Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04605549
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2020-10-22
Brief Title:
A Study of CIN-107 in Adults With Primary Aldosteronism
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multicenter Open-Label Study to Evaluate the Safety Tolerability and Effectiveness of CIN-107 for the Management of Blood Pressure in Patients With Primary Aldosteronism
Status:
ACTIVE_NOT_RECRUITING
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 is a multicenter open-label study in adult patients with PA to evaluate the effectiveness and safety of CIN-107 after up to 12 weeks of treatment Part 1 and then for eligible consenting patients follow patients in Part 2 for up to 74 weeks for evidence of long-term safety and tolerability
Detailed Description:
For patients in Part 1 only
The treatment duration for patients who complete all 3 dose levels and who opt not to continue in the extension part of the study is 12 weeks For patients who do not complete up-titration the treatment duration will include at least 4 weeks of dosing with the final dose level If down-titration of CIN-107 dose is determined at Visit 6 Week 9 the total treatment duration may be extended to 13 weeks to allow sufficient time for CIN-107 treatment effect at the final dose to be assessed If the final dose of CIN-107 is reached before week 8 Visit 5 and no up-titration occurs at Visit 5 the patients will be encouraged to continue CIN-107 treatment till Visit 7 for a total of 12 weeks of treatment The patients who opt not to continue to Part 2 will not receive any study drug and will return for their safety follow up visit Visit 8 in 2 weeks
For patients who opt to continue in the extension part Part 2 of the study
Patients will continue to receive their dose of baxdrostat and be instructed to measure BP at least once every week prior to dosing with CIN-107 in the morning during the extension phase Safety surveillance will be conducted if clinically indicated Repeat and unscheduled testing for serum potassium may be measured at the investigators clinical site or at local laboratory for a faster turn-around time to allow clinical assessment These patients entering part 2 will skip Visit 8 and their next visit will be Visit 9
The treatment duration for patients who complete all 3 dose levels and who opt not to continue in the extension part of the study is 12 weeks For patients who do not complete up-titration the treatment duration will include at least 4 weeks of dosing with the final dose level If down-titration of CIN-107 dose is determined at Visit 6 Week 9 the total treatment duration may be extended to 13 weeks to allow sufficient time for CIN-107 treatment effect at the final dose to be assessed If the final dose of CIN-107 is reached before week 8 Visit 5 and no up-titration occurs at Visit 5 the patients will be encouraged to continue CIN-107 treatment till Visit 7 for a total of 12 weeks of treatment The patients who opt not to continue to Part 2 will not receive any study drug and will return for their safety follow up visit Visit 8 in 2 weeks
For patients who opt to continue in the extension part Part 2 of the study
Patients will continue to receive their dose of baxdrostat and be instructed to measure BP at least once every week prior to dosing with CIN-107 in the morning during the extension phase Safety surveillance will be conducted if clinically indicated Repeat and unscheduled testing for serum potassium may be measured at the investigators clinical site or at local laboratory for a faster turn-around time to allow clinical assessment These patients entering part 2 will skip Visit 8 and their next visit will be Visit 9
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| D6970C00001 | OTHER | AstraZeneca | None |