Oral sildenafil (DrugBank: Sildenafil)
17 diseases告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
6 | パーキンソン病 | 0 |
46 | 悪性関節リウマチ | 0 |
50 | 皮膚筋炎/多発性筋炎 | 0 |
51 | 全身性強皮症 | 0 |
85 | 特発性間質性肺炎 | 6 |
86 | 肺動脈性肺高血圧症 | 49 |
90 | 網膜色素変性症 | 0 |
113 | 筋ジストロフィー | 0 |
210 | 単心室症 | 0 |
211 | 左心低形成症候群 | 0 |
212 | 三尖弁閉鎖症 | 0 |
225 | 先天性腎性尿崩症 | 0 |
226 | 間質性膀胱炎(ハンナ型) | 1 |
278 | 巨大リンパ管奇形(頚部顔面病変) | 1 |
294 | 先天性横隔膜ヘルニア | 0 |
299 | 嚢胞性線維症 | 0 |
301 | 黄斑ジストロフィー | 0 |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | EUCTR2015-002619-14-FR (EUCTR) | 21/06/2017 | 25/04/2018 | Efficacy and safety of nintedanib co-administered with sildenafil in IPF patients with advanced lung function impairment | A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Italy;United Kingdom;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of | ||
2 | EUCTR2015-002619-14-GB (EUCTR) | 01/08/2016 | 08/09/2016 | Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment | INSTAGE(TM): A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM) | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 19.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of | |||
3 | EUCTR2015-002619-14-BE (EUCTR) | 25/07/2016 | 03/06/2016 | Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment | INSTAGE (TM) : A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE (TM) | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 20.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil | SCS Boehringer Ingelheim Comm. V | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of | ||
4 | EUCTR2015-002619-14-DE (EUCTR) | 21/07/2016 | 04/05/2016 | Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment | INSTAGE(TM): A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment - INSTAGE(TM) | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of | ||
5 | NCT02802345 (ClinicalTrials.gov) | June 30, 2016 | 14/6/2016 | Efficacy and Safety of Nintedanib Co-administered With Sildenafil in Idiopathic Pulmonary Fibrosis Patients With Advanced Lung Function Impairment | INSTAGE: A 24-week, Double-blind, Randomized, Parallel-group Study Evaluating the Efficacy and Safety of Oral Nintedanib Co-administered With Oral Sildenafil, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Advanced Lung Function Impairment | Idiopathic Pulmonary Fibrosis | Drug: Nintedanib;Drug: Placebo;Drug: Sildenafil | Boehringer Ingelheim | NULL | Completed | 40 Years | N/A | All | 274 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;India;Italy;Japan;Korea, Republic of;Mexico;Spain;United Kingdom |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
6 | EUCTR2015-002619-14-ES (EUCTR) | 29/06/2016 | 17/05/2016 | Efficacy and safety of nintedanib when co-administered with sildenafil in IPF patients with advanced lung function impairment | A 24-week, double-blind, randomized, parallel-group study evaluating the efficacy and safety of oral nintedanib coadministrated with oral sildenafil, compared to treatment with nintedanib alone, in patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment | patients with idiopathic pulmonary fibrosis (IPF) and advanced lung function impairment MedDRA version: 19.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Ofev 100 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Ofev 150 mg capsule Product Code: nintedanib INN or Proposed INN: nintedanib Other descriptive name: NINTEDANIB Trade Name: Revatio Product Name: Revatio 20 mg Product Code: sildenafil INN or Proposed INN: SILDENAFIL Other descriptive name: sildenafil | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;United Kingdom;Italy;India;France;Mexico;Canada;Belgium;Australia;Germany;China;Japan;Korea, Republic of |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | EUCTR2013-004362-34-LV (EUCTR) | 03/10/2018 | 02/07/2018 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3;Phase 4 | United 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 | ||
2 | EUCTR2013-004362-34-HR (EUCTR) | 21/10/2015 | 26/05/2015 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A 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 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 429 | United 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 | |||
3 | EUCTR2013-004362-34-SE (EUCTR) | 26/08/2015 | 13/03/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A 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] | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 429 | Phase 3;Phase 4 | Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | |||
4 | EUCTR2013-004362-34-PT (EUCTR) | 08/05/2015 | 18/02/2015 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3;Phase 4 | Serbia;United States;Portugal;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
5 | EUCTR2013-004362-34-NL (EUCTR) | 23/04/2015 | 29/01/2015 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3;Phase 4 | Serbia;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 | ||
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
6 | EUCTR2013-004362-34-GR (EUCTR) | 21/11/2014 | 24/11/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 4 | Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
7 | EUCTR2013-004362-34-PL (EUCTR) | 22/10/2014 | 17/07/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3;Phase 4 | Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
8 | EUCTR2013-004362-34-RO (EUCTR) | 25/09/2014 | 30/05/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A 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 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 429 | Serbia;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 | |||
9 | NCT02060487 (ClinicalTrials.gov) | September 22, 2014 | 29/1/2014 | Effects of Oral Sildenafil on Mortality in Adults With PAH | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension | Drug: sildenafil citrate | Pfizer | NULL | Active, not recruiting | 18 Years | 74 Years | All | 385 | Phase 4 | United 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 |
10 | EUCTR2013-004362-34-CZ (EUCTR) | 08/09/2014 | 13/05/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A 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 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 429 | Phase 3;Phase 4 | United 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 | ||
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
11 | EUCTR2013-004362-34-DE (EUCTR) | 30/07/2014 | 25/03/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A 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 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3;Phase 4 | Turkey;Austria;Czech Republic;Mexico;Belgium;Poland;Singapore;Croatia;Romania;Germany;Sweden;United States;Portugal;Serbia;Hong Kong;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Malaysia;Australia;South Africa;Latvia;Netherlands;Bosnia and Herzegovina | ||
12 | EUCTR2013-004362-34-ES (EUCTR) | 30/06/2014 | 08/05/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A 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 10017 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 429 | Serbia;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 | |||
13 | EUCTR2013-004362-34-BE (EUCTR) | 12/06/2014 | 17/03/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A 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] | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3 | Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | |||
14 | EUCTR2013-004362-34-AT (EUCTR) | 12/05/2014 | 13/03/2014 | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION | A 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] | Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | NULL | Not Recruiting | Female: yes Male: yes | 429 | Phase 3;Phase 4 | Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | |||
15 | NCT01409122 (ClinicalTrials.gov) | July 2011 | 1/8/2011 | Safety, Tolerability, and PK Parameters of Sodium Nitrite Inhalation Solution in Healthy Subjects | A 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 Hypertension | Pulmonary Hypertension;Pulmonary Arterial Hypertension | Drug: 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 solution | Aires Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 56 Years | Both | 42 | Phase 1 | United States |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
16 | EUCTR2006-006748-76-BG (EUCTR) | 30/01/2009 | 06/01/2009 | A 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 | A 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, UK | NULL | Not Recruiting | Female: yes Male: yes | 219 | United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia | |||
17 | EUCTR2006-001464-23-GR (EUCTR) | 04/11/2008 | 30/01/2009 | 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 | 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: 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 9NJ | NULL | Not Recruiting | Female: yes Male: yes | 106 | Czech Republic;Greece;Germany;Italy;United Kingdom | |||
18 | EUCTR2006-006748-76-LV (EUCTR) | 22/10/2008 | 10/06/2008 | A 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 | A 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, UK | NULL | Not Recruiting | Female: yes Male: yes | 219 | United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia | |||
19 | EUCTR2006-006748-76-GB (EUCTR) | 15/10/2008 | 02/09/2008 | A 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 | A 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) | Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK | NULL | Not Recruiting | Female: yes Male: yes | 219 | Phase 4 | Greece;Belgium;Denmark;Bulgaria;Latvia;Netherlands;Italy;United Kingdom | |||
20 | EUCTR2006-006748-76-GR (EUCTR) | 24/06/2008 | 14/03/2008 | A 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 | A 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, UK | NULL | Not Recruiting | Female: yes Male: yes | 284 | United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia | |||
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
21 | EUCTR2006-006748-76-BE (EUCTR) | 10/06/2008 | 29/01/2008 | A 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 | A 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 UK | NULL | Not Recruiting | Female: yes Male: yes | 219 | United Kingdom;Netherlands;Denmark;Belgium;Bulgaria;Italy;Greece;Latvia | |||
22 | EUCTR2006-006748-76-NL (EUCTR) | 23/04/2008 | 01/11/2007 | A 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 | A 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, UK | NULL | Not Recruiting | Female: yes Male: yes | 284 | United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia | |||
23 | EUCTR2006-006748-76-IT (EUCTR) | 21/04/2008 | 21/02/2008 | A 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 | A 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 | PFIZER | NULL | Not Recruiting | Female: yes Male: yes | 284 | United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia | |||
24 | NCT00430716 (ClinicalTrials.gov) | April 8, 2008 | 31/1/2007 | To 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 Hypertension | Drug: Sildenafil citrate | Pfizer | NULL | Terminated | 18 Years | N/A | All | 130 | Phase 4 | United States;Belgium;Brazil;Bulgaria;China;Greece;India;Italy;Latvia;Malaysia;Netherlands;Philippines;Poland;Romania;Russian Federation;Thailand;United Kingdom;Denmark;Panama |
25 | EUCTR2006-006748-76-DK (EUCTR) | 21/01/2008 | 09/01/2008 | A 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 | A 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 UK | NULL | Not Recruiting | Female: yes Male: yes | 219 | Greece;Belgium;Denmark;Bulgaria;Latvia;Netherlands;United Kingdom;Italy | |||
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
26 | EUCTR2005-006192-13-PT (EUCTR) | 26/04/2007 | 30/11/2006 | 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 (PAH) 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 (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, Inc | NULL | Not Recruiting | Female: yes Male: yes | 180 | Portugal;Germany;United Kingdom;Spain;Italy;Austria | |||
27 | EUCTR2005-000963-25-SK (EUCTR) | 20/04/2007 | 20/03/2007 | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A | 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: 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, UK | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 3 | Slovakia;Finland;United Kingdom;Sweden | ||
28 | EUCTR2006-002235-25-FI (EUCTR) | 28/03/2007 | 09/01/2007 | 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 - N/A | 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 - 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 Kingdom | NULL | Not Recruiting | Female: yes Male: yes | 204 | Finland;United Kingdom | |||
29 | EUCTR2005-000963-25-FI (EUCTR) | 28/03/2007 | 09/01/2007 | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A | 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: 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, UK | NULL | Not Recruiting | Female: yes Male: yes | 185 | Finland;United Kingdom;Sweden | |||
30 | EUCTR2006-002235-25-SK (EUCTR) | 22/03/2007 | 13/02/2007 | 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 - N/A | 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 - 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 Kingdom | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | Slovakia;Finland;United Kingdom | ||
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
31 | EUCTR2006-002235-25-GB (EUCTR) | 14/12/2006 | 18/09/2006 | 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 - N/A | 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 - N/A | Pulmonary Arterial Hypertension MedDRA version: 9.0;Level: LLT;Classification code 10064911 | Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United Kingdom | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Slovakia;Finland;United Kingdom | |||
32 | EUCTR2006-001464-23-IT (EUCTR) | 03/11/2006 | 19/02/2007 | 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 TREATMENT OF SUBJECTS, AGED 18 YEARS AND ABOVE, WITH PULMONARY ARTERIAL HYPERTENSION PAH - ND | 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 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 | PFIZER | NULL | Not Recruiting | Female: yes Male: yes | 106 | Czech Republic;Greece;Germany;United Kingdom;Italy | |||
33 | EUCTR2006-001464-23-GB (EUCTR) | 18/10/2006 | 11/06/2006 | 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 | 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: 8.0;Level: LLT;Classification code 10064911 | Pfizer Ltd | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 4 | Czech Republic;Greece;Germany;Italy;United Kingdom | |||
34 | EUCTR2005-006192-13-IT (EUCTR) | 19/09/2006 | 12/04/2007 | 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 | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Portugal;Germany;United Kingdom;Spain;Italy;Austria | |||
35 | EUCTR2005-000963-25-GB (EUCTR) | 13/09/2006 | 19/09/2006 | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A | 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: 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, UK | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Slovakia;Finland;United Kingdom;Sweden | ||
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
36 | NCT00323297 (ClinicalTrials.gov) | September 2006 | 5/5/2006 | Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary 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 Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah) | Pulmonary Arterial Hypertension | Drug: Bosentan;Other: Placebo;Drug: Sildenafil Citrate | Pfizer | NULL | Completed | 18 Years | N/A | All | 105 | Phase 4 | United States;Australia;Czech Republic;France;Germany;Greece;Israel;Italy;Taiwan;United Kingdom;Belgium |
37 | EUCTR2005-006192-13-DE (EUCTR) | 06/07/2006 | 03/05/2006 | 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 (PAH) 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 (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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Portugal;United Kingdom;Germany;Spain;Italy;Austria | |||
38 | EUCTR2006-001464-23-DE (EUCTR) | 04/07/2006 | 05/05/2006 | A 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, UK | NULL | Not Recruiting | Female: yes Male: yes | 106 | France;Czech Republic;Taiwan;Greece;Belgium;Australia;Israel;Germany;Italy;United Kingdom | |||
39 | EUCTR2005-006192-13-GB (EUCTR) | 22/06/2006 | 21/03/2006 | 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 (PAH) 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 (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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Portugal;Germany;United Kingdom;Spain;Italy;Austria | |||
40 | EUCTR2006-001464-23-CZ (EUCTR) | 08/06/2006 | 21/04/2006 | 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 | 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: 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 9NJ | NULL | Not Recruiting | Female: yes Male: yes | 106 | Czech Republic;Greece;Germany;Italy;United Kingdom | |||
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
41 | EUCTR2005-006192-13-AT (EUCTR) | 15/05/2006 | 05/05/2006 | 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 (PAH) 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 (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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Portugal;Germany;United Kingdom;Spain;Italy;Austria | |||
42 | NCT00302211 (ClinicalTrials.gov) | February 1, 2006 | 10/3/2006 | The VISION Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension | 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 | Pulmonary Hypertension | Drug: Inhaled Iloprost (5 µg);Drug: Inhaled Placebo;Drug: Sildenafil;Drug: Bosentan | Actelion | NULL | Terminated | 12 Years | 85 Years | All | 67 | Phase 3 | United States |
43 | EUCTR2005-000963-25-SE (EUCTR) | 30/05/2005 | 06/04/2005 | Oral 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] | 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, UK | NULL | Not Recruiting | Female: yes Male: yes | 200 | Taiwan;Finland;Thailand;Costa Rica;Guatemala;Chile;Russian Federation;Colombia;United Kingdom;Italy;India;Hungary;Mexico;Brazil;Malaysia;Poland;Sweden | |||
44 | NCT00159874 (ClinicalTrials.gov) | January 2004 | 8/9/2005 | A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil Citrate In The Treatment Of Subjects Who Have Completed Study A1481131 | Pulmonary Arterial Hypertension | Drug: Sildenafil citrate | Pfizer | NULL | Completed | 1 Year | 17 Years | All | 234 | Phase 3 | United States;Brazil;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;Sweden;Taiwan;Canada;Costa Rica;Panama;Singapore |
45 | NCT00159913 (ClinicalTrials.gov) | August 2003 | 8/9/2005 | A 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, Children | Drug: Sildenafil citrate;Drug: Placebo | Pfizer | NULL | Completed | 1 Year | 17 Years | All | 235 | Phase 3 | United States;Brazil;Canada;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Peru;Poland;Russian Federation;Sweden;Taiwan;Australia;Costa Rica;Panama;Singapore |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
46 | NCT00483626 (ClinicalTrials.gov) | August 2003 | 6/6/2007 | Hemodynamic Response After Six Months of Sildenafil | Hemodynamic Evaluation of Patients With Pulmonary Arterial Hypertension. Response to Sildenafil Treatment | Pulmonary Arterial Hypertension | Drug: oral sildenafil | University of Chile | NULL | Recruiting | 16 Years | 75 Years | Both | 27 | Phase 4 | Chile |
47 | NCT00159887 (ClinicalTrials.gov) | December 2002 | 8/9/2005 | Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension | A 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 Hypertension | Drug: Sildenafil citrate | Pfizer | NULL | Completed | 18 Years | N/A | Both | 260 | Phase 3 | United States;Australia;Belgium;Brazil;Czech Republic;Denmark;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Poland;Singapore;South Africa;Spain;Sweden;United Kingdom |
48 | EUCTR2005-000963-25-Outside-EU/EEA (EUCTR) | 07/03/2012 | Oral 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, UK | NULL | NA | Female: yes Male: yes | 220 | Russian Federation;Taiwan;United States;Brazil;Chile;Colombia;Guatemala;India;Japan;Malaysia;Mexico | ||||
49 | EUCTR2006-002235-25-Outside-EU/EEA (EUCTR) | 07/03/2012 | A 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 - 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 Kingdom | NULL | NA | Female: yes Male: yes | 235 | Brazil;Canada;Chile;Colombia;Guatemala;India;Japan;Malaysia;Mexico;Peru;Russian Federation;Taiwan;United States |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | ChiCTR-TRC-13003938 | 2009-06-01 | 2013-05-17 | Efficacy of daily low-dose sildenafil for treating interstitial cystitis: results of randomized, double-blind, placebo-controlled trial | Efficacy of daily low-dose sildenafil for treating interstitial cystitis: results of randomized, double-blind, placebo-controlled trial | interstitial cystitis | group A:oral sildenafil;group B:oral placebo ; | The First Af?liated Hospital of Wenzhou Medical College | NULL | Completed | 35 | 55 | Both | group A:24;group B:24; | China |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | ChiCTR-OPC-16008702 | 2014-05-01 | 2016-06-22 | Efficacy and safety of oral sildenafil in the treatment of pediatric lymphatic malformations in China | Sildenafil in the treatment of pediatric lymphatic malformations | pediatric lymphatic malformations | Sildenafil-treated group:oral sildenafil; | Beijing Children's Hospital | NULL | Recruiting | Both | Sildenafil-treated group:40; | China |