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A Study of CIN-107 in Adults With Primary Aldosteronism
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, at doses from 2 to 8 mg per day, for the management of blood pressure in patients with primary aldosteronism (PA).
Call 214-648-5005
studyfinder@utsouthwestern.edu, Natalie.Booker@UTSouthwestern.edu
Oksana Hamidi
179331
All
18 Years and over
Phase 2
NCT04605549
STU-2021-0884
Inclusion Criteria:
• Have been diagnosed with PA.
• Are taking mineralocorticoid receptor antagonist (MRA) to control BP; or are newly diagnosed with PA and have not started MRA treatment.
• Are willing and able to cease dosing of MRA for up to 4 weeks in patients taking MRA.
• Are willing to be compliant with the contraception and reproduction restrictions of the study.
• 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:
• 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.
• Have a body mass index > 45 kg/m2.
• 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.
• Have a documented estimated glomerular filtration rate < 45 mL/min/1.73 m2.
• Have a planned dialysis, kidney transplantation or any major surgical procedure during the course of the study.
• Have known documented New York Heart Association class III or IV chronic heart failure.
• Have had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before the Screening Visit.
• Have known current severe left ventricular outflow obstruction.
• Have had major cardiac surgery within 6 months before the Screening Visit.
• Have a history of, or currently experiencing, clinically significant arrhythmias.
• Have had a prior solid organ transplant or cell transplant.
• Are positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen.
• Have typical consumption of > 14 alcoholic drinks weekly.
Drug: CIN-107 2 mg dosing, Drug: CIN-107 4 mg dosing, Drug: CIN-107 8 mg dosing
Hyperaldosteronism, Other Endocrine System, Primary Aldosteronism
Primary Aldosteronism
UT Southwestern