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61
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:466,薬物数:536(DrugBank:142),標的遺伝子数:110,標的パスウェイ数:210
Searched query = "Scleroderma", "Systemic sclerosis", "SSc", "dcSSc", "lcSSc"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
8 / 466 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-001882-28-DE13/10/201407/08/2014Drug treatment of patients with systemic sclerosis to prevent deterioration of pulmonary hypertensionEarly 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 gGmbHNULLNot RecruitingFemale: yes
Male: yes
38Phase 2Germany
2NCT02290613July 1, 201431/10/2014Early 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 EDITASystemic Sclerosis;Pulmonary HypertensionDrug: Ambrisentan;Drug: PlaceboHeidelberg UniversityGlaxoSmithKlineCompleted18 YearsN/AAll38Phase 2Germany
3NCT02169752September 20126/5/2014Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial HypertensionAmbrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial HypertensionPre-Pulmonary Atrial HypertensionDrug: AmbrisentanNational Jewish HealthNULLTerminated18 Years80 YearsAll7N/AUnited States
4NCT01093885February 201024/3/2010Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic SclerosisAn Open Label Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Treatment of Diffuse Systemic SclerosisSystemic Sclerosis;SclerodermaDrug: AmbrisentanUniversity of PennsylvaniaGilead SciencesCompleted19 Years90 YearsAll15N/AUnited States
5NCT01072669February 201019/2/2010Efficacy of Ambrisentan in Limited Scleroderma Patients in Improving Blood Flow to Hands or FeetEvaluation of the Effect of Ambrisentan on Digital Microvascular Flow in Patients With Systemic Sclerosis Using Laser Doppler Perfusion ImagingIschemiaDrug: ambrisentanSoumya ChatterjeeGilead SciencesCompleted18 Years70 YearsAll20N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT01042158January 20104/1/2010A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic SclerosisA Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic SclerosisPulmonary Arterial Hypertension;Systemic Sclerosis;Scleroderma Spectrum of Diseases;Connective Tissue Disease;Pulmonary HypertensionDrug: tadalafil and ambrisentan upfront combination therapyJohns Hopkins UniversityNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);Eli Lilly and Company;United Therapeutics;The Cleveland Clinic;University of Texas;Stanford UniversityCompleted18 YearsN/AAll25Phase 4United States
7NCT01051960March 200919/1/2010Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With AmbrisentanExercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan: A Prospective Single Center, Open Label, Pilot StudySystemic Sclerosis;Shortness of Breath;Pulmonary HypertensionDrug: AmbrisentanUniversity of California, Los AngelesGilead SciencesCompleted18 Years80 YearsAll12Phase 4United States
8NCT00725361June 200828/7/2008A 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, SystemicDrug: AmbrisentanStanford UniversityNULLCompleted18 YearsN/AAll20N/AUnited States

84. サルコイドーシス [臨床試験数:143,薬物数:221(DrugBank:79),標的遺伝子数:82,標的パスウェイ数:165
Searched query = "Sarcoidosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 143 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00851929November 200824/2/2009Ambrisentan (Letairis) for Sarcoidosis Associated Pulmonary HypertensionAmbrisentan (Letairis) for Sarcoidosis Associated Pulmonary HypertensionSarcoidosis;Pulmonary HypertensionDrug: AmbrisentanMedical University of South CarolinaGilead SciencesCompleted18 Years99 YearsAll16Phase 2/Phase 3United States

85. 特発性間質性肺炎 [臨床試験数:514,薬物数:377(DrugBank:108),標的遺伝子数:97,標的パスウェイ数:204
Searched query = "Idiopathic interstitial pneumonia", "IIPs", "Idiopathic pulmonary fibrosis", "IPF", "Usual interstitial pneumonia", "UIP", "Non-specific interstitial pneumonia", "NSIP", "Acute interstitial pneumonia", "AIP", "Diffuse alveolar damage", "DAD", "COP", "Organizing pneumonia", "OP", "Desquamative interstitial pneumonia", "DIP", "Respiratory bronchiolitis - associated interstitial lung disease", "RB-ILD", "Lymphocytic interstitial pneumonia", "LIP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
17 / 514 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-011169-98-CZ10/01/201129/11/2010ARTEMIS-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-PHARTEMIS-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: 12.1Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
MedDRA version: 12.1Level: LLTClassification code 10037400Term: Pulmonary hypertension
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
225Phase 3United Kingdom;Germany;Czech Republic;Italy;Austria
2EUCTR2008-004405-34-CZ13/09/201007/01/2009A 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-IPFA 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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLNot RecruitingFemale: yes
Male: yes
660Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
3EUCTR2009-011169-98-AT26/11/200925/08/2009ARTEMIS-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-PHARTEMIS-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: 12.0Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
MedDRA version: 12.0Level: LLTClassification code 10037400Term: Pulmonary hypertension
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czech Republic;United Kingdom;Germany;Italy;Austria
4EUCTR2009-011169-98-DE03/11/200906/08/2009ARTEMIS-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-PHARTEMIS-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: 12.0Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
MedDRA version: 12.0Level: LLTClassification code 10037400Term: Pulmonary hypertension
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czech Republic;United Kingdom;Germany;Italy;Austria
5EUCTR2009-011169-98-GB30/10/200901/09/2009ARTEMIS-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-PHARTEMIS-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: 12.0Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
MedDRA version: 12.0Level: LLTClassification code 10037400Term: Pulmonary hypertension
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Trade Name: Letairis
INN or Proposed INN: Ambrisentan
Gilead Sciences, IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czech Republic;Germany;United Kingdom;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2009-011169-98-IT22/09/200921/09/2009A 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 - NDA 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: 9.1Level: LLTClassification code 10021240
MedDRA version: 9.1Level: LLTClassification code 10037400
Trade Name: Letairis
Trade Name: Letairis
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czech Republic;United Kingdom;Germany;Italy;Austria
7EUCTR2008-004405-34-IE08/09/200907/01/2009A 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) - ARTEMISA 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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
8EUCTR2008-004405-34-IT03/08/200927/07/2009A 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-IPFA 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: 12.0Level: LLTClassification code 10021240Term: Idiopathic pulmonary fibrosis
Trade Name: VOLIBRIS
INN or Proposed INN: Ambrisentan
Trade Name: VOLIBRIS
INN or Proposed INN: Ambrisentan
Gilead Sciences IncorporatedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
9NCT00879229July 20098/4/2009ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary FibrosisA 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 HypertensionIdiopathic Pulmonary Fibrosis;Pulmonary HypertensionDrug: Ambrisentan;Drug: PlaceboGilead SciencesNULLTerminated35 Years80 YearsAll40Phase 3United States;Australia;Austria;Canada;Germany;Italy;United Kingdom;Belgium;Ireland;Israel
10EUCTR2008-004405-34-GB08/06/200928/04/2009ARTEMIS-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-IPFARTEMIS-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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2008-004405-34-NL04/06/200910/03/2009A 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-IPFA 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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
660Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
12EUCTR2008-004405-34-ES27/03/200928/01/2009ARTEMIS: 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). - ARTEMISARTEMIS: 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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Ireland;Spain;Italy;Austria
13EUCTR2008-004405-34-AT13/03/200921/01/2009A 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) - ARTEMISA 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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
14EUCTR2008-004405-34-BE09/03/200922/01/2009A 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-IPFA 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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLNot RecruitingFemale: yes
Male: yes
660Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
15EUCTR2008-004405-34-FR09/02/200916/03/2009A 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) - ARTEMISA 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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT00768300December 20087/10/2008(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPFARTEMIS-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 FibrosisDrug: Ambrisentan;Drug: PlaceboGilead SciencesNULLTerminated40 Years80 YearsAll494Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czech Republic;France;Germany;Ireland;Israel;Italy;Mexico;Netherlands;Peru;Poland;Spain;Switzerland;United Kingdom
17EUCTR2008-004405-34-DE14/01/2009A 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-IPFA 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: 9.1Level: LLTClassification code 10021240Term: 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 IncorporatedNULLNot RecruitingFemale: yes
Male: yes
660Phase 3France;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:1,083,薬物数:667(DrugBank:122),標的遺伝子数:98,標的パスウェイ数:185
Searched query = "Pulmonary arterial hypertension", "PAH", "IPAH", "HPAH", "Eisenmenger syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
61 / 1,083 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04528056August 1, 202014/8/2020Pilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial HypertensionPilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Sulfasalazine;Drug: Ambrisentan;Drug: Sulfasalazine's placebo;Drug: Ambrisentan's placeboRenJi HospitalNULLRecruiting18 Years75 YearsAll80Phase 1/Phase 2China
2EUCTR2019-001699-12-GB27/08/201930/07/2019Relative bioavailability study of marketed and lower dose ambrisentan in healthy adult participantsAn 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: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
24Phase 1United Kingdom
3NCT02999906October 201719/12/2016Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial HypertensionA 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 HypertensionPulmonary Arterial HypertensionDrug: Oral Treprostinil;Drug: PlaceboUnited TherapeuticsNULLWithdrawn18 Years79 YearsAll0Phase 3NULL
4NCT02885012June 20163/5/2016Crossover Study From Macitentan or Bosentan Over to AmbrisentanA 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 HypertensionDrug: AmbrisentanMedical University of South CarolinaOchsner Health SystemTerminated18 Years80 YearsAll3Phase 4United States
5NCT03809156April 26, 20169/1/2019Upfront Combination Pulmonary Arterial Hypertension TherapyUpfront Riociguat and Ambrisentan Combination Therapy for Pulmonary Arterial Hypertension: A Safety and Efficacy Pilot StudyPulmonary HypertensionDrug: Riociguat Oral ProductUniversity of CalgaryBayerRecruiting18 YearsN/AAll20Phase 4Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02253394September 201517/9/2014The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension StudyThe Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (The CAPS-PAH Study)Pulmonary Arterial HypertensionDrug: Ambrisentan plus Spironolactone;Drug: Ambrisentan plus PlaceboBrigham and Women's HospitalGilead SciencesTerminated18 YearsN/AAll2Phase 4United States
7ChiCTR-OON-170135212015-02-012017-11-24Transition from ambrisentan to bosentan in pulmonary arterial hypertension: A single center prospective studyTransition from ambrisentan to bosentan in pulmonary arterial hypertension: A single center prospective study pulmonary arterial hypertensionambrisentan group:oral ambrisentan;bosentan group:oral bosentan;Shanghai Pulmonary HospitalNULLCompletedMaleambrisentan group:12;bosentan group:8;China
8EUCTR2014-001882-28-DE13/10/201407/08/2014Drug treatment of patients with systemic sclerosis to prevent deterioration of pulmonary hypertensionEarly 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 gGmbHNULLNot RecruitingFemale: yes
Male: yes
38Phase 2Germany
9NCT02290613July 1, 201431/10/2014Early 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 EDITASystemic Sclerosis;Pulmonary HypertensionDrug: Ambrisentan;Drug: PlaceboHeidelberg UniversityGlaxoSmithKlineCompleted18 YearsN/AAll38Phase 2Germany
10NCT01808313December 1, 201228/2/2013Efficacy 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 DiseaseDrug: ambrisentanGlaxoSmithKlineNULLCompleted18 Years75 YearsAll134Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT02169752September 20126/5/2014Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial HypertensionAmbrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial HypertensionPre-Pulmonary Atrial HypertensionDrug: AmbrisentanNational Jewish HealthNULLTerminated18 Years80 YearsAll7N/AUnited States
12EUCTR2010-021572-29-IT19/09/201107/02/2011An 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 - AMB114588An 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: 9.1Level: LLTClassification code 10064908
MedDRA version: 9.1Level: LLTClassification code 10064910
MedDRA version: 9.1Level: LLTClassification 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, LtdNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Greece;Spain;Netherlands;Germany;Italy
13EUCTR2010-021572-29-NL19/07/201111/11/2010An 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 desiredAn 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: 12.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065150Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065151Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065152Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1Level: PTClassification code 10064911Term: 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, LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Hungary;Germany;Netherlands;Spain;Italy;Greece
14NCT01342952June 21, 201126/4/2011Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529An 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 DesiredHypertension, PulmonaryDrug: AmbrisentanGlaxoSmithKlineNULLActive, not recruiting8 Years18 YearsAll66Phase 2United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Mexico;Netherlands
15NCT01330108May 20114/4/2011Safely Change From Bosentan to Ambrisentan in Pulmonary HypertensionSafely Change From Bosentan to Ambrisentan in Pulmonary HypertensionPulmonary Arterial HypertensionDrug: ambrisentanUniversity of Alabama at BirminghamNULLCompleted19 YearsN/AAll32Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16JPRN-UMIN0000054642011/04/0119/04/2011Drug interactions and effects of combination therapy for pulmonary arterial hypertension pulmonary arterial hypertensionphase 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 MedicineUniversity of ShizuokaRecruiting20years-oldNot applicableMale and Female15Not appl1cableJapan
17EUCTR2010-021572-29-ES19/01/201117/11/2010Estudio 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: 13Level: LLTClassification code 10064911Term: Hipertensión arterial pulmonar
MedDRA version: 13Level: LLTClassification code 10065150Term: Hipertensión pulmonar arterial primaria asociada
MedDRA version: 13Level: LLTClassification code 10065151Term: Hipertensión pulmonar arterial primaria idiopática
MedDRA version: 13Level: LLTClassification code 10065152Term: Hipertensión pulmonar arterial primaria familiar
MedDRA version: 13Level: PTClassification code 10064911Term: 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.ANULLNot RecruitingFemale: yes
Male: yes
66Hungary;Greece;Spain;Netherlands;Germany;Italy
18EUCTR2010-021572-29-DE11/01/201110/11/2010An 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 desiredAn 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: 16.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 16.0Level: LLTClassification code 10065151Term: Idiopathic pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 16.0Level: LLTClassification code 10065150Term: Associated with pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 16.0Level: LLTClassification code 10065152Term: Familial pulmonary arterial hypertensionSystem 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, LtdNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Greece;Spain;Netherlands;Germany;Italy
19EUCTR2010-021572-29-HU10/01/201122/11/2010An 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 desiredAn 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: 12.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065150Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065151Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065152Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1Level: PTClassification code 10064911Term: 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, LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Hungary;Germany;Netherlands;Spain;Italy;Greece
20NCT01332331January 4, 201124/3/2011Efficacy and Safety of Ambrisentan in Children 8-18yrsA 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 YearsHypertension, PulmonaryDrug: Ambrisentan - low dose;Drug: Ambrisentan - high doseGlaxoSmithKlineNULLTerminated8 Years18 YearsAll41Phase 2United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Greece;Mexico;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT01406327December 14, 201028/7/2011Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)Hypertension, PulmonaryDrug: AmbrisentanGlaxoSmithKlineNULLCompletedN/AN/AAll900NULL
22EUCTR2010-019547-19-IT30/11/201014/12/2010A 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 - AMB112529A 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: 9.1Level: LLTClassification code 10064911
MedDRA version: 9.1Level: LLTClassification code 10065150
MedDRA version: 9.1Level: LLTClassification code 10065151
MedDRA version: 9.1Level: LLTClassification 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, LtdNULLNot RecruitingFemale: yes
Male: yes
66France;Hungary;Greece;Spain;Germany;Netherlands;Italy
23EUCTR2010-021572-29-GR23/11/201026/10/2010An 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 desiredAn 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: 12.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065150Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065151Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065152Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1Level: PTClassification code 10064911Term: 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, LtdNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Germany;Netherlands;Spain;Italy;Greece
24EUCTR2009-011150-17-BE15/11/201014/06/2010Study 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: 16.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
614United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
25EUCTR2010-019547-19-FR12/11/201023/08/2010A 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 Level: LLT Classification code 10065150 Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1 Level: LLT Classification code 10065151 Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1 Level: LLT Classification code 10065152 Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension
GlaxoSmithKline Research & Development, LtdNULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Hungary;Greece;Spain;Germany;Netherlands;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2010-019547-19-NL05/11/201001/07/2010A 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: 12.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065150Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065151Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065152Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1Level: PTClassification code 10064911Term: 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, LtdNULLNot RecruitingFemale: yes
Male: yes
66Phase 2France;Hungary;Greece;Spain;Germany;Netherlands;Italy
27EUCTR2010-019547-19-HU15/10/201012/07/2010A 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: 12.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065150Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065151Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065152Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1Level: PTClassification code 10064911Term: 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, LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Hungary;Germany;Netherlands;France;Spain;Italy;Greece
28EUCTR2010-019547-19-ES06/10/201015/07/2010 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 10064911 Term: Hipertensión arterial pulmonar
MedDRA version: 13 Level: LLT Classification code 10065150 Term: Hipertensión pulmonar arterial primaria asociada
MedDRA version: 13 Level: LLT Classification code 10065151 Term: Hipertensión pulmonar arterial primaria idiopática
MedDRA version: 13 Level: LLT Classification code 10065152 Term: Hipertensión pulmonar arterial primaria familiar
GlaxoSmithKline, S.A.NULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;Hungary;Greece;Spain;Germany;Netherlands;Italy
29EUCTR2010-019547-19-DE05/10/201014/07/2010A 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: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1Level: LLTClassification code 10065151Term: Idiopathic pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1Level: LLTClassification code 10065150Term: Associated with pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1Level: LLTClassification code 10065152Term: Familial pulmonary arterial hypertensionSystem 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, LtdNULLNot RecruitingFemale: yes
Male: yes
66Phase 2France;Hungary;Greece;Spain;Netherlands;Germany;Italy
30NCT01178073October 1, 201015/7/2010A 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, PulmonaryDrug: ambrisentan;Drug: tadalafilGlaxoSmithKlineGilead SciencesCompleted18 Years75 YearsAll610Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Greece;Italy;Japan;Netherlands;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2009-011150-17-FR24/09/201013/08/2010AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITIONAMBITION: 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 Classification code 10064911 Term: Pulmonary arterial hypertension
GlaxoSmithKline Research & Development LimitedNULLNot Recruiting Female: yes
Male: yes
352 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesFrance;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
32EUCTR2009-011150-17-NL26/08/201026/05/2010Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial HypertensionAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
545Germany;United Kingdom;Netherlands;France;Spain;Italy;Japan;Greece;Austria;Sweden
33EUCTR2009-011150-17-DE16/08/201003/08/2010Study 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: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
614United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Sweden
34EUCTR2009-011150-17-GB11/08/201022/06/2010Study 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
GlaxoSmithKline R&D LtdNULLNot Recruiting Female: yes
Male: yes
545 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesFrance;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
35EUCTR2009-011150-17-IT06/08/201009/08/2010AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITIONAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypertension
MedDRA version: 9.1Level: LLTClassification code 10064911
Trade Name: VOLIBRIS
Trade Name: CIALIS
INN or Proposed INN: Tadalafil
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
352France;Greece;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2009-011150-17-AT03/08/201022/06/2010Study 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: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
545United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
37EUCTR2009-011150-17-GR16/07/201014/07/2010AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITIONAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 13.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
352France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
38EUCTR2010-019547-19-GR16/07/201030/06/2010A 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: 12.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065150Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065151Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10065152Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1Level: PTClassification code 10064911Term: 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, LtdNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Germany;Netherlands;France;Spain;Italy;Greece
39EUCTR2009-011150-17-SE14/07/201018/06/2010Study 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: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
545United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
40EUCTR2009-011150-17-ES13/07/201002/06/2010AMBITION: 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 - AMBITIONAMBITION: 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: 11Level: PTClassification code 10064911Term: Hipertensión arterial pulmonar
MedDRA version: 11Level: LLTClassification code 10064911Term: 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.NULLNot RecruitingFemale: yes
Male: yes
352France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT01042158January 20104/1/2010A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic SclerosisA Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic SclerosisPulmonary Arterial Hypertension;Systemic Sclerosis;Scleroderma Spectrum of Diseases;Connective Tissue Disease;Pulmonary HypertensionDrug: tadalafil and ambrisentan upfront combination therapyJohns Hopkins UniversityNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);Eli Lilly and Company;United Therapeutics;The Cleveland Clinic;University of Texas;Stanford UniversityCompleted18 YearsN/AAll25Phase 4United States
42NCT01338636September 200818/4/2011An 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 HypertensionExercise-induced Pulmonary Arterial HypertensionDrug: AmbrisentanBrigham and Women's HospitalGilead SciencesCompleted18 YearsN/AAll30Phase 4United States
43NCT00617305April 20086/2/2008Study 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 InhibitorPulmonary Arterial HypertensionDrug: Ambrisentan;Drug: Placebo;Drug: Sildenafil;Drug: TadalafilGilead SciencesNULLCompleted16 Years75 YearsAll38Phase 4United States
44EUCTR2005-000812-29-IT15/11/200515/02/2006ARIES-1 - Ambrisentan in PAH A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial HypertensionARIES-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: 6.1Level: PTClassification code 10037400
Product Name: AmbrisentanMYOGEN INC.NULLNot RecruitingFemale: yes
Male: yes
186Phase 3Hungary;Germany;Belgium;Spain;Italy
45EUCTR2005-001193-28-AT08/11/200504/10/2005ARIES-320/321-E A Long-Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 or AMB-321 - 320/321-EARIES-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 HypertensionProduct 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, IncNULLNot RecruitingFemale: yes
Male: yes
372Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2005-000812-29-AT08/11/200504/10/2005ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1ARIES-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 HypertensionProduct 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, IncNULLNot RecruitingFemale: yes
Male: yes
186Phase 3Hungary;Belgium;Spain;Austria;Germany;Italy
47EUCTR2005-000812-29-DE07/11/200502/03/2007ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1ARIES-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 HypertensionProduct 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, IncNULLNot RecruitingFemale: yes
Male: yes
186Phase 3Hungary;Germany;Belgium;Spain;Italy
48EUCTR2005-000812-29-ES21/10/200519/09/2005ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1ARIES-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 HypertensionProduct 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, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
186Phase 3Hungary;Germany;Belgium;Spain;Italy
49EUCTR2005-001564-31-DE07/10/200508/07/2005A 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 - NAA 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: 7.0Level: lowClassification 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Germany
50EUCTR2005-000812-29-HU21/09/200511/08/2005Ambrisentan in PAH - A Phase III, Randomised, Double- Blind, Placebo- Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension - ARIES-1Ambrisentan 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: 7.0Level: lowClassification 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
186Phase 3Hungary;Germany;Belgium;Spain;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2005-000812-29-BE16/09/200508/02/2006ARIES-1 Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension” - ARIES-1ARIES-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 HypertensionProduct 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, IncNULLNot RecruitingFemale: yes
Male: yes
186Phase 3Hungary;Germany;Belgium;Spain;Italy
52EUCTR2005-001564-31-BE16/08/200515/12/2005A 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 - NAA 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: 7.0Level: lowClassification 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.NULLNot RecruitingFemale: yes
Male: yes
30Phase 2Belgium;Germany
53NCT00593905July 20053/1/2008Pharmacogenomics in Pulmonary Arterial HypertensionPharmacogenomics 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 GenesPulmonary Arterial Hypertension;Pulmonary Hypertension;PAH WHO Group IDrug: Sitaxsentan;Drug: Bosentan, AmbrisentanWest Penn Allegheny Health SystemNational 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;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 Hospital Case Medical Center;University of Colorado, Denver;University of Michigan;University of Pittsburgh;University of Southern California;The University of Texas, 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 PhysiciansRecruitingN/AN/ABoth1300N/AUnited States
54NCT00423592May 200517/1/2007Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial HypertensionA 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 AbnormalitiesPulmonary HypertensionDrug: ambrisentanGilead SciencesNULLCompleted12 Years75 YearsAll36Phase 2NULL
55NCT00578786February 200419/12/2007A 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 HypertensionDrug: ambrisentanGilead SciencesNULLCompleted18 YearsN/AAll383Phase 3Argentina;Brazil;Chile;Mexico
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT00091598January 200410/9/2004ARIES - 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 HypertensionPulmonary HypertensionDrug: AmbrisentanGilead SciencesNULLCompleted18 YearsN/ABoth372Phase 3United States;Australia;Canada
57NCT00423202December 200317/1/2007A 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 HypertensionDrug: ambrisentanGilead SciencesNULLCompleted18 YearsN/ABoth186Phase 3NULL
58NCT00423748December 200317/1/2007Study 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 HypertensionPulmonary Arterial HypertensionDrug: ambrisentanGilead SciencesNULLCompleted18 YearsN/ABoth186Phase 3NULL
59NCT00424021April 200317/1/2007Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial HypertensionAn Open-Label, Long-Term Study of Ambrisentan in Pulmonary Hypertension Subjects Having Completed Myogen Study AMB-220Pulmonary HypertensionDrug: ambrisentanGilead SciencesNULLCompleted18 YearsN/AAll54Phase 2NULL
60EUCTR2010-019547-19-Outside-EU/EEA16/03/2012Testing 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: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1Level: LLTClassification code 10065150Term: Associated with pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1Level: LLTClassification code 10065152Term: Familial pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1Level: LLTClassification code 10065151Term: Idiopathic pulmonary arterial hypertensionSystem 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 LimitedNULLNAFemale: yes
Male: yes
66Russian Federation;United States;Argentina;Brazil;Canada;Japan;Mexico
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2010-021572-29-FR11/10/2011Testing 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: 14.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0Level: LLTClassification code 10065150Term: Associated with pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0Level: LLTClassification code 10065152Term: Familial pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0Level: LLTClassification code 10065151Term: Idiopathic pulmonary arterial hypertensionSystem 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
66Phase 2United States;France;Hungary;Greece;Spain;Netherlands;Germany;Italy;Japan

88. 慢性血栓塞栓性肺高血圧症 [臨床試験数:145,薬物数:112(DrugBank:22),標的遺伝子数:13,標的パスウェイ数:52
Searched query = "Chronic thromboembolic pulmonary hypertension", "CTEPH", "Idiopathic chronic pulmonary thromboembolism"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
16 / 145 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-001642-17-IT06/08/201412/09/2013An 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: 17.0Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
160Phase 3United 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
2EUCTR2012-001646-18-IT08/04/201426/06/2013Study 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: 16.0Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
160Phase 3Spain;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of
3NCT01894022January 23, 20143/7/2013A 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)HypertensionDrug: Ambrisentan 5 mgGlaxoSmithKlineNULLTerminated18 Years80 YearsAll19Phase 3United States;Argentina;Austria;Canada;China;Czechia;Germany;Israel;Japan;Korea, Republic of;Mexico;Netherlands;Russian Federation;Saudi Arabia;Spain;United Kingdom;Czech Republic
4EUCTR2012-001642-17-NL16/12/201315/08/2013An 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: 16.0Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
160Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;Japan;China;Korea, Republic of
5EUCTR2012-001646-18-NL27/09/201315/08/2013Study 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: 17.0Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
160Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;Japan;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2012-001646-18-CZ18/09/201309/07/2013Study 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: 17.0Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
160Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of
7EUCTR2012-001642-17-CZ18/09/201301/08/2013An 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: 14.1Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
160Phase 3Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of
8EUCTR2012-001642-17-GB02/09/201312/06/2013An 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]
GlaxoSmithKline Research & Developement LtdNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSpain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of
9EUCTR2012-001646-18-GB02/09/201312/06/2013Study 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: 17.0Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
160Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of
10NCT01884675September 201320/6/2013Ambrisentan 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).HypertensionDrug: Ambrisentan 5 mg;Drug: PlaceboGlaxoSmithKlineNULLTerminated18 Years80 YearsAll33Phase 3United States;Argentina;Austria;Canada;China;Czech Republic;Germany;Israel;Japan;Korea, Republic of;Mexico;Netherlands;Russian Federation;Saudi Arabia;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2012-001646-18-DE30/07/201305/06/2013Study 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: 17.0Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
160Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of
12EUCTR2012-001642-17-DE30/07/201305/06/2013An 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: 17.1Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
160United States;Saudi Arabia;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan
13EUCTR2012-001642-17-AT19/07/201304/06/2013An 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: 14.1Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
160Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Germany;Netherlands;China;Japan;Korea, Republic of
14EUCTR2012-001646-18-AT11/07/201304/06/2013Study 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: 14.1Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem 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 LtdNULLNot RecruitingFemale: yes
Male: yes
160Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of
15EUCTR2012-001642-17-ES26/04/201306/03/2013An 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: 15.1Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem 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.NULLNot RecruitingFemale: yes
Male: yes
275United States;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2012-001646-18-ES25/04/201309/04/2013Study 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: 14.1Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem 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.NULLNot RecruitingFemale: yes
Male: yes
275United 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:47,薬物数:54(DrugBank:23),標的遺伝子数:32,標的パスウェイ数:66
Searched query = "Single Ventricle", "SV", "Single ventricle heart defect", "Univentricular heart", "UVH", "Single ventricular circulation syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 47 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02080637July 201521/2/2014Ambrisentan in Single VentricleSafety, Pharmacokinetics (PK) and Hemodynamic Effects of Ambrisentan in Single Ventricle Pediatric PatientsHypoplastic Left Heart Syndrome;Hypoplastic Right-sided Heart ComplexDrug: Ambrisentan;Other: PlaceboKevin HillNULLCompleted24 Months120 MonthsAll16Phase 2United States
2NCT01971580August 201223/10/2013The Effects of Ambrisentan on Exercise Capacity in Fontan PatientsThe Effects of Ambrisentan on Exercise Capacity in Fontan PatientsSingle Ventricle Fontan PalliationDrug: AmbrisentanWashington University School of MedicineNULLCompleted18 Years50 YearsAll28Phase 4United States

211. 左心低形成症候群 [臨床試験数:20,薬物数:28(DrugBank:9),標的遺伝子数:5,標的パスウェイ数:13
Searched query = "Hypoplastic left heart syndrome", "HLHS"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 20 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02080637July 201521/2/2014Ambrisentan in Single VentricleSafety, Pharmacokinetics (PK) and Hemodynamic Effects of Ambrisentan in Single Ventricle Pediatric PatientsHypoplastic Left Heart Syndrome;Hypoplastic Right-sided Heart ComplexDrug: Ambrisentan;Other: PlaceboKevin HillNULLCompleted24 Months120 MonthsAll16Phase 2United States