86. Pulmonary arterial hypertension Clinical trials / Disease details


Clinical trials : 1,181 Drugs : 701 - (DrugBank : 126) / Drug target genes : 105 - Drug target pathways : 192

  
26 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2020-005061-13-NL
(EUCTR)
09/02/202225/11/2021A Long-term Follow-up Study of Sotatercept for PAH TreatmentAn Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept - 60 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United States;Serbia;Portugal;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
2EUCTR2021-001498-21-DE
(EUCTR)
01/02/202224/09/2021A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of MortalityA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality - A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
166Phase 3France;United States;Mexico;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Italy
3EUCTR2020-005061-13-PL
(EUCTR)
26/01/202202/12/2021A Long-term Follow-up Study of Sotatercept for PAH TreatmentAn Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept - 60 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United States;Serbia;Portugal;Taiwan;Greece;Spain;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
4EUCTR2021-000199-12-HR
(EUCTR)
19/01/202203/02/2022A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients.A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
662Phase 3United States;Portugal;Serbia;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
5EUCTR2020-005061-13-SE
(EUCTR)
10/01/202212/10/2021A Long-term Follow-up Study of Sotatercept for PAH TreatmentAn Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept - 60 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Brazil;Belgium;Poland;Croatia;United States;Portugal;Serbia;Taiwan;Greece;Spain;Israel;Colombia;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Germany;New Zealand;Sweden
6EUCTR2021-003020-32-ES
(EUCTR)
03/01/202219/10/2021A Phase 2 Study of Sotatercept for Combined Postcapillary and Precapillary Pulmonary Hypertension TreatmentPhase 2, Double-blind, Randomized, Placebocontrolled Study to Evaluate the Effects of Sotatercept versus Placebo-Controlled for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF) - A Phase 2 Study of Sotatercept for Cpc-PH Treatment Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved EjectionFraction (HFpEF)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: SOTATERCEPT
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2France;United States;Canada;Belgium;Spain;Israel;Netherlands;Germany;United Kingdom;Italy;Sweden
7EUCTR2021-000199-12-CZ
(EUCTR)
29/11/202110/09/2021A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients.A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
662Phase 3United States;Serbia;Portugal;Taiwan;Greece;Spain;Israel;Colombia;Italy;Switzerland;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Germany;New Zealand;Sweden
8EUCTR2021-001498-21-NL
(EUCTR)
15/11/202114/09/2021A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of MortalityA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality - A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
166Phase 3France;United States;Mexico;Canada;Spain;Belgium;Australia;Israel;Germany;Netherlands;United Kingdom;Italy
9EUCTR2021-001498-21-ES
(EUCTR)
11/11/202131/08/2021A study to evaluate Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of MortalityA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality - A Phase3 Study of Sotatercept in Participants with PAH WHO FC III or FC IV at High Risk of Mortality Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
166Phase 3France;United States;Mexico;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;United Kingdom;Italy
10EUCTR2021-000199-12-ES
(EUCTR)
27/10/202123/08/2021A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients.A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
662Phase 3United States;Serbia;Portugal;Taiwan;Greece;Spain;Ireland;Israel;Chile;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
11EUCTR2021-000199-12-NL
(EUCTR)
20/10/202130/08/2021A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients.A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
662Phase 3United States;Serbia;Portugal;Taiwan;Greece;Spain;Israel;Colombia;Italy;Switzerland;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Germany;New Zealand;Sweden
12EUCTR2021-000199-12-DE
(EUCTR)
19/10/202119/08/2021A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients.A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
662Phase 3United States;Serbia;Portugal;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
13EUCTR2021-000199-12-SE
(EUCTR)
04/10/202105/08/2021A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk Pulmonary arterial hypertension (PAH) Patients.A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension(PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients. - A Phase 3 Study of Sotatercept in Newly Diagnosed Intermediate- and High-risk PAH Patients Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
662Phase 3United States;Serbia;Portugal;Taiwan;Greece;Spain;Ireland;Israel;Chile;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
14EUCTR2020-005061-13-ES
(EUCTR)
06/07/202108/07/2021A Long-term Follow-up Study of Sotatercept for PAH TreatmentAn Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Serbia;United States;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
15EUCTR2020-004142-11-PL
(EUCTR)
24/06/202123/03/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
284Phase 3United States;Serbia;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
16EUCTR2020-005061-13-DE
(EUCTR)
22/06/202124/02/2021A Long-term Follow-up Study of Sotatercept for PAH TreatmentAn Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Long-term Follow-up Study of Sotatercept for PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept - 60 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United States;Portugal;Serbia;Taiwan;Greece;Spain;Ireland;Israel;Colombia;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden
17EUCTR2020-004142-11-DE
(EUCTR)
12/05/202119/01/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
284Phase 3Serbia;United States;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
18EUCTR2020-004142-11-BE
(EUCTR)
15/04/202108/02/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
284Phase 3United States;Serbia;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
19EUCTR2020-004142-11-SE
(EUCTR)
26/03/202128/01/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
284Phase 3Serbia;United States;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
20EUCTR2020-004142-11-NL
(EUCTR)
24/03/202117/02/2021A Phase 3 Study of Sotatercept for the Treatment of PAHA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH - A Phase 3 Study of Sotatercept for the Treatment of PAH Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
284Phase 3United States;Serbia;Czechia;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
21NCT03738150
(ClinicalTrials.gov)
May 1, 20192/11/2018A Study of Sotatercept for the Treatment of Pulmonary Arterial HypertensionA Phase 2a Single-Arm, Open-Label, Multicenter Exploratory Study to Assess the Effects of Sotatercept (ACE-011) for the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionBiological: SotaterceptAcceleron Pharma Inc.NULLActive, not recruiting18 YearsN/AAll21Phase 2United States
22EUCTR2017-004738-27-BE
(EUCTR)
04/01/201931/08/2018A Phase 2 Study of Sotatercept for the Treatment of PAHA Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Brazil;Spain;Belgium;Australia;Israel;Germany;United Kingdom
23EUCTR2017-004738-27-GB
(EUCTR)
18/10/201824/06/2019A Phase 2 Study of Sotatercept for the Treatment of PAHA Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Brazil;Belgium;Spain;Australia;Israel;Germany;United Kingdom
24EUCTR2017-004738-27-ES
(EUCTR)
04/09/201805/09/2018A Phase 2 Study of Sotatercept for the Treatment of PAHA Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2United States;France;Brazil;Belgium;Spain;Australia;Israel;Germany;United Kingdom
25EUCTR2017-004738-27-DE
(EUCTR)
15/08/201803/08/2018A Phase 2 Study of Sotatercept for the Treatment of PAHA Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10077739;Term: Pulmonary arterial hypertension WHO functional class I;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Sotatercept
Product Code: ACE-011
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2United States;France;Spain;Brazil;Belgium;Australia;Israel;Germany;United Kingdom
26NCT03496207
(ClinicalTrials.gov)
June 27, 201829/3/2018A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH)A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Placebo;Drug: SotaterceptAcceleron Pharma Inc.NULLActive, not recruiting18 YearsN/AAll106Phase 2United States;Australia;Brazil;France;Germany;Israel;Spain;United Kingdom