Pharmacokinetics, Safety and Efficacy of BIA 5-1058 in PAH
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pulmonary Arterial Hypertension
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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 patie...
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
Tracking Information
- NCT #
- NCT04316143
- Collaborators
- Not Provided
- Investigators
- Not Provided
Get Well Soon