. | Pulmonary arterial hypertension (PAH) | Intervention name : Ro47-0203 INN of the intervention : Bosentan Dosage And administration of the intervention : Oral administration, Initial dose: 62.5 mg b.i.d. for 4 weeks for all patients, Target dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg) | Actelion Pharmaceuticals Japan Ltd. | NULL | 18 | 74 | BOTH | 16 | Phase 3 | NULL | |
| 39 | EUCTR2005-005068-97-CZ (EUCTR) | 16/06/2009 | 11/06/2009 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 40 | NCT00864201 (ClinicalTrials.gov) | April 2009 | 17/3/2009 | A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease | A Pilot Study to Evaluate the Effect of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease | Hypertension, Pulmonary;Connective Tissue Disease | Drug: bosentan | Hamilton Health Sciences Corporation | Actelion | Not yet recruiting | 18 Years | N/A | Both | 10 | Phase 3 | Canada |
| 41 | NCT01100736 (ClinicalTrials.gov) | January 2009 | 30/3/2010 | Role of Endothelin-A (ETA) and Endothelin-B (ETB) Receptors in the Vasodilatory Response to Endothelin-3 (ET-3) | Characterisation of the Role of ETA and ETB Receptors in Regulating Plasma ET-1 and the Vasodilator Response to ET-3 in Man | Pulmonary Arterial Hypertension;Vasodilation;Vasoconstriction | Drug: Bosentan;Drug: Sitaxsentan;Drug: Placebo;Biological: Endothelin-3 | University of Edinburgh | Encysive Pharmaceuticals | Completed | 18 Years | 70 Years | Both | 10 | Phase 0 | United Kingdom |
| 42 | NCT00780728 (ClinicalTrials.gov) | December 2008 | 27/10/2008 | Study Evaluating the Addition of Sildenafil to Bosentan Therapy in Pulmonary Arterial Hypertension | Addition of Sildenafil to Bosentan Monotherapy in Patients With Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Sildenafil | University Health Network, Toronto | NULL | Withdrawn | 18 Years | N/A | Both | Phase 3 | Canada | |
| 43 | EUCTR2006-001464-23-GR (EUCTR) | 04/11/2008 | 30/01/2009 | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Revatio Product Name: Revatio® Product Code: UK-92,480 INN or Proposed INN: Sildenafil | Pfizer Ltd,Ramsgate Road,Sandwich CT13 9NJ | NULL | Not Recruiting | Female: yes Male: yes | 106 | Czech Republic;Greece;Germany;Italy;United Kingdom | |||
| 44 | EUCTR2005-005068-97-GR (EUCTR) | 23/09/2008 | 20/02/2009 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 4 | Portugal;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 45 | NCT00825266 (ClinicalTrials.gov) | September 2008 | 16/1/2009 | Insulin Resistance in Pulmonary Arterial Hypertension | The Effect of Bosentan and Pioglitazone on Insulin Resistance in Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: bosentan;Drug: Pioglitazone | Stanford University | NULL | Terminated | 18 Years | 75 Years | All | 2 | Phase 2 | United States |
| 46 | EUCTR2007-001643-21-GB (EUCTR) | 26/06/2008 | 10/10/2007 | Use of endothelin-1 antagonists in patients with Established Pulmonary Hypertension and Fibrotic Lung Disease. – A randomised, placebo-controlled, double-blinded study. - Tracleer in Interstitial Lung Disease and Pulmonary Hypertension | Use of endothelin-1 antagonists in patients with Established Pulmonary Hypertension and Fibrotic Lung Disease. – A randomised, placebo-controlled, double-blinded study. - Tracleer in Interstitial Lung Disease and Pulmonary Hypertension | Pulmonary hypertension in patients with interstitial lung disease. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: Tracleer INN or Proposed INN: Bosentan | Royal Brompton and Harefield NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 47 | EUCTR2005-005068-97-PT (EUCTR) | 06/06/2008 | 11/03/2008 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 48 | EUCTR2005-005068-97-ES (EUCTR) | 11/05/2008 | 03/03/2008 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2 | Hipertensión Arterial PulmonarPatients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 4 | Portugal;Czech Republic;Slovakia;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 49 | NCT00581607 (ClinicalTrials.gov) | April 2008 | 26/12/2007 | Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension | Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension | Sarcoidosis;Pulmonary Arterial Hypertension | Drug: Bosentan;Drug: Placebo | University of Cincinnati | Actelion | Completed | 18 Years | N/A | Both | 43 | Phase 2/Phase 3 | United States |
| 50 | EUCTR2005-005068-97-SK (EUCTR) | 06/03/2008 | 06/07/2010 | A clinical trial to investigate the safety and effectiveness of the combination of bosentan and sildenafil to treat patients with symptomatic pulmonary arterial hypertension in comparison to treatment with sildenafil on its own | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855 MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;United Kingdom;Czech Republic;Belgium;Brazil;Denmark;Germany;Sweden | ||
| 51 | NCT00909337 (ClinicalTrials.gov) | January 2008 | 27/5/2009 | Early Therapy of Pulmonary Arterial Hypertension | Early Therapy of Pulmonary Arterial Hypertension | Pulmonary Hypertension;Systemic Sclerosis | Drug: Bosentan | Medical University of Graz | Actelion | Completed | 18 Years | 90 Years | Both | 10 | N/A | Austria |
| 52 | EUCTR2005-005068-97-GB (EUCTR) | 30/10/2007 | 14/06/2007 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Portugal;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 53 | NCT00625469 (ClinicalTrials.gov) | October 2007 | 19/2/2008 | Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan | Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot Study | Pulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis | Drug: bosentan | Rajan Saggar | Actelion | Withdrawn | N/A | N/A | All | 0 | Phase 4 | United States |
| 54 | EUCTR2005-005068-97-DK (EUCTR) | 12/09/2007 | 11/05/2007 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 55 | EUCTR2005-005068-97-SE (EUCTR) | 18/06/2007 | 02/04/2007 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 56 | NCT00433329 (ClinicalTrials.gov) | March 2007 | 7/2/2007 | Combination Therapy in Pulmonary Arterial Hypertension | COMPASS 3: An Open-label, Multi-Center Study Employing a Targeted 6-Minute Walk Test (6-MWT) Distance Threshold Approach to Guide Bosentan-Based Therapy and to Assess the Utility of Magnetic Resonance Imaging (MRI) on Cardiac Remodeling | Pulmonary Arterial Hypertension | Drug: Bosentan;Drug: Sildenafil | Actelion | NULL | Completed | 12 Years | N/A | All | 100 | Phase 4 | United States |
| 57 | EUCTR2006-001464-23-IT (EUCTR) | 03/11/2006 | 19/02/2007 | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF ORAL SILDENAFIL 20MG TID OR PLACEBO WHEN ADDED TO BOSENTAN IN THE TREATMENT OF SUBJECTS, AGED 18 YEARS AND ABOVE, WITH PULMONARY ARTERIAL HYPERTENSION PAH - ND | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF ORAL SILDENAFIL 20MG TID OR PLACEBO WHEN ADDED TO BOSENTAN IN THE TREATMENT OF SUBJECTS, AGED 18 YEARS AND ABOVE, WITH PULMONARY ARTERIAL HYPERTENSION PAH - ND | Pulmonary Arterial Hypertension PAH . MedDRA version: 6.1;Level: PT;Classification code 10037400 | Trade Name: G04BE03- Sildenafil - sildenafil (citrato) Product Name: Sildenafil INN or Proposed INN: Sildenafil | PFIZER | NULL | Not Recruiting | Female: yes Male: yes | 106 | Czech Republic;Greece;Germany;United Kingdom;Italy | |||
| 58 | EUCTR2006-001464-23-GB (EUCTR) | 18/10/2006 | 11/06/2006 | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects, aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects, aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A | Pulmonary Arterial Hypertension MedDRA version: 8.0;Level: LLT;Classification code 10064911 | Product Name: Revatio® Product Code: UK-92,480 INN or Proposed INN: Sildenafil | Pfizer Ltd | NULL | Not Recruiting | Female: yes Male: yes | 106 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yes | Czech Republic;Greece;Germany;Italy;United Kingdom | ||
| 59 | EUCTR2004-000745-37-GB (EUCTR) | 10/10/2006 | 23/02/2005 | Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension | Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension | Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosis | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Spain;Italy;United Kingdom | |||
| 60 | NCT00323297 (ClinicalTrials.gov) | September 2006 | 5/5/2006 | Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension | A Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah) | Pulmonary Arterial Hypertension | Drug: Bosentan;Other: Placebo;Drug: Sildenafil Citrate | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | NULL | Completed | 18 Years | N/A | All | 105 | Phase 4 | United States;Australia;Czechia;France;Germany;Greece;Israel;Italy;Taiwan;United Kingdom;Belgium;Czech Republic |
| 61 | EUCTR2006-001464-23-DE (EUCTR) | 04/07/2006 | 05/05/2006 | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg three times daily or placebo when added to bosentan in the treatment of adult subjects, withpulmonary arterial hypertension. | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A | 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: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Trade Name: Revatio Product Name: Revatio® Product Code: UK-92,480 INN or Proposed INN: Sildenafil Other descriptive name: n/a | Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 106 | France;Czech Republic;Taiwan;Greece;Belgium;Australia;Israel;Germany;Italy;United Kingdom | |||
| 62 | EUCTR2005-005066-37-DE (EUCTR) | 09/06/2006 | 06/11/2006 | COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 | COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 | Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxinsPatients are already on prescribed bosentan therapy for at least 12 weeks. | Product Name: sildenafil Product Code: N/A INN or Proposed INN: Sildenafil citrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 2 | United Kingdom;Germany;Italy | ||
| 63 | EUCTR2006-001464-23-CZ (EUCTR) | 08/06/2006 | 21/04/2006 | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Revatio Product Name: Revatio® Product Code: UK-92,480 INN or Proposed INN: Sildenafil | Pfizer Ltd,Ramsgate Road,Sandwich CT13 9NJ | NULL | Not Recruiting | Female: yes Male: yes | 106 | Czech Republic;Greece;Germany;Italy;United Kingdom | |||
| 64 | NCT00595049 (ClinicalTrials.gov) | May 2006 | 7/1/2008 | Pulmonary Artery Remodelling With Bosentan | Open Label, Non Comparative Study to Investigate the Effect of Bosentan on Pulmonary Artery Remodelling in Pulmonary Arterial Hypertension (PAH). | Hypertension, Pulmonary | Drug: bosentan | Actelion | NULL | Completed | 18 Years | N/A | Both | 11 | Phase 4 | Australia;United States |
| 65 | NCT00303459 (ClinicalTrials.gov) | May 2006 | 16/3/2006 | Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH) | Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Prospective, Event Driven Phase IV Study | Pulmonary Arterial Hypertension | Drug: bosentan;Drug: placebo | Actelion | NULL | Completed | 12 Years | N/A | All | 334 | Phase 4 | United States;Brazil;Czech Republic;Denmark;Germany;Greece;Portugal;Saudi Arabia;Slovakia;Spain;Sweden;United Kingdom |
| 66 | EUCTR2005-005066-37-BE (EUCTR) | 21/04/2006 | 15/02/2006 | COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 | COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 | Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxinsPatients are already on prescribed bosentan therapy for at least 12 weeks. | Trade Name: viagra Product Name: sildenafil Product Code: N/A INN or Proposed INN: Sildenafil citrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 2 | Belgium;Germany;Italy;United Kingdom | ||
| 67 | NCT01721564 (ClinicalTrials.gov) | April 2006 | 1/11/2012 | Bosentan and Pulmonary Endothelial Function | Pulmonary Artery Remodelling With Bosentan | Pulmonary Arterial Hypertension | Drug: Bosentan | Prof David S Celermajer | NULL | Completed | 18 Years | 80 Years | All | 8 | N/A | NULL |
| 68 | EUCTR2005-005066-37-IT (EUCTR) | 21/03/2006 | 05/06/2006 | Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS 1 | Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS 1 | Patients suffering from pulmonary arterial hypertension PAH MedDRA version: 6.1;Level: PT;Classification code 10037400 | INN or Proposed INN: Sildenafil | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 2 | Germany;United Kingdom;Italy | ||
| 69 | EUCTR2005-005066-37-GB (EUCTR) | 15/03/2006 | 13/02/2006 | COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 | COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 | Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxins Patients are already on prescribed bosentan therapy for at least 12 weeks. | Trade Name: viagra Product Name: sildenafil Product Code: N/A INN or Proposed INN: Sildenafil citrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 44 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;Germany;Italy;United Kingdom | ||
| 70 | EUCTR2006-000021-57-DK (EUCTR) | 10/03/2006 | 24/02/2006 | Bosentan and Sildenfil for patients with Eisenmenger syndrome | Bosentan and Sildenfil for patients with Eisenmenger syndrome | Eisenmengers syndrome is condition with severe pulmonary arterial hypertension due to a shunting of blood from the left side of the heart to the right side of the heart. When the pressure in the pulmonary arteries levels the systemic blood pressure, blood begins to shunt from the right side of the heart to the left side of the heart leading to a condition with cyanosis, impaired physical capacity and increased mortality (Eisenmengers syndrome). | Trade Name: Tracleer Product Name: Tracleer Other descriptive name: Bosentan monohydrat Trade Name: VIAGRA Product Name: Viagra Other descriptive name: sildenafil | Rigshospitalet | NULL | Not Recruiting | Female: yes Male: yes | 20 | Denmark | |||
| 71 | NCT00310830 (ClinicalTrials.gov) | March 2006 | 3/4/2006 | Efficacy and Safety of Bosentan in Sickle Cell Disease (SCD) Patients With Pulmonary Arterial Hypertension (PAH) | Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Symptomatic Pulmonary Arterial Hypertension Associated With Sickle Cell Disease | Pulmonary Hypertension | Drug: Bosentan | Actelion | NULL | Terminated | 12 Years | N/A | Both | 14 | Phase 3 | United States;France;Netherlands;United Kingdom |
| 72 | NCT00303004 (ClinicalTrials.gov) | March 2006 | 14/3/2006 | Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome | Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome | Eisenmenger Syndrome | Drug: Bosentan and Sildenafil | Rigshospitalet, Denmark | NULL | Completed | 18 Years | N/A | Both | 20 | Phase 3 | Denmark |
| 73 | NCT00302211 (ClinicalTrials.gov) | February 1, 2006 | 10/3/2006 | The VISION Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension | A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients With Pulmonary Arterial Hypertension Receiving Oral Sildenafil | Pulmonary Hypertension | Drug: Inhaled Iloprost (5 µg);Drug: Inhaled Placebo;Drug: Sildenafil;Drug: Bosentan | Actelion | NULL | Terminated | 12 Years | 85 Years | All | 67 | Phase 3 | United States |
| 74 | EUCTR2004-004391-36-CZ (EUCTR) | 20/01/2006 | 05/01/2006 | A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension | A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension | Many endothelin receptor antagonists have profound effects on the histology and function of the testes in animals. These drugs have been shown to induce atrophy of the seminiferous tubules of the testes and to reduce sperm counts and male fertility in rats when administered for longer than 10 weeks. Where studied, testicular tubular atrophy and decreases in male fertility observed with endothelin receptor antagonists appear irreversible. | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: no Male: yes | 23 | Hungary;Czech Republic | |||
| 75 | EUCTR2005-001967-70-IT (EUCTR) | 20/10/2005 | 19/01/2007 | An open label long term safety and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 | An open label long term safety and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 | Treatment of pulmonary arterial hypertension in children MedDRA version: 14.1;Level: LLT;Classification code 10037405;Term: Pulmonary hypertension primary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: Bosentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 35 | Germany;United Kingdom;Italy | |||
| 76 | EUCTR2005-001967-70-GB (EUCTR) | 13/10/2005 | 25/08/2005 | An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2 | An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2 | Idiopathic or familial pulmonary arterial hypertension | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Germany;Italy;United Kingdom | ||
| 77 | NCT00319020 (ClinicalTrials.gov) | August 23, 2005 | 26/4/2006 | Bosentan in Children With Pulmonary Arterial Hypertension Extension Study | An Open Label, Long-term, Safety, and Tolerability Extension Study Using the Pediatric Formulation of Bosentan in the Treatment of Children With Idiopathic or Familial Pulmonary Arterial Hypertension Who Completed FUTURE 1 | Pulmonary Arterial Hypertension | Drug: Bosentan | Actelion | NULL | Completed | 2 Years | 11 Years | All | 33 | Phase 3 | United States;France;Germany;Italy;Netherlands;Switzerland;United Kingdom |
| 78 | NCT00593905 (ClinicalTrials.gov) | July 2005 | 3/1/2008 | Pharmacogenomics in Pulmonary Arterial Hypertension | Pharmacogenomics in Pulmonary Arterial Hypertension: A Multi-Center International Study to Determine Whether in PAH Patients Clinical Associations Exist Between the Efficacy and Toxicity of Endothelin Receptor Antagonists and Several Gene Polymorphisms in Several Key Disease-Specific and Therapy Specific Genes | Pulmonary Arterial Hypertension;Pulmonary Hypertension;PAH WHO Group I | Drug: Sitaxsentan;Drug: Bosentan, Ambrisentan | West Penn Allegheny Health System | National Institutes of Health (NIH);Baylor College of Medicine;Emory University;University of Chicago;Johns Hopkins University;Tufts Medical Center;Sir Mortimer B. Davis - Jewish General Hospital;London Health Sciences Centre;University of Maryland, College Park;University of California, San Francisco;University of Calgary;Chest Medical Associates;Columbia University;Lung Diagnostics, Ltd.;Duke University;University of California, Los Angeles;Latter Day Saints Hospital;Louisiana State University Health Sciences Center in New Orleans;Massachusetts General Hospital;Mayo Clinic;Medical College of Wisconsin;Southeastern Lung Care;Suncoast Lung Center;Children's Hospital Colorado;University Hospitals Cleveland Medical Center;University of Colorado, Denver;University of Michigan;University of Pittsburgh Medical Center;University of Southern California;The University of Texas Medical Branch, Galveston;Vanderbilt University;Wayne State University;Ohio State University;University of Alabama at Birmingham;Washington University School of Medicine;Sentara Norfolk General Hospital;University of Texas Southwestern Medical Center;Bay Area Chest Physicians | Withdrawn | N/A | N/A | All | 0 | United States | |
| 79 | EUCTR2004-005157-63-GB (EUCTR) | 15/06/2005 | 19/04/2005 | An open label, multicenter study to assess the pharmacokinetics, tolerability, and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension. - FUTURE 1 | An open label, multicenter study to assess the pharmacokinetics, tolerability, and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension. - FUTURE 1 | Idiopathic or familial PAH | Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 33 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy;United Kingdom | ||
| 80 | EUCTR2004-005157-63-IT (EUCTR) | 15/06/2005 | 15/02/2006 | An open label multicenter study to assess the pharmacokinetic, tolerability and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension iPAH | An open label multicenter study to assess the pharmacokinetic, tolerability and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension iPAH | Treatment of pulmonary arterial hypertension in children. MedDRA version: 6.1;Level: PT;Classification code 10037405 | Trade Name: TRACLEER 62,5MG 56CPR RIV. INN or Proposed INN: Bosentan | ACTELION PHARMACEUTICALS ITALIA | NULL | Not Recruiting | Female: yes Male: yes | 35 | United Kingdom;Italy | |||
| 81 | EUCTR2004-004391-36-HU (EUCTR) | 23/05/2005 | 23/02/2005 | A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension | A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension | Many endothelin receptor antagonists have profound effects on the histology and function of the testes in animals. These drugs have been shown to induce atrophy of the seminiferous tubules of the testes and to reduce sperm counts and male fertility in rats when administered for longer than 10 weeks. Where studied, testicular tubular atrophy and decreases in male fertility observed with endothelin receptor antagonists appear irreversible. | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: no Male: yes | 23 | Hungary;Czech Republic | |||
| 82 | NCT00319267 (ClinicalTrials.gov) | May 2005 | 26/4/2006 | Bosentan in Children With Pulmonary Arterial Hypertension | An Open Label, Multicenter Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Pediatric Formulation of Bosentan in Children With Idiopathic or Familial Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Bosentan | Actelion | NULL | Completed | 2 Years | 12 Years | Both | 36 | Phase 3 | United States;France;Germany;Italy;Netherlands;Switzerland;United Kingdom |
| 83 | EUCTR2004-000745-37-IT (EUCTR) | 15/03/2005 | 21/06/2005 | Uncontrolled extension trial to protocol AC-052-406 to evaluate the long term effect of bosentan therapy in patient with pulmonary arterial hypertension related to connective tissue disease (TRUST-extension) | Uncontrolled extension trial to protocol AC-052-406 to evaluate the long term effect of bosentan therapy in patient with pulmonary arterial hypertension related to connective tissue disease (TRUST-extension) | No modification of the label due to the fact that is an open label extension of a phase IV trial. MedDRA version: 6.1;Level: PT;Classification code 10037406 | Trade Name: TRACLEER*125MG 56CPR RIV. INN or Proposed INN: Bosentan | ACTELION PHARMACEUTICALS ITALIA | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom;Spain;Italy | ||||
| 84 | EUCTR2004-000478-30-ES (EUCTR) | 10/02/2005 | 03/11/2004 | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.There are no approved drug therapies for Class II PAH and the EARLY study is the first trial designed to enroll exclusively class II patients. | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | Czech Republic;Belgium;Spain;Denmark;Austria;Italy;United Kingdom;Sweden | ||
| 85 | EUCTR2004-000478-30-BE (EUCTR) | 14/12/2004 | 24/08/2005 | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Czech Republic;Spain;Belgium;Denmark;Austria;Italy;United Kingdom;Sweden | |||
| 86 | EUCTR2004-000478-30-AT (EUCTR) | 08/12/2004 | 03/11/2004 | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Czech Republic;Spain;Denmark;Austria;Italy;United Kingdom;Sweden | |||
| 87 | EUCTR2004-000478-30-CZ (EUCTR) | 26/11/2004 | 26/11/2004 | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden | |||
| 88 | EUCTR2004-000478-30-SE (EUCTR) | 28/10/2004 | 20/07/2004 | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden | |||
| 89 | EUCTR2004-000745-37-ES (EUCTR) | 11/10/2004 | 07/10/2004 | Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension | Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension | Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosis | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 4 | Spain;Italy;United Kingdom | ||
| 90 | EUCTR2004-000478-30-DK (EUCTR) | 10/09/2004 | 10/01/2007 | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 170 | United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden | |||
| 91 | EUCTR2004-000478-30-IT (EUCTR) | 09/09/2004 | 11/07/2007 | A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Treatment of pulmonary arterial hypertension (PAH) in patients with grade II modified NYHA MedDRA version: 14.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: TRACLEER*56CPR RIV 125MG INN or Proposed INN: Bosentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 170 | Czech Republic;Spain;Denmark;United Kingdom;Italy;Sweden | |||
| 92 | NCT00120380 (ClinicalTrials.gov) | September 2004 | 11/7/2005 | Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH) | Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension | Hypertension | Drug: Aerosolized iloprost;Drug: Placebo | Hannover Medical School | NULL | Terminated | 18 Years | 75 Years | Both | 40 | Phase 4 | Germany |
| 93 | NCT00266162 (ClinicalTrials.gov) | August 2004 | 15/12/2005 | Bosentan in Treatment of Pulmonary Arterial Hypertension | Therapy of Pulmonary Arterial Hypertension (PAH) With Bosentan in Patients With Eisenmenger Syndrome | Eisenmenger Syndrome | Drug: Bosentan administration | Competence Network for Congenital Heart Defects | German Federal Ministry of Education and Research;Actelion | Completed | 18 Years | N/A | Both | 60 | Phase 4 | Germany |
| 94 | EUCTR2004-000478-30-GB (EUCTR) | 15/07/2004 | 21/06/2005 | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. There are no approved drug therapies for Class II PAH and the EARLY study is the first trial designed to enroll exclusively class II patients. | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Other descriptive name: ------------ | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Belgium;Spain;Denmark;Austria;Italy;United Kingdom;Sweden | ||
| 95 | NCT00086463 (ClinicalTrials.gov) | June 2004 | 1/7/2004 | Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH) | A Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAH | Pulmonary Arterial Hypertension;Ayerza Syndrome;Pulmonary Hypertension | Drug: Iloprost or placebo | Actelion | NULL | Completed | 12 Years | 75 Years | Both | 60 | Phase 2 | United States |
| 96 | NCT00091715 (ClinicalTrials.gov) | April 2004 | 16/9/2004 | Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II | A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Mildly Symptomatic Pulmonary Arterial Hypertension (PAH) | Pulmonary Hypertension | Drug: bosentan;Drug: placebo | Actelion | NULL | Completed | 12 Years | N/A | Both | 185 | Phase 3 | United States;Australia;Austria;Belgium;Canada;China;Czech Republic;France;Germany;Italy;Netherlands;Spain;Switzerland;United Kingdom |
| 97 | NCT00367770 (ClinicalTrials.gov) | January 2004 | 21/8/2006 | BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology | A Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology | Pulmonary Arterial Hypertension | Drug: Tracleer® | Actelion | NULL | Completed | 12 Years | N/A | All | 37 | Phase 4 | United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom |
| 98 | NCT00317486 (ClinicalTrials.gov) | September 2003 | 21/4/2006 | Effects of Tracleer (Bosentan) on Pulmonary Arterial Hypertension Related to Eisenmenger Physiology | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Tracleer (Bosentan) on Oxygen Saturation and Cardiac Hemodynamics in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology | Pulmonary Arterial Hypertension Related to Eisenmenger Physiology | Drug: bosentan | Actelion | NULL | Completed | 12 Years | N/A | Both | 54 | Phase 4 | United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom |
| 99 | NCT00082186 (ClinicalTrials.gov) | July 2003 | 30/4/2004 | The Effect of Tracleer® on Male Fertility | TRACLEER® (Bosentan) Pulmonary Arterial Hypertension A Multicenter, Open-label, Single-arm Safety Study to Investigate the Effects of Chronic TRACLEER® Treatment on Testicular Function in Male Patients With Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: bosentan | Actelion | NULL | Completed | 18 Years | 65 Years | Male | 22 | Phase 4 | United States;Australia;Brazil;Czech Republic;Hungary |
| 100 | NCT00080457 (ClinicalTrials.gov) | May 2003 | 1/4/2004 | Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium (Thelin™) Treatment With an Open-Label Bosentan Arm in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Hypertension | Drug: sitaxsentan sodium | Encysive Pharmaceuticals | NULL | Completed | 12 Years | 75 Years | Both | 240 | Phase 3 | United States |
| 101 | EUCTR2011-004106-16-NL (EUCTR) | 10/02/2012 | A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound | A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | Actelion pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 105 | Phase 3 | Portugal;Serbia;United States;Philippines;Guatemala;Ukraine;Russian Federation;Chile;Colombia;India;Vietnam;France;Mexico;Argentina;Croatia;Peru;South Africa;Bulgaria;Netherlands;China | |||
| 102 | EUCTR2011-004612-31-NL (EUCTR) | 07/05/2012 | A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time. | A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | Actelion pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 105 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China | |||
| 103 | EUCTR2005-001967-70-DE (EUCTR) | 30/08/2005 | An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2 | An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2 | Idiopathic or familial pulmonary arterial hypertension | Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 30 | United Kingdom;Germany;Italy | ||||
| 104 | EUCTR2011-004106-16-FR (EUCTR) | 17/02/2012 | A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound | A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | Actelion pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 105 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China | |||
| 105 | EUCTR2011-004612-31-FR (EUCTR) | 27/08/2012 | A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time. | A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 15.0;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 15.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE | Actelion pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 105 | Phase 3 | Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China | |||
| 106 | EUCTR2010-021793-12-FR (EUCTR) | 04/02/2011 | A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | Pulmonary arterial hypertension (PAH) in children MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | NA | Female: yes Male: yes | 64 | Phase 3 | France;Czech Republic;Hungary;Poland;Spain;Netherlands;Germany;Italy | |||
| 107 | EUCTR2010-021825-11-FR (EUCTR) | 13/12/2010 | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | NA | Female: yes Male: yes | 64 | Phase 3 | France;Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy | |||
| 108 | EUCTR2005-005068-97-DE (EUCTR) | 13/02/2006 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Viagra INN or Proposed INN: sildenafil (as citrate) Trade Name: Viagra INN or Proposed INN: sildenafil (as citrate) Trade Name: Viagra INN or Proposed INN: sildenafil Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | |||
| 109 | EUCTR2010-021793-12-PL (EUCTR) | 25/07/2011 | A 1 year follow-up research project for children with pulmonary arterial hypertension (PAH) that participated in the FUTURE 3 core study. This is to find out how well bosentan is tolerated and safe when taken either two or three times a day | A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 3 | Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;South Africa;Netherlands;Germany;China |
88. 慢性血栓塞栓性肺高血圧症
臨床試験数 : 157 / 薬物数 : 107 - (DrugBank : 22) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 54
| 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 | EUCTR2005-002900-40-GB (EUCTR) | 28/04/2006 | 27/02/2006 | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocol AC-052-366/BENEFIT - BENEFIT-OL | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocol AC-052-366/BENEFIT - BENEFIT-OL | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Spain;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2005-002900-40-CZ (EUCTR) | 13/03/2006 | 13/03/2006 | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | United Kingdom;Germany;Czech Republic;Spain;Italy | |||
| 3 | EUCTR2005-002900-40-DE (EUCTR) | 03/03/2006 | 23/01/2006 | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 8.1;Level: LLT;Classification code 10037436;Term: Pulmonary thromboembolism | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: TRACLEER Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: TRACLEER | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Czech Republic;Spain;Germany;Italy;United Kingdom | |||
| 4 | EUCTR2005-002900-40-IT (EUCTR) | 23/01/2006 | 17/01/2007 | LONG-TERM OPEN-LABEL STUDY IN PATIENTS WITH INOPERABLE CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION CTEPH WHO COMPLETED THE PROTOCOL AC-052-366/BENEFIT. | LONG-TERM OPEN-LABEL STUDY IN PATIENTS WITH INOPERABLE CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION CTEPH WHO COMPLETED THE PROTOCOL AC-052-366/BENEFIT. | Treatment of inoperable chronic thronboembolic pulmonary hypertension. MedDRA version: 6.1;Level: PT;Classification code 10037400 | Trade Name: TRACLEER*56CPR RIV 125MG INN or Proposed INN: Bosentan | ACTELION PHARMACEUTICALS ITALIA | NULL | Not Recruiting | Female: yes Male: yes | 128 | Czech Republic;United Kingdom;Germany;Spain;Italy | |||
| 5 | EUCTR2005-002900-40-BE (EUCTR) | 18/01/2006 | 09/01/2006 | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Czech Republic;Spain;Belgium;Austria;Germany;Italy;United Kingdom | |||
| 6 | NCT00319111 (ClinicalTrials.gov) | January 2006 | 26/4/2006 | Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Long-term Open-label Extension Study in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Who Completed Protocol AC-052-366 (BENEFIT, NCT00313222) | Pulmonary Hypertension | Drug: bosentan | Actelion | NULL | Completed | 18 Years | 80 Years | All | 151 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom |
| 7 | EUCTR2005-001965-33-AT (EUCTR) | 15/12/2005 | 11/10/2005 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Spain;Austria;Germany;Italy;United Kingdom | |||
| 8 | EUCTR2005-001965-33-CZ (EUCTR) | 16/11/2005 | 12/10/2005 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 3 | Czech Republic;Spain;Austria;Germany;Italy;United Kingdom | ||
| 9 | EUCTR2005-001965-33-GB (EUCTR) | 04/11/2005 | 31/08/2005 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Spain;Austria;Germany;Italy;United Kingdom | ||
| 10 | EUCTR2005-001965-33-DE (EUCTR) | 01/11/2005 | 29/08/2005 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 8.1;Level: LLT;Classification code 10037436;Term: Pulmonary thromboembolism | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | United Kingdom;Germany;Spain;Italy | |||
| 11 | EUCTR2005-001965-33-IT (EUCTR) | 20/10/2005 | 25/01/2006 | PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF BOSENTAN IN PATIENTS WITH INOPERABLE CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION CTEPH . | PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF BOSENTAN IN PATIENTS WITH INOPERABLE CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION CTEPH . | Treatment of the inoperable chronic thromboembolic pulmonary hypertension MedDRA version: 6.1;Level: PT;Classification code 10037400 | Trade Name: TRACLEER 125MG 56CPR RIV. INN or Proposed INN: Bosentan | ACTELION PHARMACEUTICALS ITALIA | NULL | Not Recruiting | Female: yes Male: yes | 128 | United Kingdom;Germany;Spain;Italy | |||
| 12 | NCT00313222 (ClinicalTrials.gov) | October 2005 | 10/4/2006 | Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension | Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Chronic Thromboembolic Pulmonary Hypertension | Drug: bosentan | Actelion | NULL | Completed | 18 Years | 80 Years | Both | 157 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom |
| 13 | EUCTR2005-002900-40-AT (EUCTR) | 15/08/2005 | 07/11/2005 | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Czech Republic;Spain;Austria;Germany;Italy;United Kingdom |
210. 単心室症
臨床試験数 : 51 / 薬物数 : 53 - (DrugBank : 22) / 標的遺伝子数 : 32 - 標的パスウェイ数 : 67
| 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 | NCT01292551 (ClinicalTrials.gov) | February 2011 | 8/2/2011 | Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology. | Treatment With Endothelin Antagonist to Tcpc Patients; a Multicenter, Randomized, Prospective Study Measuring Maximal O2 Uptake in Ergometer Bicycle Test | Hypoplastic Left Heart Syndrome;Tricuspid Atresia;Other Specified Congenital Anomalies of Heart | Drug: Bosentan;Drug: Placebo | Rigshospitalet, Denmark | Aarhus University Hospital;Bispebjerg Hospital;Actelion | Completed | 15 Years | N/A | Both | 75 | Phase 2 | Denmark;Sweden |
| 2 | NCT00989911 (ClinicalTrials.gov) | May 2010 | 5/10/2009 | Endothelin Blockade in Patients With Single Ventricle Physiology | Endothelin Blockade in Patients With Single Ventricle Physiology | Congenital Heart Disease | Drug: Bosentan | University of California, Los Angeles | Actelion | Completed | 12 Years | N/A | All | 10 | N/A | United States |
| 3 | NCT01662037 (ClinicalTrials.gov) | January 2010 | 5/8/2012 | Bosentan Therapy in Children With Functional Single Ventricle | Bosentan Therapy for High Risk Staged Fontan Procedure in Children With Functional Single Ventricle | Congenital Heart Defects;Functional Single Ventricle | Drug: Bosentan | Shanghai Jiao Tong University School of Medicine | NULL | Completed | 4 Months | 18 Years | Both | 34 | Phase 2 | China |
| 4 | EUCTR2005-005898-29-GB (EUCTR) | 04/07/2008 | 09/05/2008 | The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation - Bosentan therapy in Fontans | The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation - Bosentan therapy in Fontans | Patients with a Fontan circulation (that is they have had a Fontan operation for a functionally univentricular heart) MedDRA version: 9.1;Level: LLT;Classification code 10045545;Term: Univentricular heart MedDRA version: 9.1;Classification code 10065950;Term: Cavopulmonary anastomosis MedDRA version: 9.1;Classification code 10037456;Term: Pulmonary vascular resistance abnormality | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: Bosentan INN or Proposed INN: Bosentan | University Hospital Birmingham | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom |
211. 左心低形成症候群
臨床試験数 : 22 / 薬物数 : 29 - (DrugBank : 9) / 標的遺伝子数 : 5 - 標的パスウェイ数 : 14
| 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 | NCT01292551 (ClinicalTrials.gov) | February 2011 | 8/2/2011 | Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology. | Treatment With Endothelin Antagonist to Tcpc Patients; a Multicenter, Randomized, Prospective Study Measuring Maximal O2 Uptake in Ergometer Bicycle Test | Hypoplastic Left Heart Syndrome;Tricuspid Atresia;Other Specified Congenital Anomalies of Heart | Drug: Bosentan;Drug: Placebo | Rigshospitalet, Denmark | Aarhus University Hospital;Bispebjerg Hospital;Actelion | Completed | 15 Years | N/A | Both | 75 | Phase 2 | Denmark;Sweden |
212. 三尖弁閉鎖症
臨床試験数 : 5 / 薬物数 : 6 - (DrugBank : 6) / 標的遺伝子数 : 8 - 標的パスウェイ数 : 12
| 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 | NCT01292551 (ClinicalTrials.gov) | February 2011 | 8/2/2011 | Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology. | Treatment With Endothelin Antagonist to Tcpc Patients; a Multicenter, Randomized, Prospective Study Measuring Maximal O2 Uptake in Ergometer Bicycle Test | Hypoplastic Left Heart Syndrome;Tricuspid Atresia;Other Specified Congenital Anomalies of Heart | Drug: Bosentan;Drug: Placebo | Rigshospitalet, Denmark | Aarhus University Hospital;Bispebjerg Hospital;Actelion | Completed | 15 Years | N/A | Both | 75 | Phase 2 | Denmark;Sweden |