NCT04605549

A Study of CIN-107 in Adults With Primary Aldosteronism

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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 investigator's 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.

Conditions

• Primary Aldosteronism
• Hyperaldosteronism

Interventions

Type	Name	Description
DRUG	CIN-107 2 mg dosing	One tablet of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 2 mg.
DRUG	CIN-107 4 mg dosing	Two tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 4 mg.
DRUG	CIN-107 8 mg dosing	Four tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 8 mg.

Timeline

• Start date: 2021-03-08
• Primary completion: 2024-10-28
• Completion: 2024-10-28
• First posted: 2020-10-28
• Last updated: 2026-03-03
• Results posted: 2026-03-03

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study