Title
A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN)
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 12 Weeks of Treatment in Patients With Treatment-Resistant Hypertension (rHTN)
Phase
Phase 2Lead Sponsor
CinCor Pharma, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Resistant HypertensionIntervention/Treatment
CIN-107 ...Study Participants
275This is a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study to evaluate the efficacy and safety of CIN-107 as compared to placebo after 12 weeks of treatment in patients with treatment-resistant hypertension (rHTN).
placebo tablets by mouth once daily
Subjects received placebo tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
Subjects received CIN-107 0.5 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
Subjects received CIN-107 1 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
Subjects received CIN-107 2 mg tablets, administered orally once daily for 12 weeks. Subjects continued taking stable anti-hypertensive regimen throughout the study.
Inclusion Criteria: Is on a stable regimen of ≥ 3 antihypertensive agents (one of which is a diuretic) for at least 4 weeks prior to randomization; Be at least 70% compliant to their anti-hypertensive medication regimen; Has a seated BP ≥ 130/80 mmHg; Agrees to comply with the contraception and reproduction restrictions of the study; and Able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines. Exclusion Criteria: Has a seated SBP ≥ 180 mmHg or DBP ≥ 110 mmHg; Has a body mass index (BMI) > 40 kg/m2; Has an upper arm circumference < 7 or > 17 inches; Has been on night shifts at any time during the 4 weeks before Screening; Is using a beta blocker for any primary indication other than systemic hypertension (eg, migraine headache); Is not willing or not able to discontinue an MRA or a potassium sparing diuretic as part of an existing antihypertensive regimen; Is not willing or not able to discontinue taking a potassium supplement; Has documented estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2 Has known and documented New York Heart Association stage III or IV chronic heart failure Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before Screening; Has known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease diagnosed from a prior echocardiogram; Major cardiac surgery (eg, CABG, valve replacement), peripheral arterial bypass surgery, or PCI within 6 months before Screening; Has chronic permanent atrial fibrillation; Has uncontrolled diabetes with glycosylated hemoglobin > 9.5% at Screening; Has planned dialysis or kidney transplant during the course of this study; Potassium < 3.5 mEq/L; Potassium > 5.0 mEq/L; Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen; Has typical consumption of ≥14 alcoholic drinks weekly.
| Event Type | Organ System | Event Term | Safety Population 0.5mg | Safety Population 1mg | Safety Population 2mg | Safety Population Placebo |
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