A Study of CIN-107 in Adults With Primary Aldosteronism

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04605549
Study type	Interventional
Source	AstraZeneca
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	March 8, 2021
Completion date	October 10, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02885662` - Study of CS-3150 in Patients With Primary Aldosteronism	N/A
Withdrawn	`NCT02096939` - Microvascular Function in Primary Aldosteronism	N/A
Completed	`NCT01728493` - Primary Aldosteronism in General Practice: Organ Damage, Epidemiology and Treatment	N/A
Recruiting	`NCT06228677` - Comparison of Catecholamine Concentrations in Venous Blood During Selective Adrenal Artery Embolization
Recruiting	`NCT06047912` - Screening for Primary Aldosteronism in Hypertension With 24-hour URinary aLdosterone
Recruiting	`NCT04991961` - Effect of Anti-hypertensive Medications on the Diagnostic Accuracy in Screening for Primary Aldosteronism
Recruiting	`NCT05501080` - The Effect of SAAE on Ventricular Remodeling in PA Patients	N/A
Recruiting	`NCT05405101` - Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA	N/A
Recruiting	`NCT05973604` - Prevalence of Primary Aldosteronism in Atrial Fibrillation
Recruiting	`NCT05826080` - Effect of Adrenocorticotropic Hormone Stimulation During Adrenal Vein Sampling in Primary Aldosteronism
Completed	`NCT04179019` - Calcium Channel Blockade in Primary Aldosteronism	Phase 2
Completed	`NCT03500120` - Diagnostic Accuracy of Seated Saline Suppression Test for Primary Aldosteronism
Recruiting	`NCT04213963` - Prospective Study on Primary Aldosteronism in Resistant Hypertension
Completed	`NCT05435703` - Renal Cysts and Primary Aldosteronism
Recruiting	`NCT02945904` - IS Metomidate PET-CT Superior to Adrenal Venous Sampling in Predicting Outcome From Adrenalectomy in Patients With Primary Hyperaldosteronism
Enrolling by invitation	`NCT02257450` - Primary Aldosteronism in Malaysia: A Nationwide Multicentre Study	N/A
Recruiting	`NCT05561361` - The Effect of SAAE on Vascular Endothelial Function in PA Patients
Completed	`NCT03398785` - Adrenal Artery Ablation Treats Primary Aldosteronism	Phase 3
Recruiting	`NCT03224312` - Chongqing Primary Aldosteronism Study
Recruiting	`NCT04428827` - Outcome of Patients With Primary Aldosteronism