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
| 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 | NCT05587712 (ClinicalTrials.gov) | January 19, 2023 | 17/10/2022 | Study 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 Care | Pulmonary Arterial Hypertension | Drug: Sotatercept | Merck Sharp & Dohme LLC | NULL | Recruiting | 1 Year | 17 Years | All | 42 | Phase 2 | United States |
| 2 | EUCTR2022-000478-25-ES (EUCTR) | 23/12/2022 | 13/10/2022 | Sotatercept in Children with Pulmonary Artery Hypertension on Standard of Care | 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 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 LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 2 | United States;Spain;Turkey;Israel;Colombia;United Kingdom;France;Mexico;Poland;Australia;South Africa;Netherlands;Germany | ||
| 3 | EUCTR2020-005061-13-AT (EUCTR) | 05/05/2022 | 02/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | 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 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, USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;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 | ||
| 4 | NCT04811092 (ClinicalTrials.gov) | March 18, 2022 | 16/3/2021 | Study 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 Patients | Pulmonary Arterial Hypertension | Drug: Sotatercept;Other: Placebo | Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | NULL | Recruiting | 18 Years | N/A | All | 662 | Phase 3 | United 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 |
| 5 | EUCTR2020-005061-13-BE (EUCTR) | 07/03/2022 | 26/11/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | 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 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, USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;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 | ||
| 6 | EUCTR2020-005061-13-CZ (EUCTR) | 02/03/2022 | 20/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | 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 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, USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | Serbia;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 | ||
| 7 | EUCTR2020-005061-13-PL (EUCTR) | 26/01/2022 | 02/12/2021 | A Long-term Follow-up Study of Sotatercept for PAH Treatment | 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 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, USA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 700 | Phase 3 | United 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 | ||
| 8 | NCT04896008 (ClinicalTrials.gov) | December 1, 2021 | 13/5/2021 | A 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 Mortality | Pulmonary Arterial Hypertension | Drug: Sotatercept;Other: Placebo | Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | NULL | Recruiting | 18 Years | 75 Years | All | 200 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Mexico;Netherlands;Spain;United Kingdom |
| 9 | NCT04796337 (ClinicalTrials.gov) | May 12, 2021 | 22/2/2021 | A 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 PAH | Pulmonary Arterial Hypertension;PAH | Biological: Sotatercept | Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | NULL | Recruiting | 18 Years | N/A | All | 700 | Phase 3 | United 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 |
| 10 | NCT04576988 (ClinicalTrials.gov) | January 25, 2021 | 28/9/2020 | A 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 PAH | Pulmonary Arterial Hypertension | Biological: Sotatercept;Drug: Placebo;Drug: Background PAH Therapy | Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) | NULL | Completed | 18 Years | N/A | All | 324 | Phase 3 | United 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 |