Sildenafil Citrate ( DrugBank: Sildenafil )


4 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1
85特発性間質性肺炎1
86肺動脈性肺高血圧症59
225先天性腎性尿崩症1

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01347008
(ClinicalTrials.gov)
April 20112/5/2011Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic SclerosisEffect of Sildenafil on the Microcirculatory Blood Flow and on the Endothelial Progenitor Cells in Patients With Systemic Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical TrialScleroderma, Systemic;Scleroderma, Diffuse;Scleroderma, Limited;Raynaud PhenomenonDrug: Sildenafil citrate;Drug: Placebo (Sugar pill)Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted18 YearsN/AFemale41Phase 3Brazil

85. 特発性間質性肺炎


臨床試験数 : 627 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00517933
(ClinicalTrials.gov)
August 200715/8/2007Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary FibrosisSildenafil Trial of Exercise Performance in Idiopathic Pulmonary FibrosisPulmonary Fibrosis;Hypertension, PulmonaryDrug: Sildenafil Citrate;Other: PlaceboDuke UniversityNational Heart, Lung, and Blood Institute (NHLBI);PfizerCompleted18 YearsN/AAll180Phase 3United States

86. 肺動脈性肺高血圧症


臨床試験数 : 1,205 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-004362-34-LV
(EUCTR)
03/10/201802/07/2018A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) 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: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
429Phase 3;Phase 4United States;Portugal;Serbia;Hong Kong;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Malaysia;Australia;South Africa;Latvia;Netherlands;Bosnia and Herzegovina;Turkey;Austria;Czech Republic;Mexico;Belgium;Poland;Singapore;Croatia;Romania;Germany;Sweden
2NCT03431649
(ClinicalTrials.gov)
April 1, 201729/7/2017Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in ChildrenEfficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart DefectPediatric Pulmonary HypertensionDrug: Beraprost Sodium;Drug: Sildenafil CitrateDr. Soetomo General HospitalNULLCompleted1 Year17 YearsAll40Phase 4Indonesia
3EUCTR2013-004362-34-HR
(EUCTR)
21/10/201526/05/2015A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) Pulmonary Arterial Hypertension
MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
429United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Netherlands;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
4EUCTR2013-004362-34-SE
(EUCTR)
26/08/201513/03/2014A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
429Phase 3;Phase 4United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
5EUCTR2013-004362-34-PT
(EUCTR)
08/05/201518/02/2015A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) 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: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
429Phase 3;Phase 4Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Spain;Thailand;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Czechia;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
6EUCTR2013-004362-34-NL
(EUCTR)
23/04/201529/01/2015A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) Pulmonary Arterial Hypertension
MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
429Phase 3;Phase 4Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
7EUCTR2013-004362-34-GR
(EUCTR)
21/11/201424/11/2014A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) Pulmonary Arterial Hypertension
MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Trade Name: Revatio
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
429Phase 4United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
8EUCTR2013-004362-34-PL
(EUCTR)
22/10/201417/07/2014A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) Pulmonary Arterial Hypertension
MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Trade Name: Revatio
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
429Phase 3;Phase 4United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
9EUCTR2013-004362-34-RO
(EUCTR)
25/09/201430/05/2014A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) Pulmonary Arterial Hypertension
MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Trade Name: Revatio
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
429Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
10NCT02060487
(ClinicalTrials.gov)
September 22, 201429/1/2014Effects of Oral Sildenafil on Mortality in Adults With PAHA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)Pulmonary Arterial HypertensionDrug: sildenafil citratePfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLTerminated18 Years74 YearsAll385Phase 4United States;Australia;Belgium;Bosnia and Herzegovina;Croatia;Czechia;Germany;Greece;Hong Kong;Israel;Latvia;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;Singapore;South Africa;Spain;Thailand;Turkey;Ukraine;Austria;Czech Republic;Netherlands;Portugal
11EUCTR2013-004362-34-CZ
(EUCTR)
08/09/201413/05/2014A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) 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: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
429Phase 3;Phase 4United States;Portugal;Serbia;Hong Kong;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Malaysia;Australia;South Africa;Latvia;Netherlands;Bosnia and Herzegovina;Turkey;Austria;Czech Republic;Mexico;Belgium;Poland;Singapore;Croatia;Romania;Germany;Sweden
12EUCTR2013-004362-34-DE
(EUCTR)
30/07/201425/03/2014A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) 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: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
429Phase 3;Phase 4United States;Portugal;Serbia;Hong Kong;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Malaysia;Australia;South Africa;Latvia;Netherlands;Bosnia and Herzegovina;Turkey;Austria;Czech Republic;Mexico;Belgium;Poland;Singapore;Croatia;Romania;Germany;Sweden
13EUCTR2013-004362-34-ES
(EUCTR)
30/06/201408/05/2014A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) Pulmonary Arterial Hypertension
MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Trade Name: Revatio
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
429Phase 4Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden;United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark
14EUCTR2013-004362-34-BE
(EUCTR)
12/06/201417/03/2014A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
429Phase 3United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
15EUCTR2013-004362-34-AT
(EUCTR)
12/05/201413/03/2014A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) Pulmonary Arterial Hypertension
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
429Phase 3;Phase 4United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
16EUCTR2011-002707-16-ES
(EUCTR)
09/01/201410/01/2014sildenafil in the postoperative period of cardiac surgery in children. SILDENAFIL IN THE POST-CARDIAC SURGERY IN CHILDREN: IVORY STUDY - IVORY Postoperative pulmonary artery hypertension
MedDRA version: 16.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;System Organ Class: 100000004855;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Trade Name: revatio oral
INN or Proposed INN: SILDENAFIL CITRATE
Other descriptive name: SILDENAFIL CITRATE
Trade Name: Revatio inyectable
INN or Proposed INN: SILDENAFIL CITRATE
Other descriptive name: SILDENAFIL CITRATE
Fundacion para la investigación Biomédica del hospital Gregorio MarañónNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain
17NCT01637675
(ClinicalTrials.gov)
May 20131/7/2012Efficacy and Safety Study of Sodium Tanshinone IIA Sulfonate on Pulmonary HypertensionClinical Study of Effects of Sodium Tanshinone IIA Sulfonate on Pulmonary HypertensionPulmonary Hypertension;Pulmonary Arterial Hypertension;Cardiovascular Diseases;Lung Diseases;Tanshinone IIA SulfonateDrug: 20 mg sildenafil citrate by mouth;Drug: sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouthThe First Affiliated Hospital of Guangzhou Medical UniversityJiangsu Carefree Pharmaceutical Co., LTD;The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School;Guangdong General Hospital;Sir run run shaw hospital Zhejiang University School of Medicine, Hangzhou, China;The First Affiliated Hospital of Zhengzhou University;Dongguan People's Hospital;Second Affiliated Hospital of Xi'an Jiaotong University;Beijing Chao Yang Hospital;Beijing Anzhen Hospital;Qingdao UniversityRecruiting15 Years70 YearsBoth90Phase 2/Phase 3China
18EUCTR2011-002018-35-IT
(EUCTR)
08/03/201330/10/2012SPHERIC-1OE: study of the duration of 12 months for the observation of the use of sildenafil for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease in patients enrolled in the previous study titled SPHERIC-1SPHERIC-1OE (Sildenafil and Pulmonary HypERtension In COPD – Open Extension) - A multicenter, longitudinal, 12 months open-label study, for the observation of the use of sildenafil in the treatment of patients with pulmonary hypertension associated to chronic obstructive lung disease enrolled in SPHERIC-1 study - SPHERIC-1 OPEN EXTENSION Patients with pulmonary hypertension associated with chronic obstructive pulmonary disease enrolled in the study SPHERIC-1
MedDRA version: 14.1;Level: LLT;Classification code 10010952;Term: COPD;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
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] - Respiratory Tract Diseases [C08]
INN or Proposed INN: SILDENAFIL CITRATEASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERINULLNot RecruitingFemale: yes
Male: yes
Italy
19NCT01517854
(ClinicalTrials.gov)
November 14, 201214/12/2011Revatio Portal-Pulmonary Arterial Hypertension TrialRevatio Portal-Pulmonary Arterial Hypertension Trial (RePo1 Trial): A Randomized, Double-blinded, Placebo-controlled, Multi-center Study to Evaluate the Effects of Sildenafil Citrate (Revatio) 20 mg TID on Patients With Portal Pulmonary Arterial Hypertension (PPAH)Portopulmonary HypertensionDrug: Sildenafil;Drug: PlaceboUniversity Health Network, TorontoNULLTerminated18 Years75 YearsAll12Phase 2Canada
20NCT01642407
(ClinicalTrials.gov)
August 24, 201215/6/2012Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial HypertensionA Phase 3, Multi-center, Open-label Study To Investigate Safety, Efficacy, And Tolerability Of Sildenafil Citrate In Pediatric Patients With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Hypertension, PulmonaryDrug: SildenafilPfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted1 Year17 YearsAll6Phase 4Japan
21NCT01582438
(ClinicalTrials.gov)
August 17, 201119/4/2012An Open Label Access Study For Subjects Who Completed A1481156A Local, Multicentre, Open Label Access Study, To Provide Sildenafil Therapy For Subjects Who Completed A1481156 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil For Subjects In IndiaPulmonary Arterial HypertensionDrug: Access program - sildenafil citrate, Viagra, RevatioPfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLNo longer available12 Years30 YearsAllIndia
22NCT01365585
(ClinicalTrials.gov)
July 20111/6/2011Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial HypertensionEvaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: sildenafil citratePfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted18 YearsN/AAll227Germany;Ireland
23NCT00796510
(ClinicalTrials.gov)
July 201020/11/2008Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term SafetyA Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Pulmonary HypertensionDrug: Sitaxsentan;Drug: Sitaxsentan and SildenafilPfizerNULLTerminated16 Years80 YearsAll3Phase 3United States;Romania;Ukraine;Argentina;Bulgaria;Chile;China;Colombia;Costa Rica;Czech Republic;Dominican Republic;India;Mexico;Peru;Philippines;Russian Federation;Saudi Arabia;Serbia;Slovakia;South Africa;Thailand
24EUCTR2008-005886-78-CZ
(EUCTR)
12/01/201010/12/2008A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONA PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION PULMONARY ARTERIAL HYPERTENSION
MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
25EUCTR2008-005887-14-CZ
(EUCTR)
12/01/201010/12/2008A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil Citrate
Pfizer Ltd.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
26EUCTR2008-005886-78-BG
(EUCTR)
25/06/200919/06/2009A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONA PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION PULMONARY ARTERIAL HYPERTENSION
MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
27EUCTR2008-005887-14-BG
(EUCTR)
25/06/200919/06/2009A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil Citrate
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
28ChiCTR-TCC-12002776
2009-05-012012-10-23BEraproST combined therapy with Sildenafil for pulmonary arterial hypertensionBEraproST combined therapy with Sildenafil for pulmonary arterial hypertension Pulmonary arterial hypertensionGroup B :beraprost combined with sildenafil ;A:Sildenafil citrate ;Shanghai Pulmonary HospitalNULLCompleted1865BothGroup B :30;A:30;China
29NCT00796666
(ClinicalTrials.gov)
May 200920/11/2008Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding SildenafilA Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001 (NCT00795639)Pulmonary Arterial Hypertension;Pulmonary HypertensionDrug: Sitaxsentan;Drug: Sitaxsentan and SildenafilPfizerNULLTerminated16 Years80 YearsAll131Phase 3United States;Argentina;Bulgaria;Chile;China;Colombia;Czech Republic;India;Malaysia;Mexico;Peru;Romania;Russian Federation;Serbia;South Africa;Thailand;Turkey;Ukraine;Costa Rica;Dominican Republic;Philippines;Saudi Arabia;Slovakia
30EUCTR2008-005886-78-SK
(EUCTR)
06/04/200920/02/2009A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONA PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION PULMONARY ARTERIAL HYPERTENSION
MedDRA version: 9.1;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Limited, Ramsgate Road, Sandwich, Kent UKNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Slovakia;Bulgaria
31EUCTR2008-005887-14-SK
(EUCTR)
01/04/200920/02/2009A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Thelin
INN or Proposed INN: Sitaxsentan Sodium
Trade Name: Revatio
INN or Proposed INN: Sildenafil Citrate
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Slovakia;Bulgaria
32NCT00878943
(ClinicalTrials.gov)
March 31, 20098/4/2009Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 StudyA Local, Multi-centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study In India Or Ongoing In A1481269 Study Who Continue To Receive Benefit From Sildenafil Therapy.Pulmonary Arterial HypertensionDrug: Sildenafil citratePfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLNo longer available18 YearsN/AAllIndia
33EUCTR2008-003572-21-BE
(EUCTR)
20/03/200908/09/2008A PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED,PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OFPF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHICAND FAMILIAL PULMONARY ARTERIAL HYPERTENSIONA PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED,PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OFPF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHICAND FAMILIAL PULMONARY ARTERIAL HYPERTENSION Pulmonary arterial hypertension.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: PF-00489791
Product Name: PF-00489791
Product Name: PF-00489791
Trade Name: Revatio
Product Name: REVATIO
INN or Proposed INN: Sildenafil Citrate
Pfizer Ltd,Ramsgate Road,Sandwich,Kent CT13 9NJNULLNot RecruitingFemale: yes
Male: yes
79Phase 2Germany;Belgium;Spain;Sweden
34EUCTR2006-006748-76-BG
(EUCTR)
30/01/200906/01/2009A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/AA MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A Pulmonary arterial hypertension (PAH)Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
219United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia
35EUCTR2006-006748-76-LV
(EUCTR)
22/10/200810/06/2008A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/AA MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A Pulmonary arterial hypertension (PAH)Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
219United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia
36EUCTR2006-006748-76-GB
(EUCTR)
15/10/200802/09/2008A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/AA MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A Pulmonary arterial hypertension (PAH)Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot Recruiting Female: yes
Male: yes
219 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesGreece;Belgium;Denmark;Bulgaria;Latvia;Netherlands;Italy;United Kingdom
37JPRN-UMIN000001350
2008/09/0101/10/2008Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseasesEarly intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases - Keio university clinical trial for early pulmonary arterial hypertension with connective tissue diseases (KEEP-ACTIVE study) Pulmonary arterial hypertension (PAH) associated with connective tissue diseaseBeraprost sodium
Beraprost sodium and Sildenafil citrate
Keio UniversityNULLComplete: follow-up complete18years-old80years-oldMale and Female70Not selectedJapan
38EUCTR2006-006748-76-GR
(EUCTR)
24/06/200814/03/2008A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/AA MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A Pulmonary arterial hypertension (PAH).
MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Revatio
INN or Proposed INN: sildenafil citrate
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil citrate
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil citrate
Other descriptive name: UK-92,480
Pfizer Ltd. Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
284United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia
39EUCTR2006-006748-76-BE
(EUCTR)
10/06/200829/01/2008A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/AA MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A Pulmonary arterial hypertension (PAH)INN or Proposed INN: Sildenafil citrate
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Ltd, Ramsgate Road, Sandwich, Kent UKNULLNot RecruitingFemale: yes
Male: yes
219United Kingdom;Netherlands;Denmark;Belgium;Bulgaria;Italy;Greece;Latvia
40EUCTR2006-006748-76-NL
(EUCTR)
23/04/200801/11/2007A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/AA MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A Pulmonary arterial hypertension (PAH).
MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Revatio
INN or Proposed INN: sildenafil citrate
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil citrate
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil citrate
Other descriptive name: UK-92,480
Pfizer Ltd. Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
284United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia
41NCT00430716
(ClinicalTrials.gov)
April 8, 200831/1/2007To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH)Pulmonary Arterial HypertensionDrug: Sildenafil citratePfizerNULLTerminated18 YearsN/AAll130Phase 4United States;Belgium;Brazil;Bulgaria;China;Greece;India;Italy;Latvia;Malaysia;Netherlands;Philippines;Poland;Romania;Russian Federation;Thailand;United Kingdom;Denmark;Panama
42EUCTR2006-006748-76-DK
(EUCTR)
21/01/200809/01/2008A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/AA MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5 MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A Pulmonary arterial hypertension (PAH)Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Trade Name: Revatio
INN or Proposed INN: Sildenafil citrate
Pfizer Ltd, Ramsgate Road, Sandwich, Kent UKNULLNot RecruitingFemale: yes
Male: yes
219Greece;Belgium;Denmark;Bulgaria;Latvia;Netherlands;United Kingdom;Italy
43NCT00454207
(ClinicalTrials.gov)
April 200728/3/2007Open Label Study of Sildenafil in Patients With Pulmonary Arterial HypertensionA Phase 3, Multi-Center, Open-Label Study to Assess Safety and Efficacy of Sildenafil Citrate 20 mg TID in Subjects With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: sildenafil citrate (UK-92,480)PfizerNULLCompleted16 YearsN/AAll44Phase 3Japan
44EUCTR2006-002235-25-FI
(EUCTR)
28/03/200709/01/2007A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/AA Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A Pulmonary Arterial Hypertension
MedDRA version: 9.0;Level: LLT;Classification code 10064911
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Product Name: Sildenafil Citrate
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United KingdomNULLNot RecruitingFemale: yes
Male: yes
204Finland;United Kingdom
45EUCTR2006-002235-25-SK
(EUCTR)
22/03/200713/02/2007A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/AA Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A Pulmonary Arterial Hypertension
MedDRA version: 9.0;Level: LLT;Classification code 10064911
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Product Name: Sildenafil Citrate
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United KingdomNULLNot RecruitingFemale: yes
Male: yes
204Phase 3Slovakia;Finland;United Kingdom
46EUCTR2006-002235-25-GB
(EUCTR)
14/12/200618/09/2006A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/AA Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A Pulmonary Arterial Hypertension
MedDRA version: 9.0;Level: LLT;Classification code 10064911
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Product Name: Sildenafil Citrate
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United KingdomNULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSlovakia;Finland;United Kingdom
47NCT00323297
(ClinicalTrials.gov)
September 20065/5/2006Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial HypertensionA Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah)Pulmonary Arterial HypertensionDrug: Bosentan;Other: Placebo;Drug: Sildenafil CitratePfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted18 YearsN/AAll105Phase 4United States;Australia;Czechia;France;Germany;Greece;Israel;Italy;Taiwan;United Kingdom;Belgium;Czech Republic
48EUCTR2005-005066-37-DE
(EUCTR)
09/06/200606/11/2006COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxinsPatients are already on prescribed bosentan therapy for at least 12 weeks.Product Name: sildenafil
Product Code: N/A
INN or Proposed INN: Sildenafil citrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
44Phase 2United Kingdom;Germany;Italy
49EUCTR2005-005066-37-BE
(EUCTR)
21/04/200615/02/2006COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxinsPatients are already on prescribed bosentan therapy for at least 12 weeks.Trade Name: viagra
Product Name: sildenafil
Product Code: N/A
INN or Proposed INN: Sildenafil citrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
44Phase 2Belgium;Germany;Italy;United Kingdom
50EUCTR2005-005066-37-GB
(EUCTR)
15/03/200613/02/2006COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxins Patients are already on prescribed bosentan therapy for at least 12 weeks.Trade Name: viagra
Product Name: sildenafil
Product Code: N/A
INN or Proposed INN: Sildenafil citrate
Actelion Pharmaceuticals Ltd.NULLNot Recruiting Female: yes
Male: yes
44 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelgium;Germany;Italy;United Kingdom
51NCT00159874
(ClinicalTrials.gov)
January 20048/9/2005A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In ChildrenA Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil Citrate In The Treatment Of Subjects Who Have Completed Study A1481131Pulmonary Arterial HypertensionDrug: Sildenafil citratePfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted1 Year17 YearsAll234Phase 3United States;Brazil;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;Sweden;Taiwan;Canada;Costa Rica;Panama;Singapore
52NCT00159913
(ClinicalTrials.gov)
August 20038/9/2005A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension.Pulmonary Arterial Hypertension, ChildrenDrug: Sildenafil citrate;Drug: PlaceboPfizerNULLCompleted1 Year17 YearsAll235Phase 3United States;Brazil;Canada;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Peru;Poland;Russian Federation;Sweden;Taiwan;Australia;Costa Rica;Panama;Singapore
53NCT00159861
(ClinicalTrials.gov)
July 20038/9/2005The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAHA Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension.Pulmonary HypertensionDrug: Sildenafil citratePfizer's Upjohn has merged with Mylan to form Viatris Inc.PfizerCompleted16 YearsN/AAll267Phase 3United States;Belgium;Canada;Czechia;Denmark;France;Israel;Italy;Netherlands;Spain;United Kingdom;Czech Republic
54NCT00159887
(ClinicalTrials.gov)
December 20028/9/2005Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial HypertensionA Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140.Pulmonary HypertensionDrug: Sildenafil citratePfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted18 YearsN/AAll260Phase 3United States;Australia;Belgium;Brazil;Czechia;Denmark;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Poland;Singapore;South Africa;Spain;Sweden;United Kingdom;Czech Republic
55EUCTR2005-000963-25-Outside-EU/EEA
(EUCTR)
07/03/2012Oral Revatio in Pediatric PAH - Long-term follow-on Study to A1481131.A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Sildenafil Citrate
Product Code: UK-92,480-10
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Product Name: Sildenafil Citrate
Product Code: UK-92,480-10
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Product Name: Sildenafil Citrate
Product Code: UK-92,480-10
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UKNULLNAFemale: yes
Male: yes
220Russian Federation;Taiwan;United States;Brazil;Chile;Colombia;Guatemala;India;Japan;Malaysia;Mexico
56EUCTR2014-004167-20-Outside-EU/EEA
(EUCTR)
24/03/2015Open Label Study of Sildenafil in Subjects With Pulmonary Arterial HypertensionA Phase 3, Multi-Center, Open-Label Study To Confirm Safety, Efficacy And Tolerability Of Sildenafil Citrate 20 Mg Three Times a Day (TID) In Subjects With Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension
MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 17.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;System Organ Class: 100000004855;Therapeutic area: Not possible to specify
Trade Name: Revatio
Product Name: SILDENAFIL CITRATE
INN or Proposed INN: SILDENAFIL CITRATE
Other descriptive name: SILDENAFIL CITRATE
Trade Name: Revatio
Product Name: SILDENAFIL CITRATE
INN or Proposed INN: SILDENAFIL CITRATE
Other descriptive name: SILDENAFIL CITRATE
Pfizer Japan IncNULLNAFemale: yes
Male: yes
44Phase 3Japan
57EUCTR2006-002235-25-Outside-EU/EEA
(EUCTR)
07/03/2012A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial HypertensionA Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Sildenafil Citrate
Product Code: UK-92,480-10
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Product Name: Sildenafil Citrate
Product Code: UK-92,480-10
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United KingdomNULLNAFemale: yes
Male: yes
235Brazil;Canada;Chile;Colombia;Guatemala;India;Japan;Malaysia;Mexico;Peru;Russian Federation;Taiwan;United States
58EUCTR2015-002238-37-Outside-EU/EEA
(EUCTR)
16/06/2015An Open Label Access Study For Subjects Who Completed A1481156A Local, Multicentre, Open Label Access Study, To Provide Sildenafil Therapy For Subjects Who Completed A1481156 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil For Subjects In India Pulmonary Arterial Hypertension
MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Trade Name: Revatio
Product Name: Revatio
Product Code: UK-92,480
INN or Proposed INN: Sildenafil citrate
Other descriptive name: SILDENAFIL CITRATE
Pfizer, Ltd.NULLNAFemale: yes
Male: yes
4India
59EUCTR2016-003978-41-Outside-EU/EEA
(EUCTR)
13/10/2016Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial HypertensionA Phase 3, Multi-center, Open label Study To Investigate Safety, Efficacy, And Tolerability Of Sildenafil Citrate In Pediatric Patients With Pulmonary Arterial Hypertension Pulmonary arterial hypertension
MedDRA version: 19.0;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: Revatio 10 mg/ml powder for oral suspension
Product Name: Revatio POS
Product Code: G04BE03
INN or Proposed INN: 171
Other descriptive name: SILDENAFIL CITRATE
Trade Name: Revatio 20 mg film coated tablets
Product Name: Revatio Tablets
Product Code: G04BE03
INN or Proposed INN: 171
Other descriptive name: SILDENAFIL CITRATE
Pfizer, Inc.NULLNAFemale: yes
Male: yes
6Phase 3Japan

225. 先天性腎性尿崩症


臨床試験数 : 15 薬物数 : 48 - (DrugBank : 18) / 標的遺伝子数 : 31 - 標的パスウェイ数 : 65
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2006-003360-56-DK
(EUCTR)
28/08/200907/07/2009Farmakologisk behandling af CNDI – Et ”proof-of-concept” studie. - NDI-POC-STUDYFarmakologisk behandling af CNDI – Et ”proof-of-concept” studie. - NDI-POC-STUDY Kongenit nefrogen diabetes insipidus
MedDRA version: 14.1;Level: PT;Classification code 10068304;Term: Congenital nephrogenic diabetes insipidus;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: Confortid
INN or Proposed INN: INDOMETACIN
Trade Name: Losec
INN or Proposed INN: OMEPRAZOLE MAGNESIUM
Trade Name: Viagra
Other descriptive name: SILDENAFIL CITRATE
Trade Name: Miacalcic
Other descriptive name: CALCITONIN (SALMON)
Trade Name: Spirix
Other descriptive name: SPIRONOLACTONE
Trade Name: Esidrix
Product Name: Esidrix
INN or Proposed INN: HYDROCHLOROTHIAZIDE
Dept. of Pediatrics, The Childrens Hospital, DenverNULLNot RecruitingFemale: no
Male: yes
40Denmark