A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN)
Condition: Resistant Hypertension
MeSH terms: Hypertension
Intervention: CIN-107; Placebo
Intervention description: CIN-107 tablets by mouth once daily; placebo tablets by mouth once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 275.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 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).
    

Eligibility criteria:

        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.