A Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Dose Strengths of CIN-107 as Compared to Placebo After 8 Weeks of Treatment in Patients With Uncontrolled Hypertension

CIN-107-124

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.

2021-12-07

2022-09-13

2022-10-10

Completed

Early phase I

249

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;

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2023-08-01