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


臨床試験数 : 1,205 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193

  
10 trials found
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1NCT05587712
(ClinicalTrials.gov)
January 19, 202317/10/2022Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children From 1 to Less Than 18 Years of Age With PAH on Standard of CarePulmonary Arterial HypertensionDrug: SotaterceptMerck Sharp & Dohme LLCNULLRecruiting1 Year17 YearsAll42Phase 2United States
2EUCTR2022-000478-25-ES
(EUCTR)
23/12/202213/10/2022Sotatercept in Children with Pulmonary Artery Hypertension on Standard of CareA Phase 2 Open-label Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children from 1 to Less Than 18 Years of Age With PAH on Standard of Care - Sotatercept in Children with PAH on SoC Pulmonary arterial hypertension
MedDRA version: 21.1;Level: LLT;Classification code 10037403;Term: Pulmonary hypertension NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Sotatercept
Product Code: MK-7962
INN or Proposed INN: Sotatercept
Merck Sharp & Dohme LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2United States;Spain;Turkey;Israel;Colombia;United Kingdom;France;Mexico;Poland;Australia;South Africa;Netherlands;Germany
3EUCTR2020-005061-13-AT
(EUCTR)
05/05/202202/12/2021A 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/ MK-7962
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011/ MK-7962
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Serbia;Portugal;United States;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden
4NCT04811092
(ClinicalTrials.gov)
March 18, 202216/3/2021Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)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 PatientsPulmonary Arterial HypertensionDrug: Sotatercept;Other: PlaceboAcceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)NULLRecruiting18 YearsN/AAll662Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czechia;Denmark;France;Germany;Greece;Israel;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Portugal;Serbia;Spain;Sweden;Switzerland;Taiwan;United Kingdom
5EUCTR2020-005061-13-BE
(EUCTR)
07/03/202226/11/2021A 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 / MK-7962
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011 / MK-7962
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Serbia;Portugal;United States;Taiwan;Greece;Israel;Colombia;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;New Zealand;Sweden;Spain
6EUCTR2020-005061-13-CZ
(EUCTR)
02/03/202220/12/2021A 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 / MK - 7962
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011 / MK-7962
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3Serbia;Portugal;United States;Taiwan;Greece;Spain;Israel;Colombia;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Croatia;Germany;New Zealand;Sweden
7EUCTR2020-005061-13-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/ MK-7962
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Product Name: Sotatercept - 45 mg/vial
Product Code: ACE-011 / MK-7962
INN or Proposed INN: SOTATERCEPT
Other descriptive name: ActRIIA-IgG1Fc
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Phase 3United States;Czechia;Portugal;Greece;Austria;Sweden;Netherlands;Poland;Brazil;Korea, Republic of;France;Serbia;Croatia;Colombia;Argentina;United Kingdom;Switzerland;Spain;New Zealand;Canada;Czech Republic;Belgium;Taiwan;Denmark;Mexico;Italy;Israel;Australia;Germany
8NCT04896008
(ClinicalTrials.gov)
December 1, 202113/5/2021A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)A 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 MortalityPulmonary Arterial HypertensionDrug: Sotatercept;Other: PlaceboAcceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)NULLRecruiting18 Years75 YearsAll200Phase 3United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Mexico;Netherlands;Spain;United Kingdom
9NCT04796337
(ClinicalTrials.gov)
May 12, 202122/2/2021A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004)An 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 PAHPulmonary Arterial Hypertension;PAHBiological: SotaterceptAcceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)NULLRecruiting18 YearsN/AAll700Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czechia;Denmark;France;Germany;Greece;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Portugal;Serbia;Spain;Sweden;Switzerland;Taiwan;United Kingdom
10NCT04576988
(ClinicalTrials.gov)
January 25, 202128/9/2020A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)A 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 PAHPulmonary Arterial HypertensionBiological: Sotatercept;Drug: Placebo;Drug: Background PAH TherapyAcceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)NULLCompleted18 YearsN/AAll324Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;France;Germany;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Serbia;Spain;Sweden;Switzerland;United Kingdom