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Active (not recruiting) Phase 3 2025-521970-33-00

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 (MK-7962-038)

Phase 3 – large-scale trial before approval
Conditions: ​​Pulmonary Arterial Hypertension (PAH)

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
Trial status: Authorised Change From Baseline in 6-Minute Walk Distance (6MWD), Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels, Change From Baseline in the Percentage of Participants Who Improve or Show Maintenance in Modified New York Heart Association/World Health Organization Classification of Functional Status (WHO FC), Change From Baseline in Pulmonary Vascular Resistance (PVR), Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low-Risk Score Using the Simplified French Risk Score Calculator Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Number of Participants With Detectable Anti-drug Antibodies (ADAs), Hematology Parameters: Concentration of Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin, and Hematocrit, Chemistry Parameters: Concentration of Blood Urea,Creatinine,Total & Direct Bilirubin,Aspartate Aminotransferase,Alanine Transaminase,Alkaline Phosphatase,Sodium,Potassium,Chloride,Calcium,Phosphorous,Glucose,Magnesium,Carbon Dioxide, & Albumin, Change From Baseline in Body Weight, Change From Baseline in Blood Pressure, Change From Baseline in Electrocardiogram (ECG)
Description
Change From Baseline in 6-Minute Walk Distance (6MWD), Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels, Change From Baseline in the Percentage of Participants Who Improve or Show Maintenance in Modified New York Heart Association/World Health Organization Classification of Functional Status (WHO FC), Change From Baseline in Pulmonary Vascular Resistance (PVR), Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low-Risk Score Using the Simplified French Risk Score Calculator
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 389 participants
Interventions
SOTATERCEPT
Drug
SOTATERCEPT
Drug
sotatercept
Drug
sotatercept
Drug
Locations 13
Belgium (1)
Croatia (1)
Czech Republic (1)
Denmark (1)
France (1)
Germany (1)
Greece (1)
Italy (1)
Netherlands (1)
Poland (1)
Portugal (1)
Spain (1)
Sweden (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.12.2025
Registry ID
2025-521970-33-00
Source
euclinicaltrials.eu
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