86. Pulmonary arterial hypertension
1,083 clinical trials,   667 drugs   (DrugBank: 122 drugs),   98 drug target genes,   185 drug target pathways

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

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
49 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-004362-34-LV
(EUCTR)
03/10/201802/07/2018A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSIONA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) Pulmonary Arterial Hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Product Name: Sildenafil
Product Code: UK 092480
INN or Proposed INN: Sildenafil
Other descriptive name: SILDENAFIL CITRATE
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot RecruitingFemale: yes
Male: yes
429Phase 3;Phase 4United States;Portugal;Serbia;Hong Kong;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Malaysia;Australia;South Africa;Latvia;Netherlands;Bosnia and Herzegovina;Turkey;Austria;Czech Republic;Mexico;Belgium;Poland;Singapore;Croatia;Romania;Germany;Sweden
2EUCTR2013-004362-34-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
3EUCTR2013-004362-34-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]
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
429Phase 3;Phase 4Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
4EUCTR2013-004362-34-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: 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 4Serbia;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
5EUCTR2013-004362-34-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2013-004362-34-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 4Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
7EUCTR2013-004362-34-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 4Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
8EUCTR2013-004362-34-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
9NCT02060487
(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 citratePfizerNULLActive, not recruiting18 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
10EUCTR2013-004362-34-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 10017NULLAuthorised-recruitment may be ongoing or finishedFemale: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2013-004362-34-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 4Turkey;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
12EUCTR2013-004362-34-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 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
13EUCTR2013-004362-34-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]
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
429Phase 3Serbia;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
14EUCTR2013-004362-34-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]
Pfizer Inc., 235 East 42nd Street, New York, NY 10017NULLNot Recruiting Female: yes
Male: yes
429Phase 3;Phase 4Serbia;Portugal;United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
15NCT01409122
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2006-006748-76-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
17EUCTR2006-001464-23-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
18EUCTR2006-006748-76-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
19EUCTR2006-006748-76-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)Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot Recruiting Female: yes
Male: yes
219Phase 4Greece;Belgium;Denmark;Bulgaria;Latvia;Netherlands;Italy;United Kingdom
20EUCTR2006-006748-76-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2006-006748-76-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
22EUCTR2006-006748-76-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
23EUCTR2006-006748-76-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
24NCT00430716
(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
25EUCTR2006-006748-76-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2005-006192-13-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
27EUCTR2005-000963-25-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
28EUCTR2005-000963-25-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
29EUCTR2006-002235-25-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
30EUCTR2006-002235-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2006-002235-25-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
Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United KingdomNULLNot Recruiting Female: yes
Male: yes
200Phase 3Slovakia;Finland;United Kingdom
32EUCTR2006-001464-23-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
33EUCTR2006-001464-23-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
Pfizer LtdNULLNot Recruiting Female: yes
Male: yes
106Phase 4Czech Republic;Greece;Germany;Italy;United Kingdom
34EUCTR2005-006192-13-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 - 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 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Portugal;Germany;United Kingdom;Spain;Italy;Austria
35EUCTR2005-000963-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT00323297
(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 CitratePfizerNULLCompleted18 YearsN/AAll105Phase 4United States;Australia;Czech Republic;France;Germany;Greece;Israel;Italy;Taiwan;United Kingdom;Belgium
37EUCTR2005-006192-13-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
38EUCTR2006-001464-23-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
39EUCTR2005-006192-13-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
40EUCTR2006-001464-23-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2005-006192-13-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
42NCT00302211
(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
43EUCTR2005-000963-25-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
44NCT00159874
(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 citratePfizerNULLCompleted1 Year17 YearsAll234Phase 3United States;Brazil;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;Sweden;Taiwan;Canada;Costa Rica;Panama;Singapore
45NCT00483626
(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
No.TrialIDDate_
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agemin
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PhaseCountries
46NCT00159913
(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
47NCT00159887
(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 citratePfizerNULLCompleted18 YearsN/ABoth260Phase 3United 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
48EUCTR2006-002235-25-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
49EUCTR2005-000963-25-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