Ambrisentan ( DrugBank: Ambrisentan )
7 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 51 | 全身性強皮症 | 8 |
| 84 | サルコイドーシス | 1 |
| 85 | 特発性間質性肺炎 | 17 |
| 86 | 肺動脈性肺高血圧症 | 62 |
| 88 | 慢性血栓塞栓性肺高血圧症 | 16 |
| 210 | 単心室症 | 2 |
| 211 | 左心低形成症候群 | 1 |
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 | EUCTR2014-001882-28-DE (EUCTR) | 13/10/2014 | 07/08/2014 | Drug treatment of patients with systemic sclerosis to prevent deterioration of pulmonary hypertension | Early Treatment of Borderline Pulmonary Arterial Hypertension Associated with Systemic Sclerosis (SSc-APAH) - EDITA | Systemic sclerosis-patients (SSc) with borderline pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Volibris Product Name: Ambrisentan | Thoraxklinik-Heidelberg gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 38 | Phase 2 | Germany | ||
| 2 | NCT02290613 (ClinicalTrials.gov) | July 1, 2014 | 31/10/2014 | Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) | Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) A Randomized, Controlled, Double-blind, Parallel Group, Proof-of-concept Trial EDITA | Systemic Sclerosis;Pulmonary Hypertension | Drug: Ambrisentan;Drug: Placebo | Heidelberg University | GlaxoSmithKline | Completed | 18 Years | N/A | All | 38 | Phase 2 | Germany |
| 3 | NCT02169752 (ClinicalTrials.gov) | September 2012 | 6/5/2014 | Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension | Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension | Pre-Pulmonary Atrial Hypertension | Drug: Ambrisentan | National Jewish Health | NULL | Terminated | 18 Years | 80 Years | All | 7 | N/A | United States |
| 4 | NCT01072669 (ClinicalTrials.gov) | February 2010 | 19/2/2010 | Efficacy of Ambrisentan in Limited Scleroderma Patients in Improving Blood Flow to Hands or Feet | Evaluation of the Effect of Ambrisentan on Digital Microvascular Flow in Patients With Systemic Sclerosis Using Laser Doppler Perfusion Imaging | Ischemia | Drug: ambrisentan | Soumya Chatterjee | Gilead Sciences | Completed | 18 Years | 70 Years | All | 20 | N/A | United States |
| 5 | NCT01093885 (ClinicalTrials.gov) | February 2010 | 24/3/2010 | Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis | An Open Label Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Treatment of Diffuse Systemic Sclerosis | Systemic Sclerosis;Scleroderma | Drug: Ambrisentan | University of Pennsylvania | Gilead Sciences | Completed | 19 Years | 90 Years | All | 15 | N/A | United States |
| 6 | NCT01042158 (ClinicalTrials.gov) | January 2010 | 4/1/2010 | A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis | A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis | Pulmonary Arterial Hypertension;Systemic Sclerosis;Scleroderma Spectrum of Diseases;Connective Tissue Disease;Pulmonary Hypertension | Drug: tadalafil and ambrisentan upfront combination therapy | Johns Hopkins University | National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);Eli Lilly and Company;United Therapeutics;The Cleveland Clinic;University of Texas;Stanford University | Completed | 18 Years | N/A | All | 25 | Phase 4 | United States |
| 7 | NCT01051960 (ClinicalTrials.gov) | March 2009 | 19/1/2010 | Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan | Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan: A Prospective Single Center, Open Label, Pilot Study | Systemic Sclerosis;Shortness of Breath;Pulmonary Hypertension | Drug: Ambrisentan | University of California, Los Angeles | Gilead Sciences | Completed | 18 Years | 80 Years | All | 12 | Phase 4 | United States |
| 8 | NCT00725361 (ClinicalTrials.gov) | June 2008 | 28/7/2008 | A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma). | A Pilot Study to Evaluate the Efficacy of Ambrisentan in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis. | n Ulcer;Scleroderma, Systemic | Drug: Ambrisentan | Stanford University | NULL | Completed | 18 Years | N/A | All | 20 | N/A | United States |
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 | NCT00851929 (ClinicalTrials.gov) | November 2008 | 24/2/2009 | Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension | Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary Hypertension | Sarcoidosis;Pulmonary Hypertension | Drug: Ambrisentan | Medical University of South Carolina | Gilead Sciences | Completed | 18 Years | 99 Years | All | 16 | Phase 2/Phase 3 | United States |
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 | EUCTR2009-011169-98-CZ (EUCTR) | 10/01/2011 | 29/11/2010 | ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH | ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH | Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis MedDRA version: 12.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis MedDRA version: 12.1;Classification code 10037400;Term: Pulmonary hypertension | Trade Name: Letairis INN or Proposed INN: Ambrisentan Trade Name: Letairis INN or Proposed INN: Ambrisentan | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | United Kingdom;Germany;Czech Republic;Italy;Austria | ||
| 2 | EUCTR2008-004405-34-CZ (EUCTR) | 13/09/2010 | 07/01/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 3 | EUCTR2009-011169-98-AT (EUCTR) | 26/11/2009 | 25/08/2009 | ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH | ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH | Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis MedDRA version: 12.0;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis MedDRA version: 12.0;Classification code 10037400;Term: Pulmonary hypertension | Trade Name: Letairis INN or Proposed INN: Ambrisentan Trade Name: Letairis INN or Proposed INN: Ambrisentan | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | Czech Republic;United Kingdom;Germany;Italy;Austria | ||
| 4 | EUCTR2009-011169-98-DE (EUCTR) | 03/11/2009 | 06/08/2009 | ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH | ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH | Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis MedDRA version: 12.0;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis MedDRA version: 12.0;Classification code 10037400;Term: Pulmonary hypertension | Trade Name: Letairis INN or Proposed INN: Ambrisentan Trade Name: Letairis INN or Proposed INN: Ambrisentan | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | Czech Republic;United Kingdom;Germany;Italy;Austria | ||
| 5 | EUCTR2009-011169-98-GB (EUCTR) | 30/10/2009 | 01/09/2009 | ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH | ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ARTEMIS-PH | Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis MedDRA version: 12.0;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis MedDRA version: 12.0;Classification code 10037400;Term: Pulmonary hypertension | Trade Name: Letairis INN or Proposed INN: Ambrisentan Trade Name: Letairis INN or Proposed INN: Ambrisentan | Gilead Sciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | Czech Republic;Germany;United Kingdom;Italy;Austria | ||
| 6 | EUCTR2009-011169-98-IT (EUCTR) | 22/09/2009 | 21/09/2009 | A Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ND | A Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - ND | Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10021240 MedDRA version: 9.1;Classification code 10037400 | Trade Name: Letairis Trade Name: Letairis | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | Czech Republic;United Kingdom;Germany;Italy;Austria | ||
| 7 | EUCTR2008-004405-34-IE (EUCTR) | 08/09/2009 | 07/01/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 8 | EUCTR2008-004405-34-IT (EUCTR) | 03/08/2009 | 27/07/2009 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | Idiopathic pulmonary fibrosis MedDRA version: 12.0;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: VOLIBRIS INN or Proposed INN: Ambrisentan Trade Name: VOLIBRIS INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 9 | NCT00879229 (ClinicalTrials.gov) | July 2009 | 8/4/2009 | ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension | Idiopathic Pulmonary Fibrosis;Pulmonary Hypertension | Drug: Ambrisentan;Drug: Placebo | Gilead Sciences | NULL | Terminated | 35 Years | 80 Years | All | 40 | Phase 3 | United States;Australia;Austria;Canada;Germany;Italy;United Kingdom;Belgium;Ireland;Israel |
| 10 | EUCTR2008-004405-34-GB (EUCTR) | 08/06/2009 | 28/04/2009 | ARTEMIS-IPF: A Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | ARTEMIS-IPF: A Phase 3, Randomized, Double Blind, Placebo Controlled, Multi Center, Parallel Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 11 | EUCTR2008-004405-34-NL (EUCTR) | 04/06/2009 | 10/03/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | France;Czech Republic;Spain;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 12 | EUCTR2008-004405-34-ES (EUCTR) | 27/03/2009 | 28/01/2009 | ARTEMIS: A Phase 3, Randomized, Double-Blind,Placebo-Controlled, Multi-Center, Parallel-Group,Event-Driven Study to Evaluate the Efficacy and Safety ofAmbrisentan in Subjects with Early Idiopathic PulmonaryFibrosis (IPF)ARTEMIS: Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo, multicéntrico, con grupos paralelos, en función de eventos, para evaluar la eficacia y seguridad de ambrisentan en sujetos con fibrosis pulmonar idiopática temprana (FPI). - ARTEMIS | ARTEMIS: A Phase 3, Randomized, Double-Blind,Placebo-Controlled, Multi-Center, Parallel-Group,Event-Driven Study to Evaluate the Efficacy and Safety ofAmbrisentan in Subjects with Early Idiopathic PulmonaryFibrosis (IPF)ARTEMIS: Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo, multicéntrico, con grupos paralelos, en función de eventos, para evaluar la eficacia y seguridad de ambrisentan en sujetos con fibrosis pulmonar idiopática temprana (FPI). - ARTEMIS | Idiopathic Pulmonary Fibrosis (IPF)fibrosis pulmonar idiopática temprana (FPI) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 13 | EUCTR2008-004405-34-AT (EUCTR) | 13/03/2009 | 21/01/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 14 | EUCTR2008-004405-34-BE (EUCTR) | 09/03/2009 | 22/01/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 15 | EUCTR2008-004405-34-FR (EUCTR) | 09/02/2009 | 16/03/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Czech Republic;Spain;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 16 | NCT00768300 (ClinicalTrials.gov) | December 2008 | 7/10/2008 | (ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF | ARTEMIS-IPF: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Early Idiopathic Pulmonary Fibrosis (IPF) | Idiopathic Pulmonary Fibrosis | Drug: Ambrisentan;Drug: Placebo | Gilead Sciences | NULL | Terminated | 40 Years | 80 Years | All | 494 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czech Republic;France;Germany;Ireland;Israel;Italy;Mexico;Netherlands;Peru;Poland;Spain;Switzerland;United Kingdom |
| 17 | EUCTR2008-004405-34-DE (EUCTR) | 14/01/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF) - ARTEMIS-IPF | Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Trade Name: Letairis 5 mg INN or Proposed INN: Ambrisentan Trade Name: Letairis 10 mg INN or Proposed INN: Ambrisentan | Gilead Sciences Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 660 | Phase 3 | France;Czech Republic;Spain;Belgium;Ireland;Austria;Netherlands;Germany;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 | NCT04972656 (ClinicalTrials.gov) | September 5, 2022 | 9/7/2021 | Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension | Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension: a Multicenter, Randomized, Double-blind, Placebo-controlled Study | Pulmonary Arterial Hypertension | Drug: Ambrisentan;Drug: Placebo | Nanjing First Hospital, Nanjing Medical University | Tianjin Medical University General Hospital | Recruiting | 18 Years | N/A | All | 420 | N/A | China |
| 2 | NCT04528056 (ClinicalTrials.gov) | August 1, 2020 | 14/8/2020 | Pilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial Hypertension | Pilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Sulfasalazine;Drug: Ambrisentan;Drug: Sulfasalazine's placebo;Drug: Ambrisentan's placebo | RenJi Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 80 | Phase 1/Phase 2 | China |
| 3 | EUCTR2019-001699-12-GB (EUCTR) | 27/08/2019 | 30/07/2019 | Relative bioavailability study of marketed and lower dose ambrisentan in healthy adult participants | An open-label, randomized three period cross-over relative bioavailability study to compare the pharmacokinetic parameters of a lower dose formulation of ambrisentan (GSK1325760) with marketed ambrisentan in healthy adult participants | Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ambrisentan Tablet Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: (S)-2-(4,6-dimethylpyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropanoic acid Trade Name: Volibris Product Name: Ambrisentan 5mg film-coated tablets [marketed product] INN or Proposed INN: AMBRISENTAN Other descriptive name: (S)-2-(4,6-dimethylpyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropanoic acid | GlaxoSmithKline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 1 | United Kingdom | ||
| 4 | NCT02999906 (ClinicalTrials.gov) | October 2017 | 19/12/2016 | Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Oral Treprostinil;Drug: Placebo | United Therapeutics | NULL | Withdrawn | 18 Years | 79 Years | All | 0 | Phase 3 | NULL |
| 5 | 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 |
| 6 | NCT03809156 (ClinicalTrials.gov) | April 26, 2016 | 9/1/2019 | Upfront Combination Pulmonary Arterial Hypertension Therapy | Upfront Riociguat and Ambrisentan Combination Therapy for Pulmonary Arterial Hypertension: A Safety and Efficacy Pilot Study | Pulmonary Hypertension | Drug: Riociguat Oral Product | University of Calgary | Bayer | Recruiting | 18 Years | N/A | All | 20 | Phase 4 | Canada |
| 7 | NCT02253394 (ClinicalTrials.gov) | September 2015 | 17/9/2014 | The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study | The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (The CAPS-PAH Study) | Pulmonary Arterial Hypertension | Drug: Ambrisentan plus Spironolactone;Drug: Ambrisentan plus Placebo | Brigham and Women's Hospital | Gilead Sciences | Terminated | 18 Years | N/A | All | 2 | Phase 4 | United States |
| 8 | 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 | |||
| 9 | EUCTR2014-001882-28-DE (EUCTR) | 13/10/2014 | 07/08/2014 | Drug treatment of patients with systemic sclerosis to prevent deterioration of pulmonary hypertension | Early Treatment of Borderline Pulmonary Arterial Hypertension Associated with Systemic Sclerosis (SSc-APAH) - EDITA | Systemic sclerosis-patients (SSc) with borderline pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Volibris Product Name: Ambrisentan | Thoraxklinik-Heidelberg gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 38 | Phase 2 | Germany | ||
| 10 | NCT02290613 (ClinicalTrials.gov) | July 1, 2014 | 31/10/2014 | Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) | Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) A Randomized, Controlled, Double-blind, Parallel Group, Proof-of-concept Trial EDITA | Systemic Sclerosis;Pulmonary Hypertension | Drug: Ambrisentan;Drug: Placebo | Heidelberg University | GlaxoSmithKline | Completed | 18 Years | N/A | All | 38 | Phase 2 | Germany |
| 11 | NCT01808313 (ClinicalTrials.gov) | December 1, 2012 | 28/2/2013 | Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH) | An Open Label Phase IIIb Study to Evaluate Efficacy and Safety of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH) | Vascular Disease | Drug: ambrisentan | GlaxoSmithKline | NULL | Completed | 18 Years | 75 Years | All | 134 | Phase 3 | China |
| 12 | NCT02169752 (ClinicalTrials.gov) | September 2012 | 6/5/2014 | Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension | Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension | Pre-Pulmonary Atrial Hypertension | Drug: Ambrisentan | National Jewish Health | NULL | Terminated | 18 Years | 80 Years | All | 7 | N/A | United States |
| 13 | EUCTR2010-021572-29-IT (EUCTR) | 19/09/2011 | 07/02/2011 | An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired - AMB114588 | An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired - AMB114588 | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064908 MedDRA version: 9.1;Classification code 10064910 MedDRA version: 9.1;Classification code 10064909 | Trade Name: VOLIBRIS INN or Proposed INN: ambrisentan Trade Name: VOLIBRIS INN or Proposed INN: ambrisentan INN or Proposed INN: Ambrisentan | GlaxoSmithKline Research & Development, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | Hungary;Greece;Spain;Netherlands;Germany;Italy | |||
| 14 | EUCTR2010-021572-29-NL (EUCTR) | 19/07/2011 | 11/11/2010 | An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired | An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired | Pulmonary Arterial Hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension | Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN INN or Proposed INN: AMBRISENTAN Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan Product Name: ambrisentan Product Code: GSK1325760 | GlaxoSmithKline Research & Development, Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 66 | Hungary;Germany;Netherlands;Spain;Italy;Greece | |||
| 15 | NCT01342952 (ClinicalTrials.gov) | June 21, 2011 | 26/4/2011 | Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529 | An Open-label, Long Term Extension Study for Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years Who Have Participated in AMB112529 and in Whom Continued Treatment With Ambrisentan is Desired | Hypertension, Pulmonary | Drug: Ambrisentan | GlaxoSmithKline | NULL | Completed | 8 Years | 18 Years | All | 38 | Phase 2 | United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Mexico;Netherlands |
| 16 | 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 |
| 17 | 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 |
| 18 | EUCTR2010-021572-29-ES (EUCTR) | 19/01/2011 | 17/11/2010 | Estudio de extensión abierto y a largo plazo sobre el tratamiento de la hipertensión arterial pulmonar en pacientes pediátricos de 8 a 18 años de edad que han participado en el estudio AMB112529 y para los que se desea tratamiento continuo con ambrisentan.An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired. | Estudio de extensión abierto y a largo plazo sobre el tratamiento de la hipertensión arterial pulmonar en pacientes pediátricos de 8 a 18 años de edad que han participado en el estudio AMB112529 y para los que se desea tratamiento continuo con ambrisentan.An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired. | Hipertensión Arterial PulmonarPulmonary Arterial Hypertension MedDRA version: 13;Level: LLT;Classification code 10064911;Term: Hipertensión arterial pulmonar MedDRA version: 13;Classification code 10065150;Term: Hipertensión pulmonar arterial primaria asociada MedDRA version: 13;Classification code 10065151;Term: Hipertensión pulmonar arterial primaria idiopática MedDRA version: 13;Classification code 10065152;Term: Hipertensión pulmonar arterial primaria familiar MedDRA version: 13;Level: PT;Term: Hipertensión arterial pulmonar | Trade Name: VOLIBRIS 10 mg comprimidos recubiertos con película INN or Proposed INN: AMBRISENTAN Other descriptive name: AMBRISENTAN Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película INN or Proposed INN: AMBRISENTAN Other descriptive name: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan | GlaxoSmithKline, S.A | NULL | Not Recruiting | Female: yes Male: yes | 66 | Hungary;Greece;Spain;Netherlands;Germany;Italy | |||
| 19 | EUCTR2010-021572-29-DE (EUCTR) | 11/01/2011 | 10/11/2010 | An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired | An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired | Pulmonary Arterial Hypertension MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 16.0;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN | GlaxoSmithKline Research & Development, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 3 | France;Hungary;Greece;Spain;Netherlands;Germany;Italy | ||
| 20 | EUCTR2010-021572-29-HU (EUCTR) | 10/01/2011 | 22/11/2010 | An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired | An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired | Pulmonary Arterial Hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension | Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN INN or Proposed INN: AMBRISENTAN Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan Product Name: ambrisentan Product Code: GSK1325760 | GlaxoSmithKline Research & Development, Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 66 | Hungary;Germany;Netherlands;Spain;Italy;Greece | |||
| 21 | NCT01332331 (ClinicalTrials.gov) | January 4, 2011 | 24/3/2011 | Efficacy and Safety of Ambrisentan in Children 8-18yrs | A Randomized, Open Label Study Comparing Safety and Efficacy Parameters for a High and a Low Dose of Ambrisentan (Adjusted for Body Weight) for the Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years | Hypertension, Pulmonary | Drug: Ambrisentan - low dose;Drug: Ambrisentan - high dose | GlaxoSmithKline | NULL | Terminated | 8 Years | 18 Years | All | 41 | Phase 2 | United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Greece;Mexico;Netherlands |
| 22 | NCT01406327 (ClinicalTrials.gov) | December 14, 2010 | 28/7/2011 | Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension) | Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension) | Hypertension, Pulmonary | Drug: Ambrisentan | GlaxoSmithKline | NULL | Completed | N/A | N/A | All | 900 | NULL | |
| 23 | EUCTR2010-019547-19-IT (EUCTR) | 30/11/2010 | 14/12/2010 | A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years - AMB112529 | A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years - AMB112529 | pulmonary arterial hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911 MedDRA version: 9.1;Classification code 10065150 MedDRA version: 9.1;Classification code 10065151 MedDRA version: 9.1;Classification code 10065152 | Trade Name: VOLIBRIS INN or Proposed INN: AMBRISENTAN Trade Name: VOLIBRIS INN or Proposed INN: AMBRISENTAN Product Name: AMBRISENTAN Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN | GlaxoSmithKline Research & Development, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | France;Hungary;Greece;Spain;Germany;Netherlands;Italy | |||
| 24 | EUCTR2010-021572-29-GR (EUCTR) | 23/11/2010 | 26/10/2010 | An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired | An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired | Pulmonary Arterial Hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension | Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan | GlaxoSmithKline Research & Development, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | Hungary;Germany;Netherlands;Spain;Italy;Greece | |||
| 25 | EUCTR2009-011150-17-BE (EUCTR) | 15/11/2010 | 14/06/2010 | Study of two drugs used to treat pulmonary arterial hypertension (PAH) | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Pulmonary arterial hypotension MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 614 | United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden | |||
| 26 | EUCTR2010-019547-19-FR (EUCTR) | 12/11/2010 | 23/08/2010 | A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. | A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. | Pulmonary Arterial Hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension | Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN | GlaxoSmithKline Research & Development, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Greece;Spain;Germany;Netherlands;Italy | ||
| 27 | EUCTR2010-019547-19-NL (EUCTR) | 05/11/2010 | 01/07/2010 | A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. | A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. | Pulmonary Arterial Hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension | Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan | GlaxoSmithKline Research & Development, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | France;Hungary;Greece;Spain;Germany;Netherlands;Italy | ||
| 28 | EUCTR2010-019547-19-HU (EUCTR) | 15/10/2010 | 12/07/2010 | A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. | A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. | Pulmonary Arterial Hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension | Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan Product Name: ambrisentan Product Code: GSK1325760 | GlaxoSmithKline Research & Development, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | France;Hungary;Greece;Spain;Germany;Netherlands;Italy | ||
| 29 | EUCTR2010-019547-19-ES (EUCTR) | 06/10/2010 | 15/07/2010 | Estudio abierto, aleatorizado, para comparar parámetros de seguridad y eficacia para una dosis alta y una baja de ambrisentan (ajustadas al peso corporal), como tratamiento para la hipertensión arterial pulmonar en pacientes pediátricos entre 8 y 18 años. A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. | Estudio abierto, aleatorizado, para comparar parámetros de seguridad y eficacia para una dosis alta y una baja de ambrisentan (ajustadas al peso corporal), como tratamiento para la hipertensión arterial pulmonar en pacientes pediátricos entre 8 y 18 años. A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. | Hipertensión arterial pulmonar MedDRA version: 13;Level: LLT;Classification code 10064911;Term: Hipertensión arterial pulmonar MedDRA version: 13;Level: PT;Classification code 10065150;Term: Hipertensión pulmonar arterial primaria asociada MedDRA version: 13;Classification code 10065151;Term: Hipertensión pulmonar arterial primaria idiopática MedDRA version: 13;Classification code 10065152;Term: Hipertensión pulmonar arterial primaria familiar | Trade Name: VOLIBRIS 10 mg comprimidos recubiertos con película INN or Proposed INN: AMBRISENTAN Other descriptive name: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película INN or Proposed INN: AMBRISENTAN Other descriptive name: AMBRISENTAN | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 66 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Greece;Spain;Germany;Netherlands;Italy | ||
| 30 | EUCTR2010-019547-19-DE (EUCTR) | 05/10/2010 | 14/07/2010 | A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. | A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. | 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 MedDRA version: 14.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN | GlaxoSmithKline Research & Development, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | France;Hungary;Greece;Spain;Netherlands;Germany;Italy | ||
| 31 | NCT01178073 (ClinicalTrials.gov) | October 1, 2010 | 15/7/2010 | A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: ambrisentan;Drug: tadalafil | GlaxoSmithKline | Gilead Sciences | Completed | 18 Years | 75 Years | All | 610 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Greece;Italy;Japan;Netherlands;Spain;Sweden;United Kingdom |
| 32 | EUCTR2009-011150-17-FR (EUCTR) | 24/09/2010 | 13/08/2010 | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Pulmonary arterial hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension | Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 352 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 33 | EUCTR2009-011150-17-NL (EUCTR) | 26/08/2010 | 26/05/2010 | Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Pulmonary arterial hypotension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Virus Diseases [C02] | Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 545 | Phase 4 | France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden | ||
| 34 | EUCTR2009-011150-17-DE (EUCTR) | 16/08/2010 | 03/08/2010 | Study of two drugs used to treat pulmonary arterial hypertension (PAH) | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Pulmonary arterial hypotension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 614 | United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Sweden | |||
| 35 | EUCTR2009-011150-17-GB (EUCTR) | 11/08/2010 | 22/06/2010 | Study of two drugs used to treat pulmonary arterial hypertension (PAH) | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Pulmonary arterial hypotension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 545 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 36 | EUCTR2009-011150-17-IT (EUCTR) | 06/08/2010 | 09/08/2010 | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Pulmonary arterial hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911 | Trade Name: VOLIBRIS Trade Name: CIALIS INN or Proposed INN: Tadalafil | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 352 | France;Greece;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden | |||
| 37 | EUCTR2009-011150-17-AT (EUCTR) | 03/08/2010 | 22/06/2010 | Study of two drugs used to treat pulmonary arterial hypertension (PAH) | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Pulmonary arterial hypotension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 545 | United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden | |||
| 38 | EUCTR2009-011150-17-GR (EUCTR) | 16/07/2010 | 14/07/2010 | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Pulmonary arterial hypotension MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 352 | France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 39 | EUCTR2010-019547-19-GR (EUCTR) | 16/07/2010 | 30/06/2010 | A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. | A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. | Pulmonary Arterial Hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension | Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: ambrisentan | GlaxoSmithKline Research & Development, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | Hungary;Germany;Netherlands;France;Spain;Italy;Greece | |||
| 40 | EUCTR2009-011150-17-SE (EUCTR) | 14/07/2010 | 18/06/2010 | Study of two drugs used to treat pulmonary arterial hypertension (PAH) | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Pulmonary arterial hypotension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets INN or Proposed INN: AMBRISENTAN Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 545 | United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden | |||
| 41 | EUCTR2009-011150-17-ES (EUCTR) | 13/07/2010 | 02/06/2010 | AMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | AMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Hipertensión arterial pulmonar MedDRA version: 11;Level: PT;Classification code 10064911;Term: Hipertensión arterial pulmonar MedDRA version: 11;Level: LLT;Term: Hipertensión arterial pulmonar | Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película INN or Proposed INN: AMBRISENTAN Other descriptive name: AMBRISENTAN Trade Name: CIALIS 20 mg comprimidos recubiertos con película INN or Proposed INN: TADALAFILO Other descriptive name: TADALAFIL | GlaxoSmithKline,S.A. | NULL | Not Recruiting | Female: yes Male: yes | 352 | France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 42 | NCT01042158 (ClinicalTrials.gov) | January 2010 | 4/1/2010 | A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis | A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis | Pulmonary Arterial Hypertension;Systemic Sclerosis;Scleroderma Spectrum of Diseases;Connective Tissue Disease;Pulmonary Hypertension | Drug: tadalafil and ambrisentan upfront combination therapy | Johns Hopkins University | National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);Eli Lilly and Company;United Therapeutics;The Cleveland Clinic;University of Texas;Stanford University | Completed | 18 Years | N/A | All | 25 | Phase 4 | United States |
| 43 | NCT01338636 (ClinicalTrials.gov) | September 2008 | 18/4/2011 | An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Participants With Exercise-Induced Pulmonary Arterial Hypertension (PAH) | An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Patients With Exercise Induced Pulmonary Arterial Hypertension | Exercise-induced Pulmonary Arterial Hypertension | Drug: Ambrisentan | Brigham and Women's Hospital | Gilead Sciences | Completed | 18 Years | N/A | All | 30 | Phase 4 | United States |
| 44 | NCT00617305 (ClinicalTrials.gov) | April 2008 | 6/2/2008 | Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1) | An Open-label, Multicenter Study of Ambrisentan and a Phosphodiesterase Type-5 Inhibitor Combination Therapy in Subjects With Pulmonary Arterial Hypertension Who Have Demonstrated a Sub-Optimal Response to a Phosphodiesterase Type-5 Inhibitor | Pulmonary Arterial Hypertension | Drug: Ambrisentan;Drug: Placebo;Drug: Sildenafil;Drug: Tadalafil | Gilead Sciences | NULL | Completed | 16 Years | 75 Years | All | 38 | Phase 4 | United States |
| 45 | EUCTR2005-000812-29-IT (EUCTR) | 15/11/2005 | 15/02/2006 | ARIES-1 - Ambrisentan in PAH A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension | ARIES-1 - Ambrisentan in PAH A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension | PULMONARY ARTERIAL HYPERTENSION MedDRA version: 6.1;Level: PT;Classification code 10037400 | Product Name: Ambrisentan | MYOGEN INC. | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | Hungary;Germany;Belgium;Spain;Italy | ||
| 46 | EUCTR2005-001193-28-AT (EUCTR) | 08/11/2005 | 04/10/2005 | ARIES-320/321-E A Long-Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 or AMB-321 - 320/321-E | ARIES-320/321-E A Long-Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 or AMB-321 - 320/321-E | Pulmonary Arterial Hypertension | Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan | Myogen, Inc | NULL | Not Recruiting | Female: yes Male: yes | 372 | Austria | |||
| 47 | EUCTR2005-000812-29-AT (EUCTR) | 08/11/2005 | 04/10/2005 | ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1 | ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1 | Pulmonary Arterial Hypertension | Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan | Myogen, Inc | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | Hungary;Belgium;Spain;Austria;Germany;Italy | ||
| 48 | EUCTR2005-000812-29-DE (EUCTR) | 07/11/2005 | 02/03/2007 | ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1 | ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1 | Pulmonary Arterial Hypertension | Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan | Myogen, Inc | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | Hungary;Germany;Belgium;Spain;Italy | ||
| 49 | EUCTR2005-000812-29-ES (EUCTR) | 21/10/2005 | 19/09/2005 | ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1 | ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1 | Pulmonary Arterial Hypertension | Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan | Myogen, Inc | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | Hungary;Belgium;Spain;Austria;Germany;Italy | ||
| 50 | EUCTR2005-001564-31-DE (EUCTR) | 07/10/2005 | 08/07/2005 | A phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects with Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase Abnormalities - NA | A phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects with Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase Abnormalities - NA | Pulmonary Arterial Hypertension MedDRA version: 7.0;Level: low;Classification code 10037400 | Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan | Myogen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Belgium;Germany | ||
| 51 | EUCTR2005-000812-29-HU (EUCTR) | 21/09/2005 | 11/08/2005 | Ambrisentan in PAH - A Phase III, Randomised, Double- Blind, Placebo- Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension - ARIES-1 | Ambrisentan in PAH - A Phase III, Randomised, Double- Blind, Placebo- Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension - ARIES-1 | Pulmonary Arterial Hypertension MedDRA version: 7.0;Level: low;Classification code 10037400 | Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan | Myogen, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | Hungary;Belgium;Spain;Austria;Germany;Italy | ||
| 52 | EUCTR2005-000812-29-BE (EUCTR) | 16/09/2005 | 08/02/2006 | ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1 | ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1 | Pulmonary Arterial Hypertension | Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan Product Name: Ambrisentan Product Code: BSF 208075 INN or Proposed INN: Ambrisentan | Myogen, Inc | NULL | Not Recruiting | Female: yes Male: yes | 186 | Phase 3 | Hungary;Germany;Belgium;Spain;Italy | ||
| 53 | EUCTR2005-001564-31-BE (EUCTR) | 16/08/2005 | 15/12/2005 | A phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects with Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase Abnormalities - NA | A phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects with Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase Abnormalities - NA | Pulmonary Arterial Hypertension MedDRA version: 7.0;Level: low;Classification code 10037400 | Product Name: Ambrisentan Product Code: BSF 208075 or LU 208075 INN or Proposed INN: Ambrisentan INN or Proposed INN: Ambrisentan INN or Proposed INN: Ambrisentan | Myogen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Belgium;Germany | ||
| 54 | 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 | |
| 55 | NCT00423592 (ClinicalTrials.gov) | May 2005 | 17/1/2007 | Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension | A Phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects With Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase Abnormalities | Pulmonary Hypertension | Drug: ambrisentan | Gilead Sciences | NULL | Completed | 12 Years | 75 Years | All | 36 | Phase 2 | NULL |
| 56 | NCT00578786 (ClinicalTrials.gov) | February 2004 | 19/12/2007 | A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202) | A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202) | Pulmonary Arterial Hypertension | Drug: ambrisentan | Gilead Sciences | NULL | Completed | 18 Years | N/A | All | 383 | Phase 3 | Argentina;Brazil;Chile;Mexico |
| 57 | NCT00091598 (ClinicalTrials.gov) | January 2004 | 10/9/2004 | ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension (PAH) | ARIES 1 and ARIES 2: Ambrisentan in PAH - A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Ambrisentan | Gilead Sciences | NULL | Completed | 18 Years | N/A | Both | 372 | Phase 3 | United States;Australia;Canada |
| 58 | NCT00423202 (ClinicalTrials.gov) | December 2003 | 17/1/2007 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension. | Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension. | Pulmonary Arterial Hypertension | Drug: ambrisentan | Gilead Sciences | NULL | Completed | 18 Years | N/A | Both | 186 | Phase 3 | NULL |
| 59 | NCT00423748 (ClinicalTrials.gov) | December 2003 | 17/1/2007 | Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension. | Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: ambrisentan | Gilead Sciences | NULL | Completed | 18 Years | N/A | Both | 186 | Phase 3 | NULL |
| 60 | NCT00424021 (ClinicalTrials.gov) | April 2003 | 17/1/2007 | Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension | An Open-Label, Long-Term Study of Ambrisentan in Pulmonary Hypertension Subjects Having Completed Myogen Study AMB-220 | Pulmonary Hypertension | Drug: ambrisentan | Gilead Sciences | NULL | Completed | 18 Years | N/A | All | 54 | Phase 2 | NULL |
| 61 | EUCTR2010-021572-29-FR (EUCTR) | 11/10/2011 | Testing medicines to treat children with pulmonary arterial hypertension (PAH)Testing medicines to treat teens with pulmonary arterial hypertension (PAH) | An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired - Safety FU Study of Amb in 8-17yr olds | Pulmonary Arterial Hypertension MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: VOLIBRIS® (ambrisentan) Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Trade Name: VOLIBRIS® (ambrisentan) Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Product Name: ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | United States;France;Hungary;Greece;Spain;Netherlands;Germany;Italy;Japan | |||
| 62 | EUCTR2010-019547-19-Outside-EU/EEA (EUCTR) | 16/03/2012 | Testing medicines to treat children with pulmonary arterial hypertension(PAH) | A randomized, open label study comparing safety and efficacyparameters for a high and a low dose of ambrisentan (adjustedfor body weight) for the treatment of pulmonary arterialhypertension in paediatric patients aged 8 years up to 18 years. - Efficacy and Safety of Ambrisentan in Children 8-17yrs | 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 MedDRA version: 14.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: VOLIBRIS Trade Name: VOLIBRIS™ tablets Product Name: Ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: VOLIBRIS Trade Name: VOLIBRIS™ tablets Product Name: Ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: VOLIBRIS | GlaxoSmithKline Research & Development Limited | NULL | NA | Female: yes Male: yes | 66 | Russian Federation;United States;Argentina;Brazil;Canada;Japan;Mexico |
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 | EUCTR2012-001642-17-IT (EUCTR) | 06/08/2014 | 12/09/2013 | An extension study of a drug to treat Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Subjects with inoperable Chronic Thromboembolic PulmonaryHypertension (CTEPH) MedDRA version: 17.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: Ambrisentan Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: Ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | United States;Spain;Korea, Democratic People's Republic of;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan | ||
| 2 | EUCTR2012-001646-18-IT (EUCTR) | 08/04/2014 | 26/06/2013 | Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH) | A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 16.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: Ambrisentan Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Spain;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 3 | NCT01894022 (ClinicalTrials.gov) | January 23, 2014 | 3/7/2013 | A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Hypertension | Drug: Ambrisentan 5 mg | GlaxoSmithKline | NULL | Terminated | 18 Years | 80 Years | All | 19 | Phase 3 | United States;Argentina;Austria;Canada;China;Czechia;Germany;Israel;Japan;Korea, Republic of;Mexico;Netherlands;Russian Federation;Saudi Arabia;Spain;United Kingdom;Czech Republic |
| 4 | EUCTR2012-001642-17-NL (EUCTR) | 16/12/2013 | 15/08/2013 | An extension study of a drug to treat Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 16.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;Japan;China;Korea, Republic of | |||
| 5 | EUCTR2012-001646-18-NL (EUCTR) | 27/09/2013 | 15/08/2013 | Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH) | A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 17.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: Ambrisentan Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;Japan;China;Korea, Republic of | |||
| 6 | EUCTR2012-001646-18-CZ (EUCTR) | 18/09/2013 | 09/07/2013 | Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH) | A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 17.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: Ambrisentan Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of | |||
| 7 | EUCTR2012-001642-17-CZ (EUCTR) | 18/09/2013 | 01/08/2013 | An extension study of a drug to treat Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 14.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 8 | EUCTR2012-001646-18-GB (EUCTR) | 02/09/2013 | 12/06/2013 | Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH) | A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 17.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: Ambrisentan Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of | |||
| 9 | EUCTR2012-001642-17-GB (EUCTR) | 02/09/2013 | 12/06/2013 | An extension study of a drug to treat Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 14.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 10 | NCT01884675 (ClinicalTrials.gov) | September 2013 | 20/6/2013 | Ambrisentan for Inoperable Chronic Thromboembolic Pulmonary Hypertension. | A Randomised, Multicentre, Double-Blind, Placebo-Controlled Study Of Ambrisentan In Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | Hypertension | Drug: Ambrisentan 5 mg;Drug: Placebo | GlaxoSmithKline | NULL | Terminated | 18 Years | 80 Years | All | 33 | Phase 3 | United States;Argentina;Austria;Canada;China;Czech Republic;Germany;Israel;Japan;Korea, Republic of;Mexico;Netherlands;Russian Federation;Saudi Arabia;Spain;United Kingdom |
| 11 | EUCTR2012-001646-18-DE (EUCTR) | 30/07/2013 | 05/06/2013 | Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH) | A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 17.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: Ambrisentan Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of | |||
| 12 | EUCTR2012-001642-17-DE (EUCTR) | 30/07/2013 | 05/06/2013 | An extension study of a drug to treat Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 17.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | United States;Saudi Arabia;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan | |||
| 13 | EUCTR2012-001642-17-AT (EUCTR) | 19/07/2013 | 04/06/2013 | An extension study of a drug to treat Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 14.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Germany;Netherlands;China;Japan;Korea, Republic of | |||
| 14 | EUCTR2012-001646-18-AT (EUCTR) | 11/07/2013 | 04/06/2013 | Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH) | A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 14.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: Ambrisentan Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of | |||
| 15 | EUCTR2012-001642-17-ES (EUCTR) | 26/04/2013 | 06/03/2013 | An extension study of a drug to treat Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). MedDRA version: 15.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: AMBRISENTAN Other descriptive name: ambrisentan | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 275 | United States;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden | |||
| 16 | EUCTR2012-001646-18-ES (EUCTR) | 25/04/2013 | 09/04/2013 | Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH) | A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) | Subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). MedDRA version: 14.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: Ambrisentan Other descriptive name: ambrisentan | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 275 | United States;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden |
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 | NCT02080637 (ClinicalTrials.gov) | July 2015 | 21/2/2014 | Ambrisentan in Single Ventricle | Safety, Pharmacokinetics (PK) and Hemodynamic Effects of Ambrisentan in Single Ventricle Pediatric Patients | Hypoplastic Left Heart Syndrome;Hypoplastic Right-sided Heart Complex | Drug: Ambrisentan;Other: Placebo | Kevin Hill | NULL | Completed | 24 Months | 120 Months | All | 16 | Phase 2 | United States |
| 2 | NCT01971580 (ClinicalTrials.gov) | August 2012 | 23/10/2013 | The Effects of Ambrisentan on Exercise Capacity in Fontan Patients | The Effects of Ambrisentan on Exercise Capacity in Fontan Patients | Single Ventricle Fontan Palliation | Drug: Ambrisentan | Washington University School of Medicine | NULL | Completed | 18 Years | 50 Years | All | 28 | Phase 4 | United States |
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 | NCT02080637 (ClinicalTrials.gov) | July 2015 | 21/2/2014 | Ambrisentan in Single Ventricle | Safety, Pharmacokinetics (PK) and Hemodynamic Effects of Ambrisentan in Single Ventricle Pediatric Patients | Hypoplastic Left Heart Syndrome;Hypoplastic Right-sided Heart Complex | Drug: Ambrisentan;Other: Placebo | Kevin Hill | NULL | Completed | 24 Months | 120 Months | All | 16 | Phase 2 | United States |