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A Study of CIN-107 in Adults With Primary Aldosteronism

CompletedPhase 2

Sponsor: AstraZeneca

Conditions: Primary Aldosteronism, Hyperaldosteronism

Interventions: CIN-107 2 mg dosing, CIN-107 4 mg dosing, CIN-107 8 mg dosing

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Have been diagnosed with PA.
2. Are taking mineralocorticoid receptor antagonist (MRA) to control BP; or are newly diagnosed with PA and have not started MRA treatment.
3. Are willing and able to cease dosing of MRA for up to 4 weeks in patients taking MRA.
4. Are willing to be compliant with the contraception and reproduction restrictions of the study.
5. Have increased SBP by ≥ 20 mmHg or have SBP ≥ 160 mmHg after dosing of MRA treatment is ceased for up to 4 weeks duration, or have SBP ≥ 150 mmHg for patients who are newly diagnosed with PA and have not taken an MRA in the past 12 weeks.

Exclusion Criteria:

1. At Screening Visit, have a single occurrence of mean seated SBP \> 180 mmHg or DBP \> 110 mmHg if not taking an MRA; or have a mean seated SBP ≥ 160 mmHg or DBP ≥ 100 mmHg if currently taking an MRA.
2. Have a body mass index \> 45 kg/m2.
3. Have had a previous surgical intervention for an adrenal adenoma or have a planned adrenal carcinoma, adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study.
4. Have a documented estimated glomerular filtration rate \< 45 mL/min/1.73 m2.
5. Have a planned dialysis, kidney transplantation or any major surgical procedure during the course of the study.
6. Have known documented New York Heart Association class III or IV chronic heart failure.
7. Have had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before the Screening Visit.
8. Have known current severe left ventricular outflow obstruction.
9. Have had major cardiac surgery within 6 months before the Screening Visit.
10. Have a history of, or currently experiencing, clinically significant arrhythmias.
11. Have had a prior solid organ transplant or cell transplant.
12. Are positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen.
13. Have typical consumption of \> 14 alcoholic drinks weekly.

Locations (10)

Greenbrae, California, United States
San Francisco, California, United States
West Hollywood, California, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
Rochester, Minnesota, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Dallas, Texas, United States