86. 肺動脈性肺高血圧症 Pulmonary arterial hypertension Clinical trials / Disease details


臨床試験数 : 1,205 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193

  
62 trials found
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PhaseCountries
1NCT04972656
(ClinicalTrials.gov)
September 5, 20229/7/2021Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial HypertensionTreatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension: a Multicenter, Randomized, Double-blind, Placebo-controlled StudyPulmonary Arterial HypertensionDrug: Ambrisentan;Drug: PlaceboNanjing First Hospital, Nanjing Medical UniversityTianjin Medical University General HospitalRecruiting18 YearsN/AAll420N/AChina
2NCT04528056
(ClinicalTrials.gov)
August 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
3EUCTR2019-001699-12-GB
(EUCTR)
27/08/201930/07/2019Relative 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ambrisentan Tablet
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: (S)-2-(4,6-dimethylpyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropanoic acid
Trade Name: Volibris
Product Name: Ambrisentan 5mg film-coated tablets [marketed product]
INN or Proposed INN: AMBRISENTAN
Other descriptive name: (S)-2-(4,6-dimethylpyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropanoic acid
GlaxoSmithKline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
24Phase 1United Kingdom
4NCT02999906
(ClinicalTrials.gov)
October 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
5NCT02885012
(ClinicalTrials.gov)
June 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
6NCT03809156
(ClinicalTrials.gov)
April 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
7NCT02253394
(ClinicalTrials.gov)
September 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
8ChiCTR-OON-17013521
2015-02-012017-11-24Transition 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
9EUCTR2014-001882-28-DE
(EUCTR)
13/10/201407/08/2014Drug 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
10NCT02290613
(ClinicalTrials.gov)
July 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
11NCT01808313
(ClinicalTrials.gov)
December 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
12NCT02169752
(ClinicalTrials.gov)
September 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
13EUCTR2010-021572-29-IT
(EUCTR)
19/09/201107/02/2011An 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: 9.1;Level: LLT;Classification code 10064908
MedDRA version: 9.1;Classification code 10064910
MedDRA version: 9.1;Classification code 10064909
Trade Name: VOLIBRIS
INN or Proposed INN: ambrisentan
Trade Name: VOLIBRIS
INN or Proposed INN: ambrisentan
INN or Proposed INN: Ambrisentan
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Greece;Spain;Netherlands;Germany;Italy
14EUCTR2010-021572-29-NL
(EUCTR)
19/07/201111/11/2010An 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: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Product Name: ambrisentan
Product Code: GSK1325760
GlaxoSmithKline Research & Development, LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Hungary;Germany;Netherlands;Spain;Italy;Greece
15NCT01342952
(ClinicalTrials.gov)
June 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: AmbrisentanGlaxoSmithKlineNULLCompleted8 Years18 YearsAll38Phase 2United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Mexico;Netherlands
16NCT01330108
(ClinicalTrials.gov)
May 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
17JPRN-UMIN000005464
2011/04/0119/04/2011Drug interactions and effects of combination therapy for pulmonary arterial hypertensionDrug interactions and effects of combination therapy for pulmonary arterial hypertension - Drug interactions and effects of PAH combination therapy 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 applicableJapan
18EUCTR2010-021572-29-ES
(EUCTR)
19/01/201117/11/2010Estudio 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: 13;Level: LLT;Classification code 10064911;Term: Hipertensión arterial pulmonar
MedDRA version: 13;Classification code 10065150;Term: Hipertensión pulmonar arterial primaria asociada
MedDRA version: 13;Classification code 10065151;Term: Hipertensión pulmonar arterial primaria idiopática
MedDRA version: 13;Classification code 10065152;Term: Hipertensión pulmonar arterial primaria familiar
MedDRA version: 13;Level: PT;Term: Hipertensión arterial pulmonar
Trade Name: VOLIBRIS 10 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
GlaxoSmithKline, S.ANULLNot RecruitingFemale: yes
Male: yes
66Hungary;Greece;Spain;Netherlands;Germany;Italy
19EUCTR2010-021572-29-DE
(EUCTR)
11/01/201110/11/2010An 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: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 16.0;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Phase 3France;Hungary;Greece;Spain;Netherlands;Germany;Italy
20EUCTR2010-021572-29-HU
(EUCTR)
10/01/201122/11/2010An 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: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Product Name: ambrisentan
Product Code: GSK1325760
GlaxoSmithKline Research & Development, LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Hungary;Germany;Netherlands;Spain;Italy;Greece
21NCT01332331
(ClinicalTrials.gov)
January 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
22NCT01406327
(ClinicalTrials.gov)
December 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
23EUCTR2010-019547-19-IT
(EUCTR)
30/11/201014/12/2010A 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: 9.1;Level: LLT;Classification code 10064911
MedDRA version: 9.1;Classification code 10065150
MedDRA version: 9.1;Classification code 10065151
MedDRA version: 9.1;Classification code 10065152
Trade Name: VOLIBRIS
INN or Proposed INN: AMBRISENTAN
Trade Name: VOLIBRIS
INN or Proposed INN: AMBRISENTAN
Product Name: AMBRISENTAN
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66France;Hungary;Greece;Spain;Germany;Netherlands;Italy
24EUCTR2010-021572-29-GR
(EUCTR)
23/11/201026/10/2010An 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: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Germany;Netherlands;Spain;Italy;Greece
25EUCTR2009-011150-17-BE
(EUCTR)
15/11/201014/06/2010Study 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: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
614United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
26EUCTR2010-019547-19-FR
(EUCTR)
12/11/201023/08/2010A 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;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
GlaxoSmithKline Research & Development, LtdNULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Hungary;Greece;Spain;Germany;Netherlands;Italy
27EUCTR2010-019547-19-NL
(EUCTR)
05/11/201001/07/2010A 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: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Phase 2France;Hungary;Greece;Spain;Germany;Netherlands;Italy
28EUCTR2010-019547-19-HU
(EUCTR)
15/10/201012/07/2010A 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: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Product Name: ambrisentan
Product Code: GSK1325760
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Phase 2France;Hungary;Greece;Spain;Germany;Netherlands;Italy
29EUCTR2010-019547-19-ES
(EUCTR)
06/10/201015/07/2010 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 10065150;Term: Hipertensión pulmonar arterial primaria asociada
MedDRA version: 13;Classification code 10065151;Term: Hipertensión pulmonar arterial primaria idiopática
MedDRA version: 13;Classification code 10065152;Term: Hipertensión pulmonar arterial primaria familiar
Trade Name: VOLIBRIS 10 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
GlaxoSmithKline, S.A.NULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Hungary;Greece;Spain;Germany;Netherlands;Italy
30EUCTR2010-019547-19-DE
(EUCTR)
05/10/201014/07/2010A 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: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Phase 2France;Hungary;Greece;Spain;Netherlands;Germany;Italy
31NCT01178073
(ClinicalTrials.gov)
October 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
32EUCTR2009-011150-17-FR
(EUCTR)
24/09/201013/08/2010AMBITION: 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;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline Research & Development LimitedNULLNot Recruiting Female: yes
Male: yes
352 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
33EUCTR2009-011150-17-NL
(EUCTR)
26/08/201026/05/2010Ambrisentan 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: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Virus Diseases [C02]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
545Phase 4France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden
34EUCTR2009-011150-17-DE
(EUCTR)
16/08/201003/08/2010Study 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: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
614United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Sweden
35EUCTR2009-011150-17-GB
(EUCTR)
11/08/201022/06/2010Study 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
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 Recruiting Female: yes
Male: yes
545 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
36EUCTR2009-011150-17-IT
(EUCTR)
06/08/201009/08/2010AMBITION: 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: 9.1;Level: LLT;Classification 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
37EUCTR2009-011150-17-AT
(EUCTR)
03/08/201022/06/2010Study 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;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
38EUCTR2009-011150-17-GR
(EUCTR)
16/07/201014/07/2010AMBITION: 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: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
352France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
39EUCTR2010-019547-19-GR
(EUCTR)
16/07/201030/06/2010A 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: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Germany;Netherlands;France;Spain;Italy;Greece
40EUCTR2009-011150-17-SE
(EUCTR)
14/07/201018/06/2010Study 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: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
545United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
41EUCTR2009-011150-17-ES
(EUCTR)
13/07/201002/06/2010AMBITION: 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: 11;Level: PT;Classification code 10064911;Term: Hipertensión arterial pulmonar
MedDRA version: 11;Level: LLT;Term: Hipertensión arterial pulmonar
Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
Trade Name: CIALIS 20 mg comprimidos recubiertos con película
INN or Proposed INN: TADALAFILO
Other descriptive name: TADALAFIL
GlaxoSmithKline,S.A.NULLNot RecruitingFemale: yes
Male: yes
352France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
42NCT01042158
(ClinicalTrials.gov)
January 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
43NCT01338636
(ClinicalTrials.gov)
September 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
44NCT00617305
(ClinicalTrials.gov)
April 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
45EUCTR2005-000812-29-IT
(EUCTR)
15/11/200515/02/2006ARIES-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: 6.1;Level: PT;Classification code 10037400
Product Name: AmbrisentanMYOGEN INC.NULLNot RecruitingFemale: yes
Male: yes
186Phase 3Hungary;Germany;Belgium;Spain;Italy
46EUCTR2005-001193-28-AT
(EUCTR)
08/11/200504/10/2005ARIES-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
47EUCTR2005-000812-29-AT
(EUCTR)
08/11/200504/10/2005ARIES-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
48EUCTR2005-000812-29-DE
(EUCTR)
07/11/200502/03/2007ARIES-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
49EUCTR2005-000812-29-ES
(EUCTR)
21/10/200519/09/2005ARIES-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, IncNULLNot RecruitingFemale: yes
Male: yes
186Phase 3Hungary;Belgium;Spain;Austria;Germany;Italy
50EUCTR2005-001564-31-DE
(EUCTR)
07/10/200508/07/2005A 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: 7.0;Level: low;Classification code 10037400
Product Name: Ambrisentan
Product Code: BSF 208075
INN or Proposed INN: Ambrisentan
Product Name: Ambrisentan
Product Code: BSF 208075
INN or Proposed INN: Ambrisentan
Product Name: Ambrisentan
Product Code: BSF 208075
INN or Proposed INN: Ambrisentan
Myogen Inc.NULLNot RecruitingFemale: yes
Male: yes
30Phase 2Belgium;Germany
51EUCTR2005-000812-29-HU
(EUCTR)
21/09/200511/08/2005Ambrisentan in PAH - A Phase III, Randomised, Double- Blind, Placebo- Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension - ARIES-1 Ambrisentan in PAH - A Phase III, Randomised, Double- Blind, Placebo- Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension - ARIES-1 Pulmonary Arterial Hypertension
MedDRA version: 7.0;Level: low;Classification code 10037400
Product Name: Ambrisentan
Product Code: BSF 208075
INN or Proposed INN: Ambrisentan
Product Name: Ambrisentan
Product Code: BSF 208075
INN or Proposed INN: Ambrisentan
Product Name: Ambrisentan
Product Code: BSF 208075
INN or Proposed INN: Ambrisentan
Myogen, Inc.NULLNot RecruitingFemale: yes
Male: yes
186Phase 3Hungary;Belgium;Spain;Austria;Germany;Italy
52EUCTR2005-000812-29-BE
(EUCTR)
16/09/200508/02/2006ARIES-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
53EUCTR2005-001564-31-BE
(EUCTR)
16/08/200515/12/2005A 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: 7.0;Level: low;Classification code 10037400
Product Name: Ambrisentan
Product Code: BSF 208075 or LU 208075
INN or Proposed INN: Ambrisentan
INN or Proposed INN: Ambrisentan
INN or Proposed INN: Ambrisentan
Myogen Inc.NULLNot RecruitingFemale: yes
Male: yes
30Phase 2Belgium;Germany
54NCT00593905
(ClinicalTrials.gov)
July 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, College Park;University of California, San Francisco;University of Calgary;Chest Medical Associates;Columbia University;Lung Diagnostics, Ltd.;Duke University;University of California, Los Angeles;Latter Day Saints Hospital;Louisiana State University Health Sciences Center in New Orleans;Massachusetts General Hospital;Mayo Clinic;Medical College of Wisconsin;Southeastern Lung Care;Suncoast Lung Center;Children's Hospital Colorado;University Hospitals Cleveland Medical Center;University of Colorado, Denver;University of Michigan;University of Pittsburgh Medical Center;University of Southern California;The University of Texas Medical Branch, Galveston;Vanderbilt University;Wayne State University;Ohio State University;University of Alabama at Birmingham;Washington University School of Medicine;Sentara Norfolk General Hospital;University of Texas Southwestern Medical Center;Bay Area Chest PhysiciansWithdrawnN/AN/AAll0United States
55NCT00423592
(ClinicalTrials.gov)
May 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
56NCT00578786
(ClinicalTrials.gov)
February 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
57NCT00091598
(ClinicalTrials.gov)
January 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
58NCT00423748
(ClinicalTrials.gov)
December 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
59NCT00423202
(ClinicalTrials.gov)
December 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
60NCT00424021
(ClinicalTrials.gov)
April 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
61EUCTR2010-021572-29-FR
(EUCTR)
11/10/2011Testing 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: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: VOLIBRIS® (ambrisentan)
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Trade Name: VOLIBRIS® (ambrisentan)
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
66Phase 2United States;France;Hungary;Greece;Spain;Netherlands;Germany;Italy;Japan
62EUCTR2010-019547-19-Outside-EU/EEA
(EUCTR)
16/03/2012Testing 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: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: VOLIBRIS
Trade Name: VOLIBRIS™ tablets
Product Name: Ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: VOLIBRIS
Trade Name: VOLIBRIS™ tablets
Product Name: Ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: VOLIBRIS
GlaxoSmithKline Research & Development LimitedNULLNAFemale: yes
Male: yes
66Russian Federation;United States;Argentina;Brazil;Canada;Japan;Mexico