Ignite Creation Date:
2024-05-06 @ 2:25 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04316143
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2020-03-18
Brief Title:
Pharmacokinetics Safety and Efficacy of BIA 5-1058 in PAH Zamicastat
Sponsor:
Bial - Portela C SA
Organization:
Bial - Portela C SA
Study Overview
Official Title:
An Open-label Multicentre Study to Evaluate Pharmacokinetics Safety and Efficacy of Zamicastat as Adjunctive Therapy in Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 ie 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 50 mg zamicastat once daily visits A1 A2 and A3
Dose B 100 mg zamicastat once daily visits B2 and B3
Dose C 150 mg zamicastat once daily visits C2 and C3
Dose D 200 mg zamicastat once daily visits D2 and D3
Maintenance period 42 days maintenance period visit MPV1 MPV2 and MPV3
Follow-up FU period 14 to 28 days visits FU down-titration and FU
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 50 mg zamicastat once daily visits A1 A2 and A3
Dose B 100 mg zamicastat once daily visits B2 and B3
Dose C 150 mg zamicastat once daily visits C2 and C3
Dose D 200 mg zamicastat once daily visits D2 and D3
Maintenance period 42 days maintenance period visit MPV1 MPV2 and MPV3
Follow-up FU period 14 to 28 days visits FU down-titration and FU
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-002448-10 | EUDRACT_NUMBER | None | None |