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


臨床試験数 : 1,181 薬物数 : 701 - (DrugBank : 126) / 標的遺伝子数 : 105 - 標的パスウェイ数 : 192

  
134 trials found
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PhaseCountries
1NCT04039464
(ClinicalTrials.gov)
April 1, 20221/7/2019Mono vs. Dual Therapy for Pediatric Pulmonary Arterial HypertensionKids MoD PAH Trial: Mono- vs. Duo-Therapy for Pediatric Pulmonary Arterial HypertensionPediatric Pulmonary HypertensionDrug: Mono-Therapy with Sildenafil;Drug: Duo-Therapy with Sildenafil + BosentanJohns Hopkins UniversityNULLNot yet recruiting4 Months18 YearsAll100Phase 3United States
2EUCTR2013-004362-34-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
3NCT04994860
(ClinicalTrials.gov)
March 22, 201829/7/2021Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of SildenafilAn Open-Label, Three Period, Fixed Sequence Study to Assess the Effect of a Single Dose of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Sildenafil in Healthy Subjects Under Fasting ConditionsPulmonary Arterial HypertensionDrug: BIA 5-1058;Drug: SildenafilBial - Portela C S.A.NULLCompleted18 Years45 YearsAll20Phase 1Germany
4NCT03364244
(ClinicalTrials.gov)
November 30, 201730/11/2017Revatio 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
5NCT03431649
(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
6NCT02891850
(ClinicalTrials.gov)
January 11, 201726/8/2016Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapyA 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 GoalPulmonary Arterial HypertensionDrug: Adempas (Riociguat, BAY63-2521);Drug: Sildenafil;Drug: TadalafilBayerNULLCompleted18 Years75 YearsAll225Phase 4United States;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Spain;Taiwan;Turkey;United Kingdom;Australia;Switzerland
7NCT03053739
(ClinicalTrials.gov)
December 201629/12/2016To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisRandomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisAssociated Pulmonary Arterial HypertensionDrug: Sildenafil 20mg and Bosentan 62.5mg;Drug: Sildenafil 20mg and PlaceboPostgraduate Institute of Medical Education and ResearchNULLRecruiting18 YearsN/AAll50Phase 4India
8EUCTR2013-004362-34-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
9EUCTR2013-004362-34-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
10EUCTR2013-004362-34-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
11EUCTR2013-004362-34-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
12NCT02284737
(ClinicalTrials.gov)
November 28, 201428/10/2014A Study to Investigate the Efficacy of PADN to Improved Functional Capacity and Hemodynamics in Patients With PAHA Prospective, Multi-center, Randomized Control Trial to Investigate the Efficacy of Pulmonary Artery Denervation to Improved Functional Capacity and Hemodynamics in Patients With Pulmonary Artery HypertensionPulmonary Arterial HypertensionProcedure: PADN;Procedure: sham PADN;Drug: SildenafilNanjing First Hospital, Nanjing Medical UniversityNULLTerminated18 YearsN/AAll100Phase 4China
13EUCTR2013-004362-34-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
14EUCTR2013-004362-34-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
15EUCTR2013-004362-34-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
16NCT02060487
(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 citratePfizerNULLCompleted18 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
17EUCTR2013-004362-34-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
18EUCTR2013-004362-34-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
19ChiCTR-TRC-14004894
2014-07-012014-06-30Clinical research on treatment of pulmonary arterial hypertension associated with connective tissue disease by Mycophenolate mofetilClinical research on treatment of pulmonary arterial hypertension associated with connective tissue pulmonary arterial hypertension associated with connective tissue diseaseA:Glucocorticoid plus sildenafil;B:Glucocorticoid plus sildenafil;Beijing Chaoyang Hospital affiliated to Capital Medical UniversityNULLRecruiting1880MaleA:8;B:8;NULL
20EUCTR2013-004362-34-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
21EUCTR2013-004362-34-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
22EUCTR2013-004362-34-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
23EUCTR2011-002707-16-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
24NCT01897740
(ClinicalTrials.gov)
July 20138/7/2013Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With SildenafilA LOCAL, SINGLE-CENTRE, EXTENSION, 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, PRIOR TO REIMBURSEMENT AND AVAILABILITY FOR SUBJECTS IN RUSSIAN FEDERATIONPulmonary Arterial HypertensionDrug: sildenafilPfizerNULLNo longer available10 Years30 YearsAllRussian Federation
25NCT01637675
(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
26NCT03236818
(ClinicalTrials.gov)
May 201318/3/2013Goal Oriented Strategy to Preserve Ejection Fraction TrialRaising the Bars in the Treatment of Pulmonary Arterial Hypertension: Goal Oriented Strategy to Preserve Ejection Fraction TrialPulmonary Arterial HypertensionDrug: ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan)VU University Medical CenterNULLActive, not recruiting18 Years80 YearsAll30Phase 4Netherlands
27EUCTR2011-002018-35-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
28NCT01517854
(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
29NCT01642407
(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
30NCT01548950
(ClinicalTrials.gov)
September 20115/3/2012Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary HypertensionCombined Clinical and Surgical Approaches to Congenital Heart Disease Associated With Pulmonary Arterial Hypertension (PAH-CHD)Congenital Heart Disease;Pulmonary Arterial HypertensionDrug: Sildenafil singly or in association with BosentanUniversity of Sao Paulo General HospitalInstituto do Coracao;Fundação de Amparo à Pesquisa do Estado de São PauloCompleted2 MonthsN/AAll50N/ABrazil
31NCT01582438
(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
32EUCTR2010-018863-40-ES
(EUCTR)
29/07/201120/06/2011Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parametersAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension
MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 0.5 mg
Product Code: BAY 63-2521
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
36Czech Republic;Poland;Spain;Austria;Germany;United Kingdom;Italy
33NCT01365585
(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
34NCT01409122
(ClinicalTrials.gov)
July 20111/8/2011Safety, Tolerability, and PK Parameters of Sodium Nitrite Inhalation Solution in Healthy SubjectsA Phase 1, Placebo Controlled, Blinded, Multiple Dose Escalation Study of AIR001 (Sodium Nitrite Inhalation Solution) in Healthy Subjects, an Assessment of the Tolerability in Combination With Oral Sildenafil, and an Open-Label Study of Multiple Dose AIR001 in Patients With Pulmonary Arterial HypertensionPulmonary Hypertension;Pulmonary Arterial HypertensionDrug: 15 mg sodium nitrite inhalation solution;Drug: 90 mg sodium nitrite inhalation solution;Drug: 45 mg sodium nitrite inhalation solution;Drug: 120 mg sodium nitrite inhalation solution;Drug: 25% MTD sodium nitrite inhalation solutionAires Pharmaceuticals, Inc.NULLCompleted18 Years56 YearsBoth42Phase 1United States
35EUCTR2010-018863-40-GB
(EUCTR)
24/06/201124/03/2011Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parametersAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS 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: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
18 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Spain;Poland;Austria;Germany;Italy;United Kingdom
36NCT01392469
(ClinicalTrials.gov)
April 20, 201110/5/2011Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension ParticipantsA 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) PatientsPulmonary Arterial HypertensionDrug: Imatinib;Drug: Sildenafil;Drug: BosentanNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll21Phase 3United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Romania;Turkey
37JPRN-UMIN000005464
2011/04/0119/04/2011Drug interactions and effects of combination therapy for pulmonary arterial hypertension pulmonary arterial hypertensionphase 1: sildenafil (60mg/day) and bosentan (250mg/day) for 4 or 5 weeks
phase 2: sildenafil(60mg/day) and
ambrisentan (5mg/day) for 4 or 5 weeks
phase 3: tadalafil (40mg/day) and ambrisentan (5mg/day) for 4 or 5 weeks
Hamamatsu University School of MedicineUniversity of ShizuokaRecruiting20years-oldNot applicableMale and Female15Not applicableJapan
38EUCTR2010-021344-17-IT
(EUCTR)
28/01/201107/02/2011A 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: 9.1;Level: LLT;Classification 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
39EUCTR2010-018863-40-PL
(EUCTR)
25/01/201107/06/2010Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parametersAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension
MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
36Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy
40EUCTR2010-018863-40-AT
(EUCTR)
05/01/201120/07/2010An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUSAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: BAY 63-2521 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Bayer Health Care AGNULLNot RecruitingFemale: yes
Male: yes
36United Kingdom;Czech Republic;Germany;Spain;Italy;Poland;Austria
41NCT01244620
(ClinicalTrials.gov)
November 201015/11/2010A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple DosesA Phase 1, Open Label, Randomized, Four Period, Crossover, Multiple Dose Study To Assess The Pharmacokinetic Interaction Between Sitaxsentan and Tadalafil and The Effect Of Sildenafil On Sitaxsentan PK In Healthy SubjectsPulmonary Arterial HypertensionDrug: sitaxentan;Drug: tadalafil;Drug: sitaxsentan;Drug: sildenafilPfizerNULLTerminated21 Years55 YearsAll16Phase 1Singapore
42JPRN-UMIN000012669
2010/10/0101/10/2015Efficacy and safety of sildenafil in the treatment of pulmonary arterial hypertension (PAH) after cardiac surgery in Japanese pediatric population - a PAH management- pulmonary hypertensionSildenafil will be administered via a nasogastric tube or orally at a dose of 0.5 mg/kg. If the investigator note there is no effect of sildenafil on any parameters and clinical conditions, a repeat dose of sildenafil (0.5 or 1.0 mg/kg) can be given 4 hours after the initial administration by the investigators judgment. Sildenafil will be gradually weaned off for 5 to 7 days.Osaka Medical CollegeNULLComplete: follow-up completeNot applicable24months-oldMale and Female20Not applicableJapan
43NCT01179334
(ClinicalTrials.gov)
August 201010/8/2010Evaluation of the Pharmacodynamic Effect of the Combination of Sildenafil and Riociguat on Blood Pressure and Other Safety Parameters.An Interaction Study to Evaluate Changes in Blood Pressure Following 1, 1.5, 2, and 2.5 mg Riociguat Tid (Dose Titration) Compared to Placebo Treatment on the Background of Stable Sildenafil Pretreatment in Subjects With Symptomatic Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Riociguat (Adempas, BAY63-2521);Drug: Placebo;Drug: SildenafilBayerNULLCompleted18 Years75 YearsAll18Phase 2United States;Austria;Czech Republic;Germany;Italy;New Zealand;Poland;Spain;United Kingdom
44EUCTR2010-018863-40-CZ
(EUCTR)
22/07/201002/06/2010Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parametersAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS 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: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 0.5 mg
Product Code: BAY 63-2521
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
36Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy
45EUCTR2010-018863-40-IT
(EUCTR)
20/07/201020/08/2010An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUSAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension.
MedDRA version: 9.1;Level: LLT;Classification code 10064911
Product Name: Riociguat
Product Name: Riociguat
Product Name: Riociguat
Product Name: Riociguat
Bayer Health Care AGNULLNot RecruitingFemale: yes
Male: yes
36Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy
46EUCTR2010-018863-40-DE
(EUCTR)
16/07/201026/04/2010Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parametersAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS 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: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR tablets 0.5 mg
Product Code: BAY 63-2521
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
18Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy
47NCT00796510
(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
48EUCTR2010-020917-97-IT
(EUCTR)
23/06/201028/12/2011SPHERIC-1 (Sildenafil in the Chronic Obstructive Pulmonary Disease associated to Chronic Pulmonary Hypertension. Sixteen weeks long, multicentre, randomized, double blind study, in comparison with placebo, for the evaluation of sildenafil in the treatment of patients affected by pulmonary hypertension associated to COPD. - SPHERIC-1SPHERIC-1 (Sildenafil in the Chronic Obstructive Pulmonary Disease associated to Chronic Pulmonary Hypertension. Sixteen weeks long, multicentre, randomized, double blind study, in comparison with placebo, for the evaluation of sildenafil in the treatment of patients affected by pulmonary hypertension associated to COPD. - SPHERIC-1 Moderate to severe pulmonary hypertension associated to moderate to mild COPD.
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Level: LLT;Classification code 10010952;Term: COPD;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
INN or Proposed INN: SildenafilASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERINULLNot RecruitingFemale: yes
Male: yes
Italy
49EUCTR2008-005887-14-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
50EUCTR2008-005886-78-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
51EUCTR2005-005068-97-BE
(EUCTR)
29/10/200910/06/2009Effects 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: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;Czech Republic;Greece;Spain;Belgium;Denmark;Germany;United Kingdom;Sweden
52EUCTR2008-005886-78-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
53EUCTR2008-005887-14-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
54EUCTR2005-005068-97-CZ
(EUCTR)
16/06/200911/06/2009Effects 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: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
55ChiCTR-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
56NCT00796666
(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
57EUCTR2008-005886-78-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
58EUCTR2008-005887-14-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
59NCT00853112
(ClinicalTrials.gov)
April 200927/2/2009A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With 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 HypertensionHypertension, PulmonaryDrug: PF-00489791;Drug: placebo;Drug: sildenafilPfizerNULLTerminated18 YearsN/AAll48Phase 2United States;Canada;Germany;India;Russian Federation;Spain;Sweden;Switzerland;Belgium
60NCT01391104
(ClinicalTrials.gov)
April 20097/7/2011Responsiveness of Exercise Tests in Pulmonary Arterial HypertensionReproducibility and Responsiveness of Exercise Tests in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Sildenafil;Drug: Sugar PillLaval UniversityNULLCompleted18 Years80 YearsBoth22N/ACanada
61NCT00878943
(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
62EUCTR2008-003572-21-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
63EUCTR2008-003572-21-DE
(EUCTR)
30/01/200924/09/2008A 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: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: PF-00489791
Product Name: PF-00489791
Product Name: PF-00489791
Trade Name: Revatio 20 mg Filmtabletten
Product Name: Sildenafil Filmtabletten
INN or Proposed INN: Sildenafil
Pfizer Ltd.NULLNot RecruitingFemale: yes
Male: yes
79Phase 2Spain;Belgium;Germany;Sweden
64EUCTR2006-006748-76-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
65EUCTR2008-003572-21-ES
(EUCTR)
15/01/200915/10/2008Estudio 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: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: PF-00489791
Product Name: PF-00489791
Product Name: PF-00489791
Trade Name: REVATIO 20 mg, comprimidos recubiertos con película
INN or Proposed INN: SILDENAFILO
Other descriptive name: SILDENAFIL
Pfizer, S.A.NULLNot RecruitingFemale: yes
Male: yes
79Phase 2Belgium;Spain;Germany;Sweden
66NCT00780728
(ClinicalTrials.gov)
December 200827/10/2008Study Evaluating the Addition of Sildenafil to Bosentan Therapy in Pulmonary Arterial HypertensionAddition of Sildenafil to Bosentan Monotherapy in Patients With Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: SildenafilUniversity Health Network, TorontoNULLWithdrawn18 YearsN/ABothPhase 3Canada
67NCT00795639
(ClinicalTrials.gov)
December 200820/11/2008Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS)A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Pulmonary HypertensionDrug: Sitaxsentan;Drug: PlaceboPfizerNULLTerminated16 Years80 YearsAll183Phase 3United States;Argentina;Bulgaria;Chile;China;Colombia;Costa Rica;Czech Republic;Dominican Republic;Guatemala;India;Malaysia;Mexico;Peru;Philippines;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;South Africa;Thailand;Turkey;Ukraine;Egypt;Jordan;Lebanon;United Arab Emirates
68EUCTR2006-001464-23-GR
(EUCTR)
04/11/200830/01/2009A 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: 9.1;Level: LLT;Classification code 10064911;Term: 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
69EUCTR2006-006748-76-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
70EUCTR2006-006748-76-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
71NCT00800592
(ClinicalTrials.gov)
October 200819/11/2008Sildenafil IV Bolus StudyAn Open Single Dose Study To Assess The Safety, Tolerability And Pharmacokinetics Of An Intravenous Bolus Dose (10 Mg) Of Sildenafil In Patients With Pulmonary Arterial Hypertension (PAH).Hypertension, PulmonaryDrug: sildenafilPfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted18 YearsN/AAll12Phase 1Belgium
72NCT00866983
(ClinicalTrials.gov)
October 200820/3/2009Local Open-Label Access Study For Patients Who Completed A1481244 Study In BrazilA Local, Multi-Centre, Extension, Open Label Access Study, To Provide Sildenafil Therapy For Patients Who Completed A1481244 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil , Prior To Reimbursement And Availability For Patients In Brazil.Pulmonary Arterial HypertensionDrug: sildenafil (Revatio) 20 mg TIDPfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLNo longer available18 YearsN/AAllBrazil
73EUCTR2005-005068-97-GR
(EUCTR)
23/09/200820/02/2009Effects 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: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203/029
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
180Phase 4Portugal;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Sweden
74JPRN-UMIN000001350
2008/09/0101/10/2008Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases 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
75NCT00742014
(ClinicalTrials.gov)
August 200825/8/2008The Assessment of Right Ventricular Contractility in Response to SildenafilThe Assessment of Right Ventricular Contractility in Response to Sildenafil in Pediatric Patients With Pulmonary Arterial HypertensionHypertensionDrug: SildenafilThe Hospital for Sick ChildrenNULLTerminated1 Year18 YearsAll10Phase 3Canada
76EUCTR2006-006748-76-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
77EUCTR2006-006748-76-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
78EUCTR2005-005068-97-PT
(EUCTR)
06/06/200811/03/2008Effects 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: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
MedDRA version: 9.1;Classification code 10064909;Term:
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203/029
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
79EUCTR2005-005068-97-ES
(EUCTR)
11/05/200803/03/2008Effects 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 studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - 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 studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2 Hipertensión Arterial PulmonarPatients 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: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
MedDRA version: 9.1;Classification code 10064909;Term:
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
180Phase 4Portugal;Czech Republic;Slovakia;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
80EUCTR2006-006748-76-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
81EUCTR2006-006748-76-IT
(EUCTR)
21/04/200821/02/2008A 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: 9.1;Level: LLT;Classification code 10037400;Term: 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
82NCT00430716
(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
83NCT00617305
(ClinicalTrials.gov)
April 20086/2/2008Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)An Open-label, Multicenter Study of Ambrisentan and a Phosphodiesterase Type-5 Inhibitor Combination Therapy in Subjects With Pulmonary Arterial Hypertension Who Have Demonstrated a Sub-Optimal Response to a Phosphodiesterase Type-5 InhibitorPulmonary Arterial HypertensionDrug: Ambrisentan;Drug: Placebo;Drug: Sildenafil;Drug: TadalafilGilead SciencesNULLCompleted16 Years75 YearsAll38Phase 4United States
84EUCTR2005-005068-97-SK
(EUCTR)
06/03/200806/07/2010A clinical trial to investigate the safety and effectiveness of the combination of bosentan and sildenafil to treat patients with symptomatic pulmonary arterial hypertension in comparison to treatment with sildenafil on its ownEffects 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: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;United Kingdom;Czech Republic;Belgium;Brazil;Denmark;Germany;Sweden
85EUCTR2006-006748-76-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
86EUCTR2007-002774-64-DE
(EUCTR)
04/12/200720/08/2007Therapy 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
87NCT00586794
(ClinicalTrials.gov)
December 200721/12/2007Therapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger PatientsTherapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger PatientsPulmonary Arterial Hypertension (PAH)Drug: Sildenafil;Drug: PlaceboCompetence Network for Congenital Heart DefectsGerman Federal Ministry of Education and ResearchTerminated14 YearsN/ABoth24Phase 3Germany
88EUCTR2005-005068-97-GB
(EUCTR)
30/10/200714/06/2007Effects 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: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 9.1;Classification code 10064910;Term: 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
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Phase 4Portugal;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Sweden
89EUCTR2005-005068-97-DK
(EUCTR)
12/09/200711/05/2007Effects 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: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 9.1;Classification code 10064910;Term: 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
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
90EUCTR2005-005068-97-SE
(EUCTR)
18/06/200702/04/2007Effects 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: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 9.1;Classification code 10064910;Term: 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
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
91EUCTR2006-004705-26-GB
(EUCTR)
10/05/200717/04/2007Safety 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: 8.1;Level: LLT;Classification code 10058554;Term: 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
92EUCTR2005-006192-13-PT
(EUCTR)
26/04/200730/11/2006A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of the addition of inhaled iloprost in patients with pulmonary arterial hypertension (PAH) receiving oral sildenafil - VISIONA randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of the addition of inhaled iloprost in patients with pulmonary arterial hypertension (PAH) receiving oral sildenafil - VISION Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death.
MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Ventavis
Product Name: Iloprost (Ventavis®)
INN or Proposed INN: Iloprost
CoTherix, IncNULLNot RecruitingFemale: yes
Male: yes
180Portugal;Germany;United Kingdom;Spain;Italy;Austria
93EUCTR2005-000963-25-SK
(EUCTR)
20/04/200720/03/2007A 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: 8.1;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
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
94NCT00454207
(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
95EUCTR2005-000963-25-FI
(EUCTR)
28/03/200709/01/2007A 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: 8.1;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
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
96EUCTR2006-002235-25-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
97EUCTR2006-002235-25-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
98NCT00433329
(ClinicalTrials.gov)
March 20077/2/2007Combination Therapy in Pulmonary Arterial HypertensionCOMPASS 3: An Open-label, Multi-Center Study Employing a Targeted 6-Minute Walk Test (6-MWT) Distance Threshold Approach to Guide Bosentan-Based Therapy and to Assess the Utility of Magnetic Resonance Imaging (MRI) on Cardiac RemodelingPulmonary Arterial HypertensionDrug: Bosentan;Drug: SildenafilActelionNULLCompleted12 YearsN/AAll100Phase 4United States
99NCT00625079
(ClinicalTrials.gov)
February 200719/2/2008Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With SildenafilRandomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot StudyPulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis;Interstitial Lung Disease;Pulmonary HypertensionDrug: sildenafilUniversity of California, Los AngelesPfizerWithdrawnN/AN/AAll0Phase 4United States
100JPRN-C000000340
2007/01/0101/03/2006Effects of phosphodiesterase V (sildenafil) on pulmonary arterial hypertension Pulmonary arterial hypertensionTreatment with sildenafil 25mg three times daily for 24 weeks
Treatment with prior therapy without sildenafil for 24 weeks
Division of cardiovascular internal medicine, The University of Tokyo HospitalNULLComplete: follow-up complete18years-old80years-oldMale and Female20Phase 2,3Japan
101EUCTR2006-002235-25-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
102EUCTR2006-001464-23-IT
(EUCTR)
03/11/200619/02/2007A 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 - NDA 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 - ND Pulmonary Arterial Hypertension PAH .
MedDRA version: 6.1;Level: PT;Classification code 10037400
Trade Name: G04BE03- Sildenafil - sildenafil (citrato)
Product Name: Sildenafil
INN or Proposed INN: Sildenafil
PFIZERNULLNot RecruitingFemale: yes
Male: yes
106Czech Republic;Greece;Germany;United Kingdom;Italy
103EUCTR2006-001464-23-GB
(EUCTR)
18/10/200611/06/2006A 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: 8.0;Level: LLT;Classification code 10064911
Product Name: Revatio®
Product Code: UK-92,480
INN or Proposed INN: Sildenafil
Pfizer LtdNULLNot Recruiting Female: yes
Male: yes
106 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yesCzech Republic;Greece;Germany;Italy;United Kingdom
104EUCTR2005-006192-13-IT
(EUCTR)
19/09/200612/04/2007A Randomized, Double-blind,Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients with Pulmonary Arterial Hypertension Receiving Oral Sildenafil - VISION A Randomized, Double-blind,Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients with Pulmonary Arterial Hypertension Receiving Oral Sildenafil - VISION primary pulmonary hypertension ICD IX 416.8
MedDRA version: 9.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: ventavis
INN or Proposed INN: Iloprost
COTHERIX, INC.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3Portugal;Spain;Austria;Germany;United Kingdom;Italy
105EUCTR2005-000963-25-GB
(EUCTR)
13/09/200619/09/2006A 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: 8.1;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
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
106NCT00323297
(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
107EUCTR2005-006192-13-DE
(EUCTR)
06/07/200603/05/2006A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISIONA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death.
MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Ventavis
Product Name: Iloprost (Ventavis®)
INN or Proposed INN: Iloprost
Actelion Pharmaceuticals US, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Portugal;United Kingdom;Germany;Spain;Italy;Austria
108EUCTR2006-001464-23-DE
(EUCTR)
04/07/200605/05/2006A 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: 14.1;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
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
109EUCTR2005-006192-13-GB
(EUCTR)
22/06/200621/03/2006A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISIONA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death.
MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Ventavis
Product Name: Iloprost (Ventavis®)
INN or Proposed INN: Iloprost
Actelion Pharmaceuticals US, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Portugal;Germany;United Kingdom;Spain;Italy;Austria
110EUCTR2005-006192-13-ES
(EUCTR)
09/06/200612/05/2006Estudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISIONEstudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISION Spanish: hipertensión arterial pulmonar English: Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death.
MedDRA version: 8.1;Classification code 10037400
Trade Name: **Comment**- IMP inhalation solution identical to ventavis inhalation solution, but IMP is in a different volume presentation. Please see covering letter.
Product Name: Iloprost (Ventavis®)
INN or Proposed INN: Iloprost
CoTherix, IncNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Portugal;Spain;Austria;Germany;Italy;United Kingdom
111EUCTR2005-005066-37-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
112EUCTR2006-001464-23-CZ
(EUCTR)
08/06/200621/04/2006A 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: 9.1;Level: LLT;Classification code 10064911;Term: 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
113NCT00946114
(ClinicalTrials.gov)
June 200622/7/2009To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 WeeksA Local, Multi-Centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For One Hundred Twelve Weeks / Prior To Reimbursement And Availability For Patients In Poland.Pulmonary HypertensionDrug: sildenafilPfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted18 YearsN/AAll32Poland
114EUCTR2005-006192-13-AT
(EUCTR)
15/05/200605/05/2006A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISIONA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death.
MedDRA version: 8.1;Level: LLT;Classification code 10037400;Term: Pulmonary hypertension
Trade Name: Ventavis
Product Name: Iloprost (Ventavis®)
INN or Proposed INN: Iloprost
Actelion Pharmaceuticals US, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Portugal;Germany;United Kingdom;Spain;Italy;Austria
115NCT00303459
(ClinicalTrials.gov)
May 200616/3/2006Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH)Effects 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 StudyPulmonary Arterial HypertensionDrug: bosentan;Drug: placeboActelionNULLCompleted12 YearsN/AAll334Phase 4United States;Brazil;Czech Republic;Denmark;Germany;Greece;Portugal;Saudi Arabia;Slovakia;Spain;Sweden;United Kingdom
116EUCTR2005-005066-37-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
117EUCTR2005-005066-37-IT
(EUCTR)
21/03/200605/06/2006Hemodynamic 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 1Hemodynamic 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 Patients suffering from pulmonary arterial hypertension PAH
MedDRA version: 6.1;Level: PT;Classification code 10037400
INN or Proposed INN: SildenafilActelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
44Phase 2Germany;United Kingdom;Italy
118EUCTR2005-005066-37-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
119EUCTR2006-000021-57-DK
(EUCTR)
10/03/200624/02/2006Bosentan and Sildenfil for patients with Eisenmenger syndromeBosentan and Sildenfil for patients with Eisenmenger syndrome Eisenmengers syndrome is condition with severe pulmonary arterial hypertension due to a shunting of blood from the left side of the heart to the right side of the heart. When the pressure in the pulmonary arteries levels the systemic blood pressure, blood begins to shunt from the right side of the heart to the left side of the heart leading to a condition with cyanosis, impaired physical capacity and increased mortality (Eisenmengers syndrome).Trade Name: Tracleer
Product Name: Tracleer
Other descriptive name: Bosentan monohydrat
Trade Name: VIAGRA
Product Name: Viagra
Other descriptive name: sildenafil
RigshospitaletNULLNot RecruitingFemale: yes
Male: yes
20Denmark
120NCT00303004
(ClinicalTrials.gov)
March 200614/3/2006Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers SyndromeCombination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers SyndromeEisenmenger SyndromeDrug: Bosentan and SildenafilRigshospitalet, DenmarkNULLCompleted18 YearsN/ABoth20Phase 3Denmark
121NCT00302211
(ClinicalTrials.gov)
February 1, 200610/3/2006The VISION Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial HypertensionA Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients With Pulmonary Arterial Hypertension Receiving Oral SildenafilPulmonary HypertensionDrug: Inhaled Iloprost (5 µg);Drug: Inhaled Placebo;Drug: Sildenafil;Drug: BosentanActelionNULLTerminated12 Years85 YearsAll67Phase 3United States
122EUCTR2005-000963-25-SE
(EUCTR)
30/05/200506/04/2005Oral 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: 14.1;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]
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
123NCT00159874
(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
124NCT00483626
(ClinicalTrials.gov)
August 20036/6/2007Hemodynamic Response After Six Months of SildenafilHemodynamic Evaluation of Patients With Pulmonary Arterial Hypertension. Response to Sildenafil TreatmentPulmonary Arterial HypertensionDrug: oral sildenafilUniversity of ChileNULLRecruiting16 Years75 YearsBoth27Phase 4Chile
125NCT00159913
(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
126NCT00159861
(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
127NCT00159887
(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
128NCT00644605
(ClinicalTrials.gov)
October 200220/3/2008A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial HypertensionA Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and OverHypertension, PulmonaryDrug: sildenafil;Drug: placeboPfizer's Upjohn has merged with Mylan to form Viatris Inc.NULLCompleted18 YearsN/AAll275Phase 3United States;Australia;Belgium;Brazil;Czechia;Denmark;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Norway;Poland;Singapore;South Africa;Spain;Sweden;United Kingdom;Czech Republic
129EUCTR2016-003978-41-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
130EUCTR2015-002238-37-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
131EUCTR2006-002235-25-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
132EUCTR2014-004167-20-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
133EUCTR2005-005068-97-DE
(EUCTR)
13/02/2006Effects 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: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 9.1;Classification code 10064910;Term: 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
134EUCTR2005-000963-25-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