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Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAH

Pulmonary Arterial Hypertension Clinical Trial

Official title:
An Open-label, Multicentre Study to Evaluate Pharmacokinetics, Safety and Efficacy of Zamicastat as Adjunctive Therapy in Pulmonary Arterial Hypertension (PAH)

Clinical Trial Summary

This Study evaluates the pharmacokinetic (PK) profile of different zamicastat doses in Pulmonary arterial hypertension (PAH) patients to find the most promising therapeutic dosage range for the treatment of PAH disease

Clinical Trial Description

This is an open-label, multi-centre study in patients with PAH who are currently on stable treatment with at least one PAH medication. It is planned to evaluate the PK profile (24 hour profile and trough levels) and the safety, tolerability and efficacy of four different zamicastat doses. Each patient will start treatment with the lowest dose (50 mg zamicastat once daily) and the dose will be up-titrated to the individual highest tolerated dose (HTD) i.e. up to 200 mg zamicastat once daily. A data safety monitoring board (DSMB) will periodically review the safety data and will issue a recommendation if the doses can be used as planned. This study will consist of: - A screening period, 5 to 12 days: visit V1 - Up to four dose finding periods, 14 days each: - Dose A: visits A1, A2 and A3 - Dose B: visits B2 and B3 - Dose C: visits C2 and C3 - Dose D: visits D2 and D3 - Maintenance period, 42 days: visits MPV1, MPV2 and MPV3 - Follow-up period, 14 to 28 days: visits FU (down-titration) and FU ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04316143
Study type Interventional
Source Bial - Portela C S.A.
Contact
Status Completed
Phase Phase 2
Start date June 6, 2019
Completion date October 20, 2021
View Details
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