86. 肺動脈性肺高血圧症 [臨床試験数:1,083,薬物数:667(DrugBank:122),標的遺伝子数:98,標的パスウェイ数:185

Searched query = "Pulmonary arterial hypertension", "PAH", "IPAH", "HPAH", "Eisenmenger syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
46 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03364244November 30, 201730/11/2017Revavtio Special Investigation for Long-term Use in Pediatric PatientsREVATIO SPECIAL INVESTIGATION - INVESTIGATION FOR LONG-TERM USE OF REVATIO IN PEDIATRIC PATIENTS -Pulmonary Arterial HypertensionDrug: SildenafilPfizerNULLRecruitingN/A14 YearsAll190Japan
2EUCTR2016-001067-36-CZ19/01/201713/10/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 19.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Revatio
Product Name: Revatio 20 mg film-coated tablets
INN or Proposed INN: SILDENAF
Bayer AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
218Phase 4Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
3EUCTR2016-001067-36-ES21/11/201609/09/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 19.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Revatio
Product Name: Revatio 20 mg film-coated tablets
INN or Proposed INN: SILDENAF
Bayer AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
218Phase 4United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
4EUCTR2016-001067-36-AT10/11/201620/09/2016A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with RiociguatA prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy Pulmonary Arterial Hypertension (PAH)
MedDRA version: 19.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: Adempas® 0.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 1.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.0 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas® 2.5 mg film-coated tablets
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adcirca
Product Name: ADCIRCA 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
Trade Name: Revatio
Product Name: Revatio 20 mg film-coated tablets
INN or Proposed INN: SILDENAF
Bayer AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
218Phase 4Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
5EUCTR2013-004362-34-GR21/11/201424/11/2014A 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: 17.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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 4Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2013-004362-34-PL22/10/201417/07/2014A 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: 17.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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 4Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
7EUCTR2013-004362-34-RO25/09/201430/05/2014A 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: 17.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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
8EUCTR2013-004362-34-ES30/06/201408/05/2014A 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: 17.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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
9EUCTR2011-002707-16-ES09/01/201410/01/2014sildenafil 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: 16.1Level: LLTClassification code 10065150Term: Associated with pulmonary arterial hypertensionSystem 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
10NCT01517854November 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT01582438November 201219/4/2012An 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, RevatioPfizerNULLNo longer available12 Years30 YearsAllN/AIndia
12EUCTR2010-021344-17-IT28/01/201107/02/2011A non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - NDA non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - ND Pulmonary arterial hypertension (PAH)
MedDRA version: 9.1Level: LLTClassification code 10064911
Trade Name: GLIVEC
INN or Proposed INN: IMATINIB MESYLATE
Trade Name: REVATIO
INN or Proposed INN: Sildenafil
Trade Name: TRACLEER
INN or Proposed INN: Bosentan
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
24Italy
13EUCTR2008-005887-14-CZ12/01/201010/12/2008A 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: 9.1Level: LLTClassification code 10064911Term: 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
14EUCTR2008-005886-78-CZ12/01/201010/12/2008A 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: 9.1Level: HLTClassification code 10037401Term: 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
15EUCTR2008-003572-21-SE19/11/200925/08/2008A 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: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Product Name: PF-00489791
Product Name: PF-00489791
Product Name: PF-00489791
Trade Name: Revatio
Pfizer Ltd,Ramsgate Road,Sandwich,Kent CT13 9NJNULLNot RecruitingFemale: yes
Male: yes
79Phase 2Germany;Belgium;Spain;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2008-005887-14-BG25/06/200919/06/2009A 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: 9.1Level: LLTClassification code 10064911Term: 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
17EUCTR2008-005886-78-BG25/06/200919/06/2009A 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: 9.1Level: HLTClassification code 10037401Term: 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
18EUCTR2008-005886-78-SK06/04/200920/02/2009A 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: 9.1Level: HLTClassification code 10037401Term: 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
19EUCTR2008-005887-14-SK01/04/200920/02/2009A 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: 9.1Level: LLTClassification code 10064911Term: 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
20EUCTR2008-003572-21-BE20/03/200908/09/2008A 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: 9.1Level: LLTClassification code 10064911Term: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2006-006748-76-BG30/01/200906/01/2009A 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
22EUCTR2008-003572-21-DE30/01/200924/09/2008A PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OF PF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHIC AND FAMILIAL PULMONARY ARTERIAL HYPERTENSIONA PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OF PF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHIC AND FAMILIAL PULMONARY ARTERIAL HYPERTENSION Pulmonary arterial hypertension.
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Product Name: PF-00489791
Product Name: PF-00489791
Product Name: PF-00489791
Trade Name: Revatio 20 mg Filmtabletten
Product Name: Sildenafil Filmtabletten
INN or Proposed INN: Sildenafil
Pfizer Ltd.NULLNot RecruitingFemale: yes
Male: yes
79Phase 2Spain;Belgium;Germany;Sweden
23EUCTR2008-003572-21-ES15/01/200915/10/2008Estudio en fase 2a, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para investigar la respuesta a la dosis de PF-00489791 sobre la hemodinamia a corto plazo en sujetos con hipertensión arterial pulmonar idiopática y familiarA 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 HYPERTENSIONEstudio en fase 2a, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para investigar la respuesta a la dosis de PF-00489791 sobre la hemodinamia a corto plazo en sujetos con hipertensión arterial pulmonar idiopática y familiarA 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 Hipertensión arterial pulmonarPulmonary arterial hypertension.
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Product Name: PF-00489791
Product Name: PF-00489791
Product Name: PF-00489791
Trade Name: REVATIO 20 mg, comprimidos recubiertos con película
INN or Proposed INN: SILDENAFILO
Other descriptive name: SILDENAFIL
Pfizer, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
79Phase 2Germany;Belgium;Spain;Sweden
24EUCTR2006-001464-23-GR04/11/200830/01/2009A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/AA multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A Pulmonary Arterial Hypertension
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Trade Name: Revatio
Product Name: Revatio®
Product Code: UK-92,480
INN or Proposed INN: Sildenafil
Pfizer Ltd,Ramsgate Road,Sandwich CT13 9NJNULLNot RecruitingFemale: yes
Male: yes
106Czech Republic;Greece;Germany;Italy;United Kingdom
25EUCTR2006-006748-76-LV22/10/200810/06/2008A 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2006-006748-76-GR24/06/200814/03/2008A 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: 8.1Level: LLTClassification code 10037400Term: 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
27EUCTR2006-006748-76-BE10/06/200829/01/2008A 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
28EUCTR2006-006748-76-NL23/04/200801/11/2007A 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: 8.1Level: LLTClassification code 10037400Term: 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
29EUCTR2006-006748-76-IT21/04/200821/02/2008A 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) - NDA 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) - ND Pulmonary arterial hypertension (PAH).
MedDRA version: 9.1Level: LLTClassification code 10037400Term: Pulmonary hypertension
Trade Name: Revatio
INN or Proposed INN: Sildenafil
Trade Name: Revatio
INN or Proposed INN: Sildenafil
Trade Name: Revatio
INN or Proposed INN: Sildenafil
PFIZERNULLNot RecruitingFemale: yes
Male: yes
284United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia
30EUCTR2006-006748-76-DK21/01/200809/01/2008A 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2007-002774-64-DE04/12/200720/08/2007Therapy of PAH – Treatment with Sildenafil in Eisenmenger Patients - SildenafilTherapy of PAH – Treatment with Sildenafil in Eisenmenger Patients - Sildenafil Patients with pre-existing congenital heart disease may develop Eisenmenger physiology (EP), characterized by development of pulmonary arterial hypertension and intracardiac right to left shunt. This Patients suffer from cyanosis and reduced quality of life. While EP has been regarded as not amenable to conventional treatments, new oral drugs as Sildenafil have been used successfully to improve primary arterial hypertension. Thus may be an important treatment option for patients with EP, too.Trade Name: Revatio
INN or Proposed INN: SILDENAFIL
Deutsches Herzzentrum Berlin, Kompetenznetz Angeborene HerzfehlerNULLNot RecruitingFemale: yes
Male: yes
80Germany
32EUCTR2006-004705-26-GB10/05/200717/04/2007Safety and Tolerability of Sildenafil in Patients with Eisenmenger PhysiologySafety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology Eisenmenger Syndrome (pulmonary hypertension due to congenital heart disease)
MedDRA version: 8.1Level: LLTClassification code 10058554Term: Eisenmenger's syndrome
Trade Name: Revatio ® 20 mg film-coated tablets
Product Name: Sildenafil
INN or Proposed INN: Sildenafil (REVATIO)
Imperial College LondonNULLNot RecruitingFemale: yes
Male: yes
12Phase 4United Kingdom
33EUCTR2005-000963-25-SK20/04/200720/03/2007A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/AA 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: 8.1Level: LLTClassification 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
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
185Phase 3Slovakia;Finland;United Kingdom;Sweden
34EUCTR2005-000963-25-FI28/03/200709/01/2007A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/AA 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: 8.1Level: LLTClassification 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
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
185Finland;United Kingdom;Sweden
35EUCTR2006-002235-25-FI28/03/200709/01/2007A 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: 9.0Level: LLTClassification 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2006-002235-25-SK22/03/200713/02/2007A 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: 9.0Level: LLTClassification 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
37EUCTR2005-000963-25-GB13/09/200619/09/2006A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/AA 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: 8.1Level: LLTClassification 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
INN or Proposed INN: sildenafil (as citrate)
Other descriptive name: UK-92,480
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Slovakia;Finland;United Kingdom;Sweden
38EUCTR2006-001464-23-DE04/07/200605/05/2006A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg three times daily or placebo when added to bosentan in the treatment of adult subjects, withpulmonary arterial hypertension.A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A Pulmonary Arterial Hypertension
MedDRA version: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Trade Name: Revatio
Product Name: Revatio®
Product Code: UK-92,480
INN or Proposed INN: Sildenafil
Other descriptive name: n/a
Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
106France;Czech Republic;Taiwan;Greece;Belgium;Australia;Israel;Germany;Italy;United Kingdom
39EUCTR2006-001464-23-CZ08/06/200621/04/2006A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/AA multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A Pulmonary Arterial Hypertension
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Trade Name: Revatio
Product Name: Revatio®
Product Code: UK-92,480
INN or Proposed INN: Sildenafil
Pfizer Ltd,Ramsgate Road,Sandwich CT13 9NJNULLNot RecruitingFemale: yes
Male: yes
106Czech Republic;Greece;Germany;Italy;United Kingdom
40EUCTR2005-000963-25-SE30/05/200506/04/2005Oral Revatio in Pediatric PAH- Long term follow on study to A1481131A 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: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
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
Pfizer Limited, Ramsgate Road, Sandwich, Kent, UKNULLNot RecruitingFemale: yes
Male: yes
200Taiwan;Finland;Thailand;Costa Rica;Guatemala;Chile;Russian Federation;Colombia;United Kingdom;Italy;India;Hungary;Mexico;Brazil;Malaysia;Poland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2016-003978-41-Outside-EU/EEA13/10/2016Safety 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: 19.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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
42EUCTR2015-002238-37-Outside-EU/EEA16/06/2015An 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: 18.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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
43EUCTR2014-004167-20-Outside-EU/EEA24/03/2015Open 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: 17.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 17.1Level: LLTClassification code 10065151Term: Idiopathic pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 17.1Level: LLTClassification code 10065152Term: Familial pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 17.1Level: LLTClassification code 10065150Term: Associated with pulmonary arterial hypertensionSystem 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
44EUCTR2006-002235-25-Outside-EU/EEA07/03/2012A 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: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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
45EUCTR2005-005068-97-DE13/02/2006Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins
MedDRA version: 9.1Level: LLTClassification code 10064908Term: Associated with (APAH)
MedDRA version: 9.1Level: LLTClassification code 10064909Term: Idiopathic (IPAH)
MedDRA version: 9.1Level: LLTClassification code 10064910Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
Trade Name: Viagra
INN or Proposed INN: sildenafil (as citrate)
Trade Name: Viagra
INN or Proposed INN: sildenafil (as citrate)
Trade Name: Viagra
INN or Proposed INN: sildenafil
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
46EUCTR2005-000963-25-Outside-EU/EEA07/03/2012Oral 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: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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