Safety and Efficacy of BIA 5-1058 in PAH - Trial NCT06009185
Access comprehensive clinical trial information for NCT06009185 through Pure Global AI's free database. This Phase 2 trial is sponsored by Bial - Portela C S.A. and is currently Completed. The study focuses on Pulmonary Arterial Hypertension. Target enrollment is 20 participants.
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Study Focus
Sponsor & Location
Bial - Portela C S.A.
Timeline & Enrollment
Phase 2
Jun 26, 2019
Feb 17, 2022
Primary Outcome
Number of participants with adverse events (AEs),Clinically relevant changes in laboratory parameters: coagulation,Incidence of clinically relevant changes (abnormalities) in laboratory parameters: biochemistry,Incidence of clinically relevant changes (abnormalities) in laboratory parameters: haematology,Clinically relevant changes in laboratory parameters: urinalysis,Clinically relevant changes in laboratory parameters: arterial blood gas,Clinically relevant changes in vital signs: blood pressure,Clinically relevant changes in vital signs: pulse rate,Clinically relevant changes in electrocardiogram ECG parameter QT interval,Clinically relevant changes in electrocardiogram ECG parameter QRS duration
Summary
This study aims to assess the safety and tolerability of the individual highest tolerated
 zamicastat doses, achieved in the study BIA-51058-201, during long-term treatment in
 Pulmonary Arterial Hypertension (PAH) disease.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06009185
Non-Device Trial