A Study of CIN-107 in Patients With Uncontrolled Hypertension
Condition: Uncontrolled 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: 249.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of
      multiple dose strengths of baxdrostat (also called CIN-107) in the treatment of patients with
      uncontrolled hypertension. The primary objective was to demonstrate that treatment with
      baxdrostat for 8 weeks would lower the systolic blood pressure (SBP) in patients who were
      hypertensive despite taking one or two anti-hypertensive medications.

      Participants were assigned to take placebo or baxdrostat once per day for 8 weeks while they
      continued taking the regular anti-hypertensive medications. At the end of the 8-week period,
      qualified patients could participate in Part II of the study and receive 2 mg baxdrostat for
      4 weeks while they discontinued taking the background anti-hypertensive medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is on a stable regimen of background antihypertensive agent(s) for at least 8 weeks
             and would be considered a candidate for an additional antihypertensive agent at the
             time of screening ;

          -  Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHg or ≥ 130 mmHg if diabetic;

          -  Demonstrates ability to be adherent to the study drug and their anti-hypertensive
             medication during a run-in period

          -  If taking an SGLT2 inhibitor, the regimen must be stable for at least 8 weeks prior to
             randomization; and

          -  Agrees to comply with the contraception and reproduction restrictions of the study;

        Exclusion Criteria:

          -  Has a mean seated systolic blood pressure (SBP) ≥180 mmHG;

          -  Has a body mass index (BMI) >50 kg/m2;

          -  Is using alpha or beta blockers for any primary indication other than systemic
             hypertension (eg, migraine headache);

          -  Is not willing or not able to discontinue an MRA or potassium sparing diuretic as part
             of an existing antihypertensive regimen;

          -  Has documented estimated eGFR <30 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;

          -  Major cardiac surgery within 6 months before Screening;

          -  Has chronic permanent atrial fibrillation;

          -  Has uncontrolled diabetes with glycated hemoglobin >10% at Screening;

          -  Has planned dialysis or kidney transplantation planned during the course of the study;

          -  Prior solid organ transplant and/or cell transplants;

          -  Sodium <130 mEq/L;

          -  Potassium <3.5 mEq/L;

          -  Potassium >5 mEq/L;

          -  White blood cell count >15 × E9/L or absolute neutrophil count <1 × E9/L at Screening;

          -  Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;

          -  Has typical consumption of ≥14 alcoholic drinks weekly;