A Study of CIN-107 in Adults With Primary Aldosteronism (NCT04605549) | Clinical Trial Compass
CompletedPhase 2
A Study of CIN-107 in Adults With Primary Aldosteronism
United States15 participantsStarted 2021-03-08
Plain-language 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.
Who can participate
Age range18 Years – 130 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Number of Treatment Emergent Adverse Events
Timeframe: 74 weeks
2
Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) in Patients With Primary Aldosteronism
✕. 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.