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NCT06009185Completed

Safety and Efficacy of BIA 5-1058 in PAH

An Open-label, Multicentre Study to Evaluate the Safety and Efficacy of Zamicastat as Adjunctive Therapy in Long-term Treatment of Pulmonary Arterial Hypertension (PAH) Disease
Bial - Portela C S.A.Phase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Pulmonary Arterial Hypertension
Drug/Device/Intervention
Oral zamicastat
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Bial - Portela C S.A.
Location
Linz,Dresden,Monza,Roma,Lisboa,Barcelona,Madrid,Salamanca,Santander,Clydebank,London, Austria,Germany,Italy,Portugal,Spain,United Kingdom
Timeline & enrollment
Phase
Phase 2
Start date
Jun 26, 2019
End date
Feb 17, 2022
Enrollment
20 participants
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
Primary pulmonary hypertensionOther secondary pulmonary hypertensionPulmonary heart disease and diseases of pulmonary circulationStenosis of pulmonary arteryPulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06009185
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.